July 2016 – FDA to Release Announcement Major Generic Drug Labeling Rule

generic

The US Food and Drug Administration (FDA) has now said it will release in July a controversial and major final rule that would allow generic drug companies to update their labels with new safety information like their reference product counterparts have done for almost 30 years.
Background

Under current FDA regulations, generic drug companies with abbreviated new drug applications (ANDAs), unlike companies with new drug applications (NDAs) and biologics license applications (BLAs), cannot independently update product labeling with newly acquired safety information.

That means that when a generic company notices a safety issue that has yet to either crop up or be indicated on its reference product’s label (or the reference product is no longer even produced), the generic company cannot do anything to notify the public of an imminent concern, which raises serious liability issues.

As the proposed rule notes, the current regulatory difference between ANDA holders and NDA and BLA holders means that an individual can bring a product liability action for “failure to warn” against an NDA holder, but generally not an ANDA holder.

As Focus has extensively reported in the past (Read our Regulatory Explainer on the regulation of generic drug labeling), FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update safety labeling.

FDA first unveiled the proposed rule in November 2013, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, but has been deliberating, holding public meetings, and re-opening the federal docket for more comments (the last comment period closed in April).

If finalized, the rule would permit a sponsor of a generic drug to immediately issue a labeling change for any safety-related change, starting a process intended to allow differences to exist between the generic drug, the brand-name reference product and other approved generic drugs on a “temporary basis.”

The labeling change application to FDA would need to contain information such as the basis for the labeling change and available data to support the change, such as adverse event data, published literature or epidemiologic studies.

“The rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements,” FDA says.
New Rule’s Pushback

Without going into much detail, FDA now says it’s “considering several alternatives” described in the more than 23,000 comments submitted to the public docket and considering the financial implications and benefits that would be associated with a final rule, which it plans to release sometime in July, after twice pushing back its release date.

And unlike some in the generic industry, who oppose the rule (to the point of suing FDA) and claim it would expose them to billions of dollars in new legal liabilities, patient advocacy groups are angered by the delay and are pushing for FDA to finalize the rule as quickly as possible.

“The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients,” Dr. Michael Carome, director of the Public Citizen Health Research Group, said in a statement on Thursday. “The agency should move expeditiously to finalize its proposed rule, which will better protect patients by ensuring they have timely access to updated safety information.”

The Generic Pharmaceutical Association, meanwhile, said Thursday that it’s “pleased” FDA will continue to evaluate the wide range of concerns expressed with the agency’s proposal, which would require “generic manufacturers to update labels based on incomplete information without first receiving FDA approval. However, no single manufacturer has access to the full range of available data — the proprietary data from clinical studies or the data held by each individual applicant holder.”

Source : raps.org

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Market growth and the price of generic drugs

generic-drugs-medicine

Had those generic drugs been subject to the same requirement that branded drugs face—where manufacturers pay additional rebates to Medicaid when the price of a drug increases faster than inflation—Medicaid would have pulled in $1.4 billion in rebates for the top 200 generic drugs, according to the report.

The OIG produced the report in response to a request from Congress to examine recent increases in generic drug prices and the effects of those prices on Medicaid and Medicare drug spending. In recent months, Congress has upped its scrutiny of rising drug prices.

Some of the attention stems from the now-infamous announcement by Turing Pharmaceuticals and its CEO, Martin Shkreli, that the company planned to raise the price of generic drug Daraprim, which is used to treat toxoplasmosis, from $13.50 to $750 a pill.

Turing has since backed away from that plan, and on Thursday Shkreli was indicted for alleged securities fraud. The charges were not directly related to the drug price increase, according to the Associated Press.

In this latest report, the OIG didn’t make any recommendations, noting that that the two-year budget deal recently passed by Congress would extend the rebates to generics starting in 2017. In a previous, similar report, OIG had recommended CMS consider seeking legislative authority to broaden the rebate program.

Erin Fox, director of drug information at the University of Utah Health Care’s Drug Information Service, said applying the rebates to generics might lead generic manufacturers to rein in price hikes to avoid having to pay the rebates. Or, she said, manufacturers could go in the opposite direction and raise prices even higher to make up for the rebates.

Lawmakers who support the change say applying the rebates to generics will help keep prices down.

“It is unacceptable that Americans pay, by far, the highest prices in the world for prescription drugs,” Sen. Bernie Sanders (I-Vt.) said in a May statement after introducing legislation proposing the rebate change. “For years, generic drugs have made it possible for people to buy the medicine they need at lower prices,” said Sanders, who is running for the Democratic nomination for president. “We need to make certain that generics remain affordable.”

Others, however, fear that applying the rebates to generics will hurt the industry and consumers who rely on generics as lower-priced alternatives to brand-name drugs.

In a recent op-ed in The Hill, Chip Davis, CEO of the Generic Pharmaceutical Association, warned that applying the rebates to generics “will add significant hurdles to generic drug investment and development, making it more challenging for generics to serve as a viable alternative to more expensive brand medications for patients and payers—the exact opposite of what both patients and payers need.”

Dana Goldman, director of the Schaeffer Center for Health Policy and Economics at the University of Southern California, said that if the rebates sink manufacturers’ profits too much, competitors could exit the market leaving single suppliers with the ability to raise prices significantly such as what happened with Turing, he said.

If anything, this latest OIG report should be evidence that the generics market is already working well as it is, he said.

“You could say for 80% of the drugs, the price competition is quite thorough and robust,” Goldman said, referring to the 78% of generic drug prices reviewed in the report that were not rising faster than inflation.

The percentage of generic drug prices rising faster than inflation also seems to have fallen over time. A previous OIG review on the same topic for 1991 through 2004 pegged the amount of generic drug prices rising faster than inflation at 35%. Had the rebates been applied over that time period, Medicaid would have pulled in an additional $966 million for the top 200 generic drugs, according to the OIG.

Goldman said he’s more concerned about companies such as Turing pumping up prices by astronomical amounts than he is about prices for some drugs rising slightly faster than inflation.

John Rother, president and CEO of the National Coalition on Health Care—whose members include providers, unions, insurers and employers—said the OIG report merely describes what’s been an ongoing issue in the generics industry. He said when it comes to the problem of rising drug prices, branded drugs are the real culprit.

Rother has headed a campaign to lower drug prices in recent years.

“It’s hardly the major issue in the prescription drug pricing debate,” Rother said of generics pricing. “It’s a pretty small piece of the pie.”

 

 

 

 

 

 

 

Source : http://www.modernhealthcare.com

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Adverse Events that long-term use of esomeprazole

nexium

There are a number of potential adverse events that might arise from Nexium use. These include the following:
Hip fracture

There is some evidence that long-term use of esomeprazole can increase the chances of hip fracture.

Proton pump inhibitors can interfere with calcium absorption, potentially weakening bones. Their use may also impact on normal bone recycling by inhibiting proton pumps that are involved in bone creation and remodeling.

Nexium could increase the risk of Clostridium difficile based diarrhea, according to a number of studies.
Clostridium difficile based diarrhea

Some evidence suggests that Nexium and other proton pump inhibitors might cause an increased rate of Clostridium difficile-based diarrhea.
Pneumonia

One study found a 30% increased chance of developing hospital-acquired pneumonia in patients prescribed proton pump inhibitors.
Polyps

Nexium and other proton pump inhibitors are associated with the development of benign polyps on the fundic glands (secretory areas of the stomach). Nexium is not, however, associated with cancer.

Kidney damage
Some studies have recently found a correlation between proton pump inhibitors and chronic kidney disease. At this stage, it is not clear whether the link is causal.10
Nutritional

Some evidence suggests that, because gastric acid breaks down food, there may be some nutritional deficits if the acid is not present. Some studies have shown a possible interference with the absorption of calcium, iron and vitamin B12.11

There are many confounding variables, however, and how these factors interact is not yet fully understood. The strongest evidence for nutritional shortfalls is in regard to magnesium.12
Nexium interactions with other drugs

Nexium is a competitive inhibitor of the enzyme CYP2C19, so other drugs that rely on this enzyme might be affected by its use. For instance, diazepam and warfarin are broken down by CYP2C19. Levels of these drugs in the body might rise if taken alongside a proton pump inhibitor.

Other drugs, such as clopidogrel (Plavix) depend on CYP2C19 to be converted into their active form; their effect will therefore be reduced if taken alongside esomeprazole.

A change in stomach acidity also changes the way certain drugs are absorbed. Some drugs require an acidic environment to be absorbed, such as ketoconazole or atazanavir. Others, including erythromycin, are degraded by stomach acid, so in more alkaline situations they will be absorbed in greater quantities.

 

Source : http://www.medicalnewstoday.com

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Drug information about Nexium (Esomeprazole) with his side effect

nexium

In this article, we will investigate what ailments Nexium is used for, how it works, its side effects and whether or not it has any contraindications.

Esomeprazole (brand name Nexium) relieves a number of stomach-related complaints. It works by blocking a proton pump and reducing the production of acid in the stomach.

Fast facts on Nexium

Here are some key points about Nexium. More detail and supporting information is in the main article.

  • Nexium is a proton pump inhibitor
  • Proton pump inhibitors are some of the most widely sold drugs in the world
  • Side effects of Nexium include headache, nausea and flatulence
  • The main effect of esomeprazole is a marked decrease in stomach acid production
  • Nexium use might increase the risk of hip fractures
  • Proton pump inhibitors inhibit hydrogen potassium ATPase
  • Nexium is predominantly used to treat gastroesophageal reflux
  • Nexium might prevent certain nutrients from being broken down and absorbed
  • Nexium is a competitive inhibitor of the enzyme CYP2C19.

What is Nexium?
Nexium is a proton pump inhibitor and reduces the amount of acid produced in the stomach.
Proton pump inhibitors such as Nexium substantially reduce stomach acid secretion. The site of action for this group of drugs is the parietal cells in the stomach wall; these cells secrete hydrochloric acid and intrinsic factor (an important factor in the absorption of vitamin B12).

The drug works by inhibiting hydrogen potassium ATPase (H+/K+ ATPase), a transporter that is responsible for acidifying the stomach.

Nexium is most commonly used to treat the following conditions:

– Dyspepsia: also known as indigestion. Symptoms include upper abdominal fullness, nausea, heartburn and upper abdominal pain
– Peptic ulcer disease: a gap in the lining of the stomach, oesophagus or intestine
– Gastroesophageal reflux disease (GERD): a chronic condition where the mucosa is damaged by stomach acid coming up from the stomach into the esophagus; the main symptom is heartburn. Nexium’s reduction of stomach acid eases the symptoms of GERD and prevents damage to the oesophagus
– Zollinger-Ellison syndrome: a pancreatic tumor overstimulates the production of stomach acid.

Nexium is sometimes used by patients who are taking nonsteroidal anti-inflammatory drugs (NSAIDs). This is due to NSAIDs’ propensity to produce stomach ulcers; Nexium helps prevent their formation.

There are a number of proton pump inhibitors available, including Aciphex, Zegerid, Prilosec, Protonix and Prevacid. When used for milder diseases, Nexium’s effects are comparable to other similar drugs on the market. However, Nexium appears to be more effective than some others when used in particularly severe cases.

Esomeprazole also appears to increase erosive esophageal healing, compared with some other leading brands.

Side effects of Nexium
The most common side effects of Nexium are:

  1. Headache
  2. Diarrhea
  3. Nausea
  4. Flatulence
  5. Decreased appetite
  6. Constipation
  7. Dry mouth
  8. Unusual taste in the mouth
  9. Abdominal pain.

Severe, rarer side effects of Nexium include:

  1. Severe allergies
  2. Dark urine
  3. Chest or back pain
  4. Acne
  5. Changes in heart rhythm
  6. Fever
  7. Yellow coloration of the eyes or skin
  8. Extreme fatigue and muscle weakness
  9. Unusual bleeding or bruising
  10. Paresthesia (experiencing a tingling or prickly sensation)
  11. Persistent sore throat
  12. Severe stomach pain.

 

Source : http://www.medicalnewstoday.com

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Do not easily believe online diagnostic results

online-diagnosing

Health consultations online, it is easy and flexible for all of us. But we must be careful – careful not to blindly believe and confirming the diagnosis the doctor says online. Seek a second opinion to a doctor you trust, if it does not allow you to come to the doctor. Below is taken from the web site about the need to be careful – careful with medical consultation online.

We called her the “White Bread Lady,” a moniker she earned for one particularly inane call in which she panicked to my father after consuming white bread.

She wasn’t breaking out in hives or having any adverse effects to the bread. No, she was just concerned that some future illness could befall her given that one particular dietary decision.

Although we all laughed at the time, it was with a bit of shifty-eyed shame. Because most of us (including if not particularly the illustrious Ehrlich family) have lurking within us our very own “White Bread Lady,” ready to convince us that each cough, sniffle and less-than-nutritious meal might be a detriment to our health.

And, naturally, that White Bread Lady looms even larger when we can type our worries into a search bar and unlock a bevy of potentially distressing information. Yup, so quoth Google, we all have cancer.

According to a recent report from the Pew Research Center, 80% of Internet users have looked up health information online. While that practice can be beneficial in some respects, the abundance of (variably valid) information online can turn us into e-hypochondriacs. (Or, worse, can lead us to neglect getting the care we need.)

Read on for five mistakes — courtesy of a selection of health-care professionals — that people make when diagnosing themselves online.

Searching blind

Your eye is twitching like an overly caffeinated college student sitting behind a pretty girl in lecture hall, twirling his pencil and hoping to catch a whiff of her lovely shining hair.

You type “eye twitch” into Google and come up with a really rad website that explains that this newfound spasm is actually an indication that your third eye is fixing to open, revealing to you wonders untold. You are the chosen one. Too bad that this trove of “medical information” is actually some dude’s fan-fiction site.

Long wait at the doctor’s office? Blame the patients

Sure, the above is an extreme example, but, as Dr. Kevin Pho of KevinMD.com pointed out, “There’s a lot of bad information on the Web and information that can be dangerous.” Especially if you’re not considering who put up that information in the first place.

Pho urges users to favor Web addresses ending in .org and .edu when looking for reputable health-care info, and to check who is funding the collection of that information. “There’s so much information from organizations trying to sell products or push their agenda on the Web,” he said.

He suggests turning to sites like Mayo Clinic as well as troves of information curated by doctors (like Pho’s own website) when trolling the Web for info. And, of course, if a site mentions trolls and third eyes, one should definitely press on.

Flailing in forums

If there’s one thing people like to do online, it’s talk about their problems — especially mundane things like coughs and headaches and their babies’ various and sundry discharges. And, it seems, we’re pretty interested in reading about the health issues of others, too.

According to that Pew study, 23% of social-network users have followed a friend’s health experiences online, and 34% of Internet users have read about someone else’s medical issues on newsgroups, websites or blogs.

That’s all well and good; sharing experiences with others is enriching! Unless the people you’re sharing with are idiots.

Case in point: Here’s a Yahoo Answers thread in which folks are discussing whether you can make a pregnancy test out of bleach and Pine-Sol. (Spoiler alert: You can’t.)

“You can easily fall into that rabbit hole and find some forum that really isn’t relevant but maybe sounds kind of close,” warned Craig Monsen, co-founder of symptom-checker app SymCat and fourth-year medical student at Johns Hopkins University.

On the other hand, “sometimes you’ll stumble on exactly the right forum where someone has your same exact problem, and their solution does help.”

Doctor-turned-kayaker fights malaria in Uganda

“Health-care forums are definitely another tool that individuals can use in order to crowdsource a diagnosis based on their symptoms,” added Dr. Natasha Burgert of KC Kids Doc. “I think that these can be a really powerful tool not only for discussing potential diagnosis or symptom relief but also finding a forum of individuals in which you can discuss emotional and psychological parts of an illness and develop a wonderful online support community.”

The trick is to be wary about the issues being discussed in forums and how germane they are to you. And, you know, if people start talking about homemade remedies fashioned from bleach, maybe click off and see a doc.

Getting emotional

You know that game “6 Degrees of Kevin Bacon”? There should seriously be a version of that called “6 Degrees of Cancer” — as in, when looking up your symptoms online, how long does it take to deduce that you have a life-threatening disease instead of, say, a simple cold?

According to Burgert, the root of this whole “worst-case scenario” thing is getting too emotional.

“For most intents and purposes, when you’re looking for online health information, it’s about yourself or a family member,” she said. “When you’re looking through that lens, it’s very hard to keep emotional distance. So you can read about a diagnosis that either makes you very scared or calms your fears — and that’s the path you’ll continue down, whether it’s correct or not.”

Burgert suggested using online symptom checkers simply to “understand possible diagnoses, find some initial steps for relieving the symptoms and determine if this is something that needs further evaluation or that can be managed at home.”

SymCat and Mayo Clinic’s symptom checker let you type in what you’re experiencing and unearth a spectrum of diagnoses and suggestions for when to seek a doctor’s aid. Your doctor’s website might also have such a tool.

Voila, you just increased your separation from cancer by at least a couple of degrees.

Keeping mum around MDs

“I think, traditionally, many physicians are a little apprehensive when that stereotypical patient comes to their office with big stacks of printouts from the Internet,” Pho said. “But I think more and more doctors are accepting it. Personally, I think that transparency of information is helpful in a way.”

Translation: Help your doctor help you. If you’re worried about a particular medical situation and did some research to help narrow down what’s ailing you, share that info with your physician.

“I really appreciate when patients bring in information that they found online, because it allows me to guide my instruction and plan based on their true concerns,” Burgert said. “People get scared when they get sick and hurt, and they want to use multiple sources of information to help themselves. The Internet adds to that physician’s expertise in order to do that.”

Study: Fainting may have genetic link

Pho suggests using tracking apps (Bloodnote and Tap & Track are a few examples) to keep tabs on blood pressure, weight, heart rate and other areas that are of particular concern to you and your MD.

“These apps and sites give patients so much data about themselves that they never had before,” he said.

And a log is useful to your doctor, who can scan for abnormalities and patterns that you may have missed.

Remember, though, knowing how to use the Internet doesn’t make you a doctor. Google doesn’t count as a second opinion. If you’re unhappy with your doc’s diagnosis, go get one the traditional way.

Putting off the inevitable

If your ailment isn’t going away, all the symptom-checking and Mayo Clinic-ing in the world isn’t going to help you.

Make a doctor’s appointment. Like, right now.

Sites like ZocDoc make it super easy (and free; doctors pay to be listed) to set up an appointment ASAP, so no whining that you’ll have to wait two weeks to see a doc and maybe by then “it” will have gone away.

Unless, of course, “it” is that white bread you just ate. In that case, please stop calling my dad.

source : http://edition.cnn.com

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What are must be understood about generic medicines

generic-drugs-medicine

When we buy medicine, maybe you will see two types of drugs, namely branded and generic. Its branded drug prices are much more expensive than generic medicines. Then, what about the quality of generic medicines themselves? of the articles below may help you understand what generic medicines.

Medical Author: Melissa Stoppler, M.D.
Medical Editor: Barbara K. Hecht, Ph.D.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

An example of a generic drug, one used for diabetes, is metformin. A brand name for metformin is Glucophage. (Brand names are usually capitalized while generic names are not.) A generic drug, one used for hypertension, is metoprolol, whereas a brand name for the same drug is Lopressor.

Many people become concerned because generic drugs are often substantially cheaper than the brand-name versions. They wonder if the quality and effectiveness have been compromised to make the less expensive products. The FDA (U.S. Food and Drug Administration) requires that generic drugs be as safe and effective as brand-name drugs.

Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect.

As the patent nears expiration, manufacturers can apply to the FDA for permission to make and sell generic versions of the drug; and without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further.

So there’s no truth in the myths that generic drugs are manufactured in poorer-quality facilities or are inferior in quality to brand-name drugs. The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacture both brand-name and generic drugs. In fact, the FDA estimates that 50% of generic drug production is by brand-name companies.

Another common misbelief is that generic drugs take longer to work. The FDA requires that generic drugs work as fast and as effectively as the original brand-name products.

Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications. Trademark laws in the United States do not allow the generic drugs to look exactly like the brand-name preparation, but the active ingredients must be the same in both preparations, ensuring that both have the same medicinal effects.

Reference: Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Generic Drugs: What you need to know. 2009.

Source : http://www.medicinenet.com

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Consumption of generic drugs in the US increased

medicine-store

In 2015, the development of generic drugs in the United States increased their consumption. proving that socialization has gone well, and prove the quality of generic drugs the same as the branded drug. Here are some facts about generic drugs:

FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs.  

Generics have the same quality as brand name drugs. When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product.
The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured.  If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.
Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.
All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.

FACT:  Research shows that generics work just as well as brand name drugs.

A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand name heart drugs worked any better than generic heart drugs.

FACT:    FDA does not allow a 45 percent difference in the effectiveness of the generic drug product.

FDA recently evaluated 2,070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was 3.5 percent. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name drug. In fact, there have been studies in which brand name drugs were compared with themselves as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.
Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.

FACT: When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand name product.

In 2010 alone, the use of FDA-approved generics saved $158 billion, an average of $3 billion every week.

FACT: Cheaper does not mean lower quality.

Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices.

FACT: FDA monitors adverse events reports for generic drugs.

The monitoring of adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval. Many times, reports of adverse events describe a known reaction to the active drug ingredient.
Reports are monitored and investigated, when appropriate. The investigations may lead to changes in how a product (brand name and generic counterparts) is used or manufactured.

FACT:  FDA is actively engaged in making all regulated products – including generic drugs – safer.

FDA is aware that there are reports noting that some people may experience an undesired effect when switching from brand name drug to a generic formulation or from one generic drug to another generic drug. FDA wants to understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products.
FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur. The Agency does not have the resources to perform independent clinical studies and lacks the regulatory authority to require industry to conduct such studies. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises.

Source : http://www.fda.gov

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The use of generic drugs is a High Value Care way to improve health, avoid harms, and eliminate wasteful practices

generic-vs-brand-cost

In the development of the use of generic drugs, doctors should further support the use of generic drugs which are more affordable than expensive branded drugs. Generic drugs are supported by the government by the value of research and research is not cheap. With the same quality generic drugs should take precedence.

Conducted by members of the American College of Physicians’ (ACP) Clinical Guidelines Committee, the report is published in the Annals of Internal Medicine.

While the use of generic drugs has increased over time, the authors say that many health care providers continue to prescribe expensive brand-name drugs when cheaper generic alternatives are available – an issue that is likely to contributing to high health care costs; around $325 billion is spent on prescription drugs each year in the US.

By reviewing around 2,500 studies of prescription practices, the ACP assessed how often doctors prescribed brand-name drugs when generic alternatives were available.

The Committee also looked at how the prescription of generic medications affects treatment adherence, whether brand name and generic drugs produce similar clinical effects, what the barriers are to increasing use of generic medications and what can be done to overcome such barriers.

“The purpose of this article is to help guide internists and other clinicians in making high-value, cost-conscious decisions about the use of generic drugs,” the authors explain.
Generic drugs can be ‘just as effective as brand-name counterparts’

On assessing the frequency of brand-name drug prescription, the authors found that – as expected – health care providers often prescribe brand-name drugs over the generic equivalents.

They point to a 2008 study, for example, that found 23-45% of prescriptions for Medicare beneficiaries with diabetes were for branded medications that had generic equivalents.

Fast facts about prescription drug use

  1. Around 48.7% of Americans have used at least one prescription drug in the past 30 days
  2. More than 10% of Americans have used five or more prescription drugs in the past 30 days
  3. In 2010, more than 75% of doctor’s visits results in a drug prescription.

The authors estimated that for Medicare beneficiaries with diabetes alone, substituting brand-name prescription drugs for generic alternatives combined with therapeutic interchange – prescribing drugs that are chemically different but therapeutically similar – would save $1.4 billion.

The majority of peer-reviewed studies found that generic equivalents to brand-name drugs produced similar clinical outcomes, according to the authors, despite some physicians expressing concern that generic medications are less effective or cause more severe side effects.

“For example, a meta-analysis of 47 studies compared the effectiveness of generic and brand-name drugs in nine classes of cardiovascular medications and found no evidence of superiority of brand-name medication, including among anticoagulants and antiarrhythmics with narrow therapeutic windows,” they explain.

However, the ACP admit there are some situations where a brand-name drug may be more clinically appropriate than its generic alternative, or cases where prescribing an alternative is not possible.

The authors found that long-term adherence to treatment could be improved with increased prescription of generic medications, noting that prescriptions for branded medications are almost twice as likely to go uncollected after being filled than generic medications.

This is likely because brand-name drugs are significantly more costly than generic medications, though the authors note that the price of generic medications has been increasing recently.

Based on the findings of the report, ACP President Dr. Wayne J. Riley says:

 

“The use of generic drugs is a High Value Care way to improve health, avoid harms, and eliminate wasteful practices.”

 

 

 

 

 

 

Concerns about safety, efficacy of generic drugs fueling underuse

The authors cite a national survey that found, while most patients believed generic drugs were cheaper and better value than brand-name drugs, only 36% of Americans said they preferred to use them.

They believe the underuse of generic drugs is likely fueled by patient concerns about their safety and efficacy, with many believing that because they are cheaper, they will be less effective.

“Differences in the physical appearance of molecularly identical generics and between generics and their brand-name counterparts could also influence patient perceptions of efficacy or safety; such variations in pill appearance have been associated with higher rates of nonadherence,” say the authors.

Physicians are also concerned about the safety and efficacy of generic medications, according to the report, with one survey finding that around a quarter of doctors preferred that themselves and their family did not use them. Such a perception means that many doctors are unlikely to prescribe generic medications to patients.
Recommendations to increase prescribing of generic medications

Given the improved treatment adherence and cost savings associated with use of generic medications over brand-name drugs, the ACP concludes:

“Clinicians should prescribe generic medications, if possible, rather than more expensive brand-name medications.”

As such, the organization recommends a number of strategies to help increase prescription of generic drugs over brand-name drugs.

The authors suggest generic prescribing could be boosted through the uptake of electronic medical records, which will inform health care providers of the “formulary status of prescribed medications, as will be required by the ‘meaningful use’ criteria of the Affordable Care Act.”

Physician behavior could be altered through continued interactive education, such as academic detailing, according to the authors, who note that this could better inform doctors about the safety and efficacy of generic medications.

In addition, they suggest generic medications should be subject to similar public awareness and advertising campaigns as branded drugs; this may help change patient perception toward generic drugs.

Policy levers, such as tiered formularies – health plans incorporating lists of generic and brand-name drugs divided into groups based on cost and effectiveness – have proven effective for increasing use of generic medications, the authors note.

However, they point out that “current copayment differentials between generic and brand-name medications may not be sufficient to motivate generic drug use by some patients; thus, a need for further research about these behavior change tools also remains.”

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Should to know about acid reflux : Causes, Symptoms, and Treatments #2

gastroesophageal_reflux

Tests and diagnosis

The first port of call for someone experiencing frequent acid reflux symptoms is the family doctor, who may refer on to a specialist in gut medicine, a gastroenterologist.

Gastroesophageal reflux disease is often diagnosed simply by finding no improvement in heartburn symptoms in response to lifestyle changes and acid reflux medication.

Gastroenterologists may also arrange the following investigations:

  1. Endoscopy (camera imaging)
  2. Biopsy (taking a tissue sample for laboratory analysis)
  3. Barium X-ray (imaging the esophagus, stomach and upper duodenum after swallowing a chalky liquid that helps provide contrast on images)
  4. Esophageal manometry (pressure measurement of the esophagus)
  5. Impedance monitoring (measuring rate of fluid movement along the esophagus)
  6. pH monitoring (acidity testing).

Treatment and prevention of acid reflux

The main treatment option for people who repeatedly experience acid reflux in gastroesophageal reflux disease is a class of drugs known as proton-pump inhibitors (PPIs for short).
Zantac – for heartburn relief
Zantac, a medication for heartburn relief, was one of the first blockbuster drugs.

The mode of action of proton-pump inhibitors is to decrease acid production and thereby reduce the potential for damage caused by acid reflux.

Here is the full list of proton-pump inhibitors available on prescription in the US (brand names given followed by generic names, 2014):

– Aciphex (rabeprazole)
– Dexilant (dexlansoprazole)
– Nexium (esomeprazole)
– Prevacid (lansoprazole)
– Prilosec (omeprazole; also available in pharmacies without prescription)
– Protonix (pantoprazole)
– Zegerid (immediate-release omeprazole with sodium bicarbonate).

Proton-pump inhibitors are generally safe and effective, but like any prescription drug, they are not appropriate for all people with reflux disease and can cause side-effects, such as malabsorption issues leading to nutrient deficiencies.

PPIs are blockbuster drugs – prescribed to millions and earning huge sums for pharmaceutical firms because of their common use.

Proton-pump inhibitors have superseded earlier drug therapies that were used for gastroesophageal reflux disease – H2 blockers (also known as H2-receptor antagonists). These were the first blockbuster drugs of modern medicine – Zantac (ranitidine), for example, was the drug that caused GlaxoSmithKline to become a key pharmaceutical giant.
Over-the-counter remedies for acid reflux

For people who experience heartburn or indigestion infrequently, perhaps in association with occasional food and drink triggers, treatments to reduce the acidity of the stomach contents are available without prescription from pharmacies (over-the-counter products).

These liquid and tablet formulations are called antacids and there are dozens of brands available, all with similar effectiveness. They may not work for everyone, and any need for regular use should be discussed with a doctor.

Antacids provide rapid but short-term relief by buffering the acidity through simple chemical reaction with the stomach contents (they do not act on acid-producing cells of the stomach lining).

They contain chemical compounds such as calcium carbonate, sodium bicarbonate, aluminum, and magnesium hydroxide, and can also inhibit nutrient absorption, leading to deficiencies over time.
Alginate drugs such as Gaviscon
Box of Gaviscon
Gaviscon is a well known over-the-counter heartburn medication

Gaviscon is probably the best known heartburn therapy, available over the counter at pharmacies. It has a different mode of action than antacid drugs, containing alginic acid. Alginate drugs such as this brand vary slightly in composition, but they usually also contain an antacid.

The alginic acid works by creating a mechanical barrier against the stomach acid, forming a foamy gel that sits at the top of the gastric pool itself. Any reflux is then relatively harmless as it consists of alginic acid and not damaging stomach acid

The active ingredient alginate is found naturally in brown algae.

Other options

The main options for the management of gastroesophageal reflux disease have been covered above. A long list of other therapies is available, however, with one pharmacological review listing the following additional options: sucralfate acid suppressants, potassium-competitive acid blockers, transient lower esophageal sphincter relaxation (TLESR) reducers, GABA(B) receptor agonist, mGluR5 antagonist, prokinetic agents, pain modulators, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and the serotonin-norepinephrine reuptake inhibitor theophylline.

Surgery

In rare cases, gastroesophageal reflux disease that is severe and unresponsive to medical treatment may warrant surgical intervention in the form of a procedure called fundoplication – the National Institutes of Health has detailed information about this operation at Medline.

Prevention of acid reflux through lifestyle control

As discussed above, lifestyle can play a large part in the development of acid reflux-related problems, and changes to lifestyle or behavior can prevent or improve symptoms.

One summary of the actions patients might take has been compiled by the American Gastroenterological Association. This includes advice for patients with troublesome irritation to keep a diary, so that they may find any links to lifestyle factors.

The American Gastroenterological Association also offers the following list of things to try to see if symptoms resolve:

  • Avoid food, drinks and medicines that you find to be associated with heartburn irritation
  • Eat smaller meals
  • Do not lie down for two to three hours after a meal
  • Lose weight if overweight or obese
  • Avoid increased pressure on your abdomen, such as from tight belts or doing sit-up exercises
  • Stop smoking.

There is also some suggestion that eradication of infection with Helicobacter pylori can lead to the development of gastroesophageal reflux disease, although this has only been seen so far in Asian countries where the prevalence of H. pylori infection is higher than in western countries.

Risks from long-term GERD

It is important to address persistent problems with gastroesophageal reflux disease as long-term untreated acid reflux can lead to serious complications including an increased risk of cancer.

Long-term, continual exposure to stomach acid can damage the esophagus, leading to:

  • Esophagitis – where the lining of the esophagus is inflamed, causing irritation, bleeding and ulceration in some cases
  • Strictures – where the damage caused by stomach acid leads to scar development and difficulties swallowing, with food getting stuck as it travels down the esophagus
  • Barrett’s esophagus – a serious complication where repeated exposure to stomach acid causes changes in the cells and tissue lining the esophagus replacing normal cells with those that resemble cells in the lower gastrointestinal tract. This is considered a premalignant condition.

Both esophagitis and Barrett’s esophagus are associated with a higher risk of cancer.

Esophagitis may lead to precancerous changes in the pipe, and Barrett’s esophagus carries a clear risk of lethal cancer for a small number of patients.

There was a landmark study published in the New England Journal of Medicine in 1999 that found a link between untreated acid reflux and cancer. Its conclusion reads as a stark warning against leaving acid reflux untreated for a long time:

 

    “There is a strong and probably causal relation between gastroesophageal reflux and esophageal adenocarcinoma.”

 

 

 

 

 

 

 

Source : http://www.medicalnewstoday.com

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Should to know about acid reflux : Causes, Symptoms, and Treatments #1

gastroesophageal_reflux

Many are looking for health problems of acid reflux. Symptoms that occur when exposed to acid reflux and how to handle. A very common symptom of burning pain felt internally around the lower chest area, caused by stomach acid flowing back up into the food pipe.

Gastroesophageal reflux disease (GERD, or GORD for gastro-oesophageal reflux disease) is acid reflux more than twice a week.

Use this page to learn what causes acid reflux and gastroesophageal reflux disease. Also get an overview of symptoms, and how the condition is diagnosed. We outline the treatment options available for the management of the condition, and how lifestyle measures may have preventive benefit.

You will also see introductions at the end of some sections to any recent developments that have been covered by MNT’s news stories. Also, look out for links to information about related conditions.

Fast facts on acid reflux

Here are some key points about acid reflux. More detail and supporting information is in the main article.

  • Acid reflux is also known as heartburn, acid indigestion, or pyrosis.
  • It happens when some of the acidic stomach contents go back up into the esophagus.
  • Acid reflux creates a burning pain in the lower chest area, often after eating.
  • Gastroesophageal reflux disease (GERD) is acid reflux that persists more often than twice a week.
  • GERD is very common in the US and other western populations.
  • Lifestyle risk factors include obesity and smoking.
  • Drug treatments are the mainstay of therapy and are available on prescription and over the counter.
  • Left untreated, gastroesophageal reflux disease can have serious complications, including an increased risk of cancer.

What is acid reflux?

Acid reflux is when some of the acid content of the stomach flows up into the esophagus – into the gullet, which moves food down from the mouth.
Diagram of esophagus, stomach and digestive system

The stomach contains a strong acid, hydrochloric acid, to help with the efficient digestion of food and to protect against undesirable microbes such as bacteria.

The lining of the stomach is specially adapted to produce this acid, and also to protect the digestive organ against its own corrosive secretion, but the higher gut is not protected from this acid.

A ring of muscle – the gastroesophageal sphincter – normally protects the esophagus from the contents of the stomach by acting as a valve that lets food into the stomach but not back up into the esophagus. When this valve fails and stomach contents are regurgitated into the esophagus, the symptoms of acid reflex are felt, such as heartburn. This is also known as pyrosis or acid indigestion.

Exact figures vary but acid reflux is considered very common, and diseases resulting from acid reflux are the most common gut complaint seen by US hospital departments.

The American College of Gastroenterology says that over 60 million Americans experience heartburn at least once a month, and at least 15 million as often as daily.

Gastroesophageal reflux disease has the highest burden in western countries, affecting an estimated 20-30% of the population. Americans are especially prone to GERD, likely due to a higher prevalence of several lifestyle risk factors, which are explored below.

What causes acid reflux?

We all may experience acid reflux occasionally, often associated with certain food and drink. Recurrent acid reflux that leads to disease has other causes and risk factors, and is termed gastroesophageal reflux disease (GERD or GORD).

Gastroesophageal reflux disease is seen in people of all ages, sometimes for unknown reasons (idiopathic).7 Often the cause is attributable to a lifestyle factor, but it can also be due to causes that cannot always be prevented.

One such cause of GERD is a hiatal (or hiatus) hernia. This is an anatomical abnormality where a hole in the diaphragm allows the upper part of the stomach to enter the chest cavity, sometimes leading to GERD.

Pregnancy is also sometimes a cause of acid reflux due to extra pressure being placed on the internal organs.

Other risk factors are more easily controlled and often directly linked to modifiable lifestyle or dietary issues, including:

  • Obesity
  • Smoking (active or passive)
  • High intake of table salt
  • Low dietary fibre intake
  • Low levels of hysical exercise
  • Medications, including drugs for asthma, calcium-channel blockers, antihistamines, painkillers, sedatives, and antidepressants.

Individuals may report an association with certain food and drinks but research suggests there is not any link between gastroesophageal reflux disease and intake of alcohol, coffee or tea.

The animation from YouTube below, produced by the Mayo Clinic, shows how stomach acid looks in the digestive system, and the action of the gastroesophageal sphincter (valve) as it allows reflux into the esophagus.


Signs and symptoms of acid reflux

Acid reflux, whether it is a harmless, isolated episode of the sort we all experience at some point, or the persistent problem of gastroesophageal reflux disease, usually produces the same main symptom:

  • Heartburn

Heartburn is a discomfort – happening in the esophagus and felt behind the breastbone area – that takes the form of a burning sensation and which tends to worsen when the person lies down or bends over. It can last for several hours and also tends to worsen after eating food.

The burning pain may move up toward the neck and throat as stomach fluid can reach the back of the throat in some cases, producing a bitter or sour taste.

We all experience heartburn occasionally, due to simple acid reflux, but if this occurs regularly – two or more times a week – it is termed gastroesophageal reflux disease, or GERD for short. GERD can also be signalled by other symptoms, including:

  • Dry, persistent cough
  • Wheezing
  • Asthma and recurrent pneumonia
  • Nausea
  • Vomiting
  • Throat problems – soreness, hoarseness, or laryngitis (voice box inflammation)
  • Difficulty or pain when swallowing
  • Chest or upper abdominal pain
  • Dental erosion
  • Bad breath.

Source : http://www.medicalnewstoday.com/

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