Problems Again with Plavix

We have 8 other posts about Plavix, several listing natural blood thinning alternatives.  Feel free to contact us if you have questions.

Doctors have been left to figure out if Plavix will work in their patients and how best to protect them if it doesn’t. The confusion follows this month’s FDA warning that Plavix may not work well in certain patients.

Plavix is used to prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. It is also given to patients who’ve undergone coronary stent procedures to prevent clots from forming inside the devices. The medication keeps the platelets in the blood from coagulating to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

On March 12, the FDA warned that Plavix may be less effective in people who cannot metabolize the drug to convert it to its active form. According to a notice on the FDA Web site, Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19. People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. These “poor metabolizers” may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

In May 2009, the FDA added this warning to the Plavix label. In its latest alert, the agency said that after reviewing more data, it felt it was important to highlight this risk in a Black Box, its strongest safety notice.

According to a report in today’s Wall Street Journal, as many as 4 percent of patients have two copies of a variation in a gene for CYP2C19 that makes them poor metabolizers. For patients of Chinese decent, the rate could be as high as 14 percent. The new Black Box warning is directed at such patients.

But according to the Journal, of concern is another group of patients, 25 to 30 percent, who have one copy of this variation. At least one study suggests that these patients may also have a degree of inhibition to the drug’s effectiveness.

To insure that Plavix is working doctors have a couple of options. One is a genetic test to determine if a patient carries this gene variation. Patients who test for the variant could be put on a higher dose of Plavix. Unfortunately, insurance won’t always cover this test, and according to the Journal, some doctors point out that whether using the tests will actually decrease risk for patients hasn’t been well studied.

Another option is switching to a drug called Effient, which was recently approved and which isn’t affected by the genetic variant. According to the Journal, doctors have been slow to use Effient because it does carry a higher risk of bleeding than Plavix.

In the meantime, doctors are advising against patients going off Plavix without first talking to their own physicians.

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Posted in: blood thinners,Effient,health risk of blood thinning drugs,natural blood thinning,Plavix

Health Coaching would have alerted you sooner to FDA finding on Plavix and acid drugs

FROM Heartwire: Cardiologists Shocked by New FDA Alert on Clopidogrel-PPI Interaction
I am shocked that cardiologists are shocked because all they had to do was to take just a little time to review the literature and do a drug interaction profile.  Had they done this, something that takes about 5 minutes, they would have been able to know that the acid blocking drugs interfere with the P450 detox pathway and also proetin digestion.  Additionally they could have learned about the nutrient depletions and related problems from both of these drugs.  Not to overlook the risk of silent bleeding as well,..

Are things so bad that this is the level of health care we are getting because Big PhARMA and Big Insurance is behind obstruction of health reform?

Previously posted articles, related issues -
Resolve Acid Reflux with Care, Naturally
Natural Blood Thinning

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Recently, Dr. Mehmet Oz told Larry King on CNN about how health coaches can solve America's health crisis. Even five years ago it would have been hard to imagine that prevention and wellness would be considered in the mainstream.

CHI has been offering health coaching for several decades in a very unique way that has led us to the place where we seeking a patent.

If you were learning about natural health approaches to health problem you might not be at risk for this drug interaction problem and you'd be saving a lot of money at the same time.

If you are looking for in depth information about your prescription drugs and what you can safely use in their place you might wish to use our services. We have many patients who use this service and get the information they need to protect their health and learn how to advocate for their own health as well as how to ask the right questions when they see their health care provider.
 
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FDA says heartburn drugs can interfere with Plavix


By MATTHEW PERRONE, AP Business Writer Matthew Perrone

WASHINGTON – Federal health officials said Tuesday a popular variety of heartburn medications can interfere with the blood thinner Plavix, a drug taken by millions of Americans to reduce risks of heart attack and stroke.

The Food and Drug Administration said the stomach-soothing drugs Prilosec (20 mg average price $132/mo) and Nexium (20 mg average price $211/mo) cut in half the blood-thinning effect of Plavix (75 mg average price $211/mo), known generically as clopidogrel.

Regulators said the key ingredient in the heartburn medications blocks an enzyme the body needs to break down Plavix, muting the drug's full effect. Procter & Gamble's Prilosec is the over-the-counter version of AstraZeneca's Nexium, which was first approved in 2001.

"Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine," the agency said in a statement.

Plavix is marketed by Sanofi-Aventis and Bristol-Myers Squibb. With global sales of $8.6 billion last year, it's the world's second-best selling drug behind Pfizer's cholesterol drug Lipitor.

Because Plavix can upset the stomach, it is often prescribed with stomach acid-blocking drugs.

The FDA says patients who need to reduce their acid should take drugs from the H-2 blocker family, which include Johnson & Johnson's Mylanta and Boehringer Ingelheim's Zantac. FDA scientists say there is no evidence those drugs interfere with Plavix's blood clotting.

Nexium and Prilosec are part of a class of drugs known as proton pump inhibitors, but FDA regulators said they don't have enough information to say whether other drugs in that class shouldn't be used with Plavix.

"There's not enough data to tell us how those drugs interact with," the enzyme that activates Plavix, said Mary Ross Southworth, FDA's deputy director for safety of cardiovascular products. "There are ongoing studies looking at those other drugs."

The FDA said the warnings on Plavix have been strengthened based on a 150-patient study submitted by Sanofi over the summer.

Information about the drug interaction between Plavix and certain heartburn medications is not new. Researchers reported last year that taking Plavix with Nexium significantly increased patients' chances of being hospitalized for a heart attack, stroke or chest pain.

In January, Sanofi and Bristol-Myers updated Plavix's labeling to advise against using it in combination with certain heartburn drugs.

A Sanofi spokeswoman said Tuesday that the company has bolstered that language labeling.

"We've strengthened the label to say that these drugs should be avoided altogether, not just discouraged," said Noelle Boyd, Sanofi's senior communications director.

http://www.leaflady.org/Drugs.htm

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Posted in: blood thinning,health coach,Health Detective,heartburn,heartburn drugs,Nexium,Plavix,Prilosec

Healthy Suggestion

UPDATE 8 May: Plavix et al and Anti-Acid Drugs Again in the News:

Benefits Of Anti-clotting Medications Reduced By Common Heartburn Drugs

ScienceDaily (2009-05-07) -- Proton pump inhibitors interfere with anti-clotting protection of clopidogrel. The anti-clotting action of the medication clopidogrel can be compromised by common drugs for the treatment of heartburn and ulcers resulting in a roughly 50 percent increase in the combined risk of hospitalization for heart attack, stroke and other serious cardiovascular illnesses, according to a new study. ... > read full article

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One of the most popular items at Natural Health News has been a post I made back in November about Plavix and Nexium.

Plavix (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2S•H2SO4 and its molecular weight is 419.9.

Gastrointestinal and intracranial hemorrhage as well as other bleeding events are a risk of this drug.

Plavix Postmarketing Experience: The following events have been reported spontaneously from worldwide postmarketing experience:

Body as a whole:
- hypersensitivity reactions, anaphylactoid reactions, serum sickness
Central and Peripheral Nervous System disorders:
- confusion, hallucinations, taste disorders
Hepato-biliary disorders:
- abnormal liver function test, hepatitis (non-infectious), acute liver failure
Platelet, Bleeding and Clotting disorders:
- cases of bleeding with fatal outcome (especially intracranial, gastrointestinal and retroperitoneal hemorrhage)
- thrombotic thrombocytopenic purpura (TTP) - some cases with fatal outcome - (see WARNINGS)
- agranulocytosis, aplastic anemia/pancytopenia
- conjunctival, ocular and retinal bleeding
Respiratory, thoracic and mediastinal disorders:
- bronchospasm, interstitial pneumonitis
Skin and subcutaneous tissue disorders:
- angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, lichen planus
Renal and urinary disorders:
- glomerulopathy, increased creatinine levels
Vascular disorders:
- vasculitis, hypotension
Gastrointestinal disorders:
- colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis
Musculoskeletal, connective tissue and bone disorders:
- myalgia

You can learn more about Plavix at http://www.rxlist.com/plavix-drug.htm#ad

Allegedly, according to the manufacturer, Nexium or other proton pump inhibitors are taken with Plavix to reduce the risk of gastrointestinal bleeding. However it is also pointed out that the risk of heart attack with this combination is about 50% higher that if you were not taking the PPI drug.

Interestingly enough there are a number of natural appraoches to reducing platelet aggregation that are certainly less effective and do not seem to create risk of GI or other serious bleeding.

Plavix costs about $1.50 a pill.

Other products that will reduce platelet aggregation are aspirin, vitamin E, garlic, and natto. There are also herbs that will help support this process such as red clover and ginkgo.

Generally, with natural products you do not run the risk of major bleeding are risk of heart attack.

And if you are also concerned about GERD, not related to combined use with other drugs, you might consider -

PPI drugs may deplete Calcium, Folic acid, Vitamin B12* and Vitamin C

Vinegar for gastic distress

1 teaspoon of organic unfiltered apple cider vinegar in a glass of pure water
about 20 minutes before meals reduces reflux.

or Chamomile tea, or the tea with added tincture, rebalances gastric acidity.

or a simple glass of water sipped slowly (no ice) reduces stomach acid.

or the use of high quality digestive enzymes (simply4health full spectrum enzymes) and evaluation of the amount of HCl present in your stomach as low levesl of HCl contribute to GERD.

Consider too that lecithin granules do a lot to improve the flexibility and health of your arteries and reduce risk of arteriosclerosis. Plain yoghurt mixed with applesauce also helps this condition.
***
Long term side effect of stomach acid blockers such as Pepcid, Tagamet, Zantac, Prilosec - Potentially harmful acidity develops in the tissues of the body when the system's ability to eliminate the acids that are produced (metabolic waste, acid forming foods, and the system's various stress mechanisms) is reduced. The stomach is one of the primary venting mechanisms for this build up of hydrogen ions (acids are typified by an abundance of such ions) and when our stomach's acid producing mechanisms are pharmaceutically inhibited, the hydrogen ion concentrations become too abundant to be efficiently eliminated by other pathways of elimination. Consequently, the acids build up in the tissues and fluid compartments of the body, where they greatly interfere with the normal cellular functions. The overly acidic condition of the intercellular fluid compartment makes it an ideal breeding ground for harmful micro-organisms, creating an enormous burden on the immune system. This build-up can lead to fatigue, poor mental and emotional health and eventual chronic degenerative illness.

A Second Opinion -
Plavix clopidogrel by Ray Sahelian, M.D. Benefit and side effects of Plavix medication

Plavix is a prescription medication marketed by Sanofi-Aventis and Bristol-Myers Squibb. Plavix was launched in 1998. It is currently marketed in over 80 countries.

Cardiologists are re-evaluating how they prescribe Plavix, a popular heart medication used to prevent blood clots, after a major clinical study found the drug may cause dangerous bleeding in patients who take it along with aspirin to ward off a first heart attack. Some people taking the blood thinner Plavix on top of aspirin to try to prevent heart attacks, as many doctors recommend, now have good reason to stop. The Plavix and aspirin combination not only didn’t help most people, but it unexpectedly almost doubled the risk of death, heart attack or stroke for those with no clogged arteries but with worrisome conditions like high blood pressure and high cholesterol.

Plavix danger in combination with proton pump inhibitors
Patients with stents who take Plavix with prescription heartburn drugs, including AstraZeneca PLC’s Nexium, are significantly more likely to be hospitalized for a heart attack, stroke, chest pain or a coronary artery bypass operation than those who take Plavix alone.

Q. I read that taking Plavix and Nexium is dangerous. I am taking Plavix and Zantac. Is this dangerous too? I had a heart attack and a stent was put in my artery. I then was put on Aspirin (325 mg), Plavix (75 mg), and Zantac because I have stomach ulcer. I had sever nose bleeding after 2 weeks taking the above medications. My cardiologist reduced aspirin to 81 mg. I don't know how I will tolerate this new regiment.
A. Nexium and Zantac work in different ways so I don't know if Zantac, an H2 antihistamine, would have a similar interaction with Plavix as would Nexium, a proton pump inhibitor.

People who suffer a heart attack nearly double the risk of having another if they are taking the widely used blood thinner Plavix together with a heartburn drug like Prilosec. Plavix, also known as clopidogrel and made by Sanofi-Aventis SA and Bristol-Myers Squibb Co, and aspirin are often used to thin a patient's blood after a heart attack. Doctors also may prescribe a proton pump inhibitor, or PPI, such as AstraZeneca Plc's heartburn drug Prilosec to cut the risk of gastrointestinal bleeding from bloodthinners. A study published in the Journal of the American Medical Association tracked 8,205 U.S. patients who were treated for a heart attack or chest pain known as unstable angina and given Plavix and aspirin. Two-thirds of these patients also took a PPI, primarily Prilosec, and had almost double the risk of having another heart attack or bout of unstable angina compared to those not taking a PPI. Dr. Michael Ho of the Denver VA Medical Center, who led the study, said this drug combination may be responsible for thousands of repeat heart attacks.

Plavix Prescription
Plavix is one of the world's top-selling drugs. Plavix is prescribed with the intention that it may prevent strokes and heart attacks in patients at risk for these problems. Plavix is in a class of medications called antiplatelet drugs. It apparently works by helping to prevent harmful blood clots.

June 2007 - A federal judge permanently blocked a Canadian maker of a cheap generic version of blood thinner Plavix from marketing the drug, saying its version infringed on a valid patent for Plavix. U.S. District Judge Sidney H. Stein said Apotex Inc. had failed to prove that the patent was invalid.

Plavix in Germany
German health insurers, under pressure to cut costs amid reforms, are considering whether to restrict prescription guidelines for Sanofi-Aventis's blood thinner Plavix in a move that could harm the drug's sales. The Joint Committee (B-GA), the self-regulating body of German health insurers is reviewing a report it had commissioned from an independent research institute which questions the benefits of Plavix for certain patients. The German Institute for Quality and Efficiency in Healthcare (IQWiG) said Plavix or Iscover, offered no benefits over aspirin when used alone as a preventative treatment for conditions resulting from arterial diseases. Sanofi-Aventis, the world's third biggest drugmaker, criticised the institute's report.

Plavix update
October 2006 - Bristol-Myers Squibb had third-quarter earnings in 2006 plunge as sales of the anti-clotting drug Plavix were hurt by a cheaper generic. New York-based Bristol earned $338 million, or 17 cents per share, from continuing operations, compared with $964 million, or 49 cents per share, in the year-ago quarter. Plavix was hurt by competition from the early introduction of the cheaper generic by privately held Canadian drug maker Apotex Inc. A deal between Bristol-Myers and Apotex to delay the generic for years fell apart and is now under criminal investigation by the U.S. government for possible antitrust violations. The probe has been widened to review whether the deal violated federal securities laws. Plavix, used to prevent blood clots that can trigger heart attacks, was the world's second-biggest medicine, with global annual sales of $6 billion before the generic arrived.

September 2006 - Plavix has been approved for patients who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI), who are not going to have coronary artery repair (angioplasty). A STEMI is a severe heart attack caused by the sudden, total blockage of an artery. In STEMI patients, Plavix prevents subsequent blockage in the already-damaged heart vessel, which could lead to more heart attacks, stroke - and possibly death. FDA approved Plavix in November 1997 to decrease platelet function in people who suffer from acute coronary syndrome (ACS). Platelets are the sticky blood cells that help to form a clot and can contribute to blocked coronary arteries. According to the American Heart Association, each year an estimated 500,000 Americans have a STEMI heart attack.

August 2006 - A Bristol-Myers Squibb executive entered a secret side deal with a generic drug maker in hopes of preserving a lucrative monopoly over the anti-clotting drug Plavix. Those allegations are thought to be the focus of a Department of Justice investigation of Bristol-Myers and the company’s marketing partner for the drug, Sanofi-Aventis. The court filing, made by lawyers for the Canadian generic drug company Apotex, contends that Bristol-Myers made the secret agreement as part of a proposed patent lawsuit settlement with Apotex. The secret deal, Apotex contends, was an effort to evade the scrutiny of the federal and state regulators who were reviewing the settlement. The filing alleges that Dr. Andrew G. Bodnar, a top assistant to Bristol-Myers’s chief executive, Peter R. Dolan, negotiated the secret deal after regulators objected to an earlier version of the patent settlement on the ground that it would stifle competition. Although the Food and Drug Administration approved Apotex’s generic version of Plavix in early 2006, the settlement would have delayed the introduction of that drug until 2011, several months before the expiration of the Plavix patent.

August 2006 - Canadian drugmaker Apotex Corp. launched a generic version of Bristol-Myers Squibb Co.'s blockbuster Plavix anti-clotting medicine, threatening Bristol-Myers' earnings outlook and dividend.

March 2006 - Sanofi-Aventis shares surged after the French drugmaker settled a dispute with generic rival Apotex Inc. that could keep U.S. patent protection on its multibillion-dollar blood thinner Plavix until 2011.

Plavix or Aspirin?
Plavix is commonly used to prevent blood clots, but is aspirin a cheaper way to prevent a blood clot? Is Plavix being used by doctors mostly because of a major marketing push? Plavix is distributed by Sanofi-Aventis, a French drug manufacturer, and Bristol-Myers Squibb of New York. Plavix is Sanofi-Aventis's top-selling drug.

Plavix Side Effects
Serious side effects of Plavix include bleeding and, rarely, low white blood cell counts or thrombotic thrombocytopenic purpura (low platelet counts with spontaneous bleeding and clotting).

Dr. Sahelian's Opinion
I prefer to stick with aspirin at this time since, in my opinion, Plavix is very expensive and I have not seen enough proof that it is significantly superior to aspirin.

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Posted in: 2009,consumer health,independent health news,natural health care,natural health news,natural news,Nexium,Plavix

Plavix and Nexium Combo Nixed

UPDATE: A 2008 Report on PPI / GERD drugs
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ORIGINALLY POSTED Nov, 2008

Addressing stomach acid and blood thinning are two things that can be treated effectively with natural products including herbs and/or supplements.

Natural treatment is much less costly and won't make millions or billions for the drug companies, and it won't cause gastric bleeding or silent bleeding because of "thin" blood or irritation of the mucosal lining of the stomach or elsewhere.

I don't get the logic behind taking a drug if you know the risk will be gastric ulcers. I don't get why a drug is even prescribed when you know you have to prescribe another drug to try to offset a side effect of the first drug.

I think it would be great if roulette was removed from medical guessing.

Serious side effects of Plavix include bleeding and low white blood cell counts or thrombotic thrombocytopenic purpura (TTP - low platelet counts with spontaneous bleeding and clotting). It sells for about $1.50/pill.

Of course we know how horrified doctors are over Vitamin E because it might cause blood "thinning". Be this at it may, high quality, non-soy vitamin E is an effective natural agent that does protect you from cardiovascular insults. It keeps your blood cells from aggregating and is protective against colon cancer. Vitamin E also helps oxygen cross the alveolar membrane in the lungs and eases menopausal symptoms.

Serious side effects of Nexium may include poor protein digestion, impaired liver detoxification and possibly cancer from long term use. It runs about $1/pill or less.

There are effective natural methods to reduce the 'heartburn' side effects of Plavix without reverting to another pharmaceutical leading to a disastrous drug interaction situation.

See: Healthy Suggestion

Concerns on mixing Plavix, heartburn drugs
By AP Business Writers Matthew Perrone And Marley Seaman

NEW YORK – Stent patients who take the blood thinner Plavix along with certain heartburn drugs may face a greater risk of heart attack, stroke and other dangerous events, according to a study released Tuesday.

Researchers found that patients who were taking Plavix with popular prescription heartburn drugs, including AstraZeneca PLC's Nexium, were significantly more likely to be hospitalized for a heart attack, stroke, chest pain or a coronary artery bypass operation than those who took Plavix alone.

The study followed more than 14,000 patients from 2005 to 2006 in a database kept by pharmacy benefits manager Medco Health Solutions Inc.

Nexium and other proton pump inhibitors, like Wyeth's Protonix, are used to treat chronic heartburn, in which stomach acids come back up the esophagus, causing pain and inflammation. Doctors frequently prescribe these drugs to patients on Plavix because the blood thinner has been linked to a higher risk of ulcers.

Medco said 40 percent of patients in its study were taking the prescription heartburn medications. The company's chief medical officer, Robert Epstein, said that if over-the-counter medications like AstraZeneca's Prilosec were included, the percentage would likely be even higher.

Epstein said heartburn drugs could interfere with a liver enzyme needed to process Plavix, neutralizing its effects.

He stressed that patients should not stop taking Plavix or heartburn drugs, particularly if they have a history of stomach problems.

"But if you're a person who's otherwise healthy taking Plavix, you might want to consider calling your doctor and asking, 'Do I need really need this' or 'Do I need it every day?' " Epstein said in an interview. "There are ways to look at this question now that we wouldn't have thought about previously."

Bristol-Myers also urged patients to talk with their doctor before taking action and questioned Medco's approach.

"While we are still reviewing the data, in general, retrospective analyses — in contrast to randomized clinical trials — are more subject to confounding factors," said spokesman Ken Dominski.

Academics at the the American Heart Association's annual meeting in New Orleans, where the data was presented, had similar concerns.

Dr. Robert Harrington of Duke University said that without a rigorous study comparing patients with similar health profiles "you cannot assume that the groups are balanced" and the results are real rather than a fluke.

For example, he said, people taking proton pump inhibitors may also have other health problems that skew their risk for heart disease.

"I would not change practice based on these data," said Harrington, who led an American College of Cardiology panel that last month said it was reasonable for doctors to prescribe these two drugs together.

All patients in the Medco study had been implanted with a stent, or a wire-mesh tube used to prop open arteries after they have been cleared of plaque. The study tracked whether they had been hospitalized for the heart and circulatory problems within a year of the stent being implanted.

In patients who had not suffered a previous heart attack, 32.5 percent patients who took Plavix and a heartburn drug experienced one of the severe events within a year of their stent surgery. Those events were seen in just 21.2 percent of patients who took only Plavix.

In patients who had suffered a previous heart attack, 39.8 percent of patients experienced the severe events within a year. In patients who did not take the heartburn drugs, only 26.2 percent did.

Plavix, or clopidogrel, is the second best-selling drug in the world, with global sales of $7.3 billion in 2007. It is marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis SA.

Heartburn drugs were the fourth best-selling class of drugs last year, with sales of $25.6 billion, according to IMS Health.
Shares of Bristol-Myers Squibb Co. fell 34 cents Tuesday to close at $20.04. Shares of Paris-based Sanofi-Aventis rose 5 cents to $30.02.

AP Medical Writer Marilyn Marchione contributed to this report from New Orleans.

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Posted in: 2009,blood thinning,drug interactions,heartburn,Nexium,Plavix