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Friday, March 13, 2009

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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