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. Plavix is the world's second
biggest-selling medicine, with worldwide sales of around $9 billion, while
Nexium revenues totalled $5.2 billion in 2008.
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
Plavix, also known as clopidogrel and sold by Sanofi and Bristol-Myers
Squibb, is widely used with proton pump inhibitors, or PPIs, including
AstraZeneca's Nexium and Prilosec to cut the risk of gastric problems.
In one study, 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.
Heartburn pills like Nexium and Prilosec stop blood-thinning
drugs such as Plavix from working effectively.
The Food and Drug Administration said in November 2009 the
stomach-soothing drugs Prilosec and Nexium cut in half the
blood-thinning effect of Plavix, 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 OTC is available over-the-counter,
while AstraZeneca's Nexium is only available with a prescription. 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.
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 but most likely not.
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.
Plavix
medication questions
Q. I had a carotid operation for plaque and have been on Plavix 75
mg since then. i have several diabetic related symptoms for which I take
various supplements such as Omega 3, Vitamin E, garlic, etc. Is there a
danger of bruising or bleeding? How do I keep taking the supplements
without subjecting myself to excessive bleeding or bruising possibility?
A. Several supplements decrease coagulation of blood,
and so does Plavix. It is the responsibility of your physician who
prescribes the Plavix to discuss this matter to you in order to avoid
excessive bruising or bleeding. There is a possibility that a lower dose
of Plavix may be needed if individuals consume certain herbs or more
flavonoids. and plant substances.
Q. I have
been taking a MSM supplement for many years. However, recently I have been
placed on Plavix. Is it safe to take a MSM supplement with Plavix
medication?
A. We have not seen any studies with Plavix in combination with MSM,
nor have we seen human studies regarding the role of MSM on blood clotting
and platelet function. Caution is advised when supplements and medications
are combined since unexpected reactions could occur. Your doctor should be
aware of the dietary supplements that you are taking in regards to the
additions of prescription medications.
Q.
Two years ago I had an angioplasty procedure and 3 medicated stents
inserted. I am currently taking 75 mg of Plavix plus
91 mg aspirin daily to prevent blood clots - have been told clots are more
likely to occur with medicated stents. I bruise terribly at the slightest
touch and am concerned about Plavix side effects. Also, the price is
almost out of my reach and a definite hardship; I am 84, in otherwise
fairly good health, am taking Rx for hypertension. What is your opinion of
Plavix plus aspirin, vs aspirin therapy alone? I am now cutting my Plavix
in half because of the cost. I would appreciate any comments you could
make to guide me. Should I look into ordering Plavix from Canada?
A. It is not possible to predict in any one individual, without a
full examination and review of history and blood studies, to know whether
Plavix is helpful, whether Plavix is better than aspirin, or whether
aspirin alone or natural supplements such as fish oils are a better
option. You may wish to review this page on Plavix and come to an
agreement with your doctor on the best course of action for your unique
situation.
Q. Is there any reason I shouldn't take Wobenzym enzyme supplement with
Plavix,or possibly in place of? I presently take 75mg once a day since I had a
stroke in April of 2007. I am 68 years old and do not have a weight problem or
poor health in general.
A. The decision to take any supplements along with Plavix or any
medication rests with you and your doctor. I have not seen studies regarding the
blood thinning potential of Wobenzym and certainly no studies that have combined
Wobenzym and Plavix together.
I am taking
Plavix because I have 4 small stents in one artery and I gather that there is
increasing evidence that this drug, while thinning the blood, also contributes
to arteriosclerosis, calcification of the arteries and the aorta. I am also told
that vitamin k2 helps with this. Do you have information on the advisabilty of
taking vitamin k2, or natto, while taking Plavix?
No, I don't. Each person and their overall health and medical
condition has to be individually and comprehensively evaluated to make the
decision on which medications to take, in what dosages, combinations and use
with supplements.
I have a quick
question about what is your sincere opinion about Plavix? My Mom (53) almost
have a thrombosis by blood clots in her right leg, and doctors prescribe for her
this drug I am very concern about the side effects of this drug. I think I will
prefer warfarin for this one been used for more time. Can you please help me
with your advise?
I can't offer specific advice but hopefully the research on
this page can guide you.