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 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 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.