Plavix: Cause for Concern

New York, NYSandra Cornell was prescribed Plavix in May 2006. Two weeks later, she started getting "palpitations", a known side effect of this drug, but Cornell (a retired registered nurse) had the wherewithal to recognize that they were premature ventricular contractions (PVC's).

"Although I am a medical person, this scared the hell out of me," said Cornell. "After 16 days on Plavix, (known generically as clopidogrel) I called my cardiologist and told him I was having PVCs like nothing I had ever experienced before. As well, I had severe stomach pains and symptoms of internal bleeding (blood in my stool). He put me on a high-powered anti-acid for my stomach problems and I stopped taking Plavix.

"The PVCs continued periodically for the next several weeks - I am so lucky (and thanks to my nursing experience) to have taken myself off this dangerous drug. Some people may not recognize the warning signs; they may not have access to the Internet for updates on Plavix - people are saying that their doctors don't know what the side effects are and that is a cause for concern.

For every one person who knows that Plavix could cause a stroke or heart attack, there could be 10 or 20 people who are still taking Plavix and the results could be a lot more severe than what I went through."

In 1997, Plavix received FDA approval to thin the blood and prevent clots that can block arteries. Doctors started prescribing Plavix, along with aspirin, to patients like Cornell who had risk factors for heart disease but who had never had a heart attack or stroke. The FDA also warned of serious side effects including bleeding and, rarely, low white blood cell counts and low platelet counts with spontaneous bleeding and clotting. It did not warn of heart attacks or strokes.

But in March 2006 the Associated Press reported that Plavix, when taken with aspirin, actually doubles the risk of death, heart attack, or stroke in patients who have no previous history of heart disease, but have high blood pressure and high cholesterol. Adding Plavix made little difference for the group as a whole except for slightly reducing hospitalizations. But for the 20 percent with no signs of heart disease, the drug combination proved dangerous. Heart-related deaths almost doubled, from 2.2 percent of those taking only aspirin to 3.9 percent of those who added Plavix.

A study published in The New England Journal of Medicine (April 2006) found that the drug was of no help in preventing a first heart attack among at-risk patients. Furthermore, it found that Plavix offered no benefit over standard low-dose aspirin therapy, and it significantly increased the risk of internal bleeding, a complication that can be life threatening.

The only people even modestly helped by adding Plavix were those with established heart disease. Their risk of heart attack, stroke or death was about 7 percent versus 8 percent for those taking aspirin alone. Specialists said this was not enough to justify recommending the drug in light of the overall findings of no benefit.

Why, with knowledge of this recent study, did the FDA approve expanded use for Plavix just months later? Coincidentally, the expanded approval came as Bristol-Myers and Sanofi-Aventis sought a court injunction to block Canadian drug company Apotex Corp. from selling a less expensive, generic version of Plavix. (Canadian generics firm Apotex received an approval from the FDA to launch a generic version of Sanofi-Aventis and Bristol-Myers Squibb's Plavix - bad news for these pharmaceutical giants.)

In 2005, Plavix (which can cost up to $4 per pill) was the world's second highest selling pharmaceutical with sales of US$6 billion worldwide for Sanofi-Aventis and Bristol-Myers Squibb.