Vioxx-Linked Heart Attacks May Occur Within 2 Weeks, Study Says

Merck & Co.'s Vioxx painkiller may raise the risk of a heart attack within two weeks after patients start taking the drug, earlier than previous studies have shown, according to Canadian researchers.
More than a fourth of 239 elderly patients who had heart attacks while on Vioxx did so within six to 13 days after they first started taking the drug, according to a study published online today by the Canadian Medical Association Journal.
Merck, which faces 11,500 Vioxx lawsuits, argued throughout recent trials that short-term use of the drug doesn't cause heart attacks. The company has been hit with three jury awards totaling $298.3 million, two of which involved short-term use of the painkiller. In the most recent trial, a jury on April 21 awarded $32 million to a Texas family after finding that Vioxx caused the death of a man who took it for about a month.
``For first-time users you can have an event in as little as two weeks,'' said Linda Levesque, assistant professor of epidemiology at Queen's University in Kingston, Ontario, and the study's lead researcher, in an interview today. ``Now we have evidence that early risk is possible.''
Merck spokeswoman Casey Stavropoulos couldn't comment immediately.
Merck, the fourth-biggest U.S. drugmaker, withdrew Vioxx in 2004 when a study showed it doubled the risk of heart attacks and strokes after 18 months of use. The company, based in Whitehouse Station, New Jersey, has set aside $970 million for legal costs and nothing for damages, vowing to fight each case rather than settle out of court.
`Cases Easier to Win'
Attorney Mark Lanier, who won two of the three trial victories over Merck, said the study will ``absolutely'' help in cases against Merck.
``It's going to make short-term cases easier to win,'' Lanier said. He said the Canadian findings are ``consistent with the medicine we've been talking about and all of the science except that which is funded by Merck.''
Canadian researchers analyzed health records of 114,000 patients ages 66 and older who were prescribed painkillers, including Vioxx, Pfizer Inc.'s Celebrex and ibuprofen, a non- prescription pain medication.
While about 30 percent of the patients had risk factors for heart disease, such as hypertension or coronary artery disease, none had ever had heart attacks. The study, which followed patients for about two and a half years, included 30,200 Vioxx users and 45,000 Celebrex users.
No Celebrex Link
Out of the 239 heart attacks, 65 occurred within a median of 9 days the after patients started taking Vioxx, researchers said. The study found no such statistically significant increase in risk among patients taking Celebrex.
The study also found that the risk of a heart attack associated with Vioxx didn't increase with the length of treatment and diminished after patients stopped taking the drug.
``Hopefully the study will contribute to better decision- making and put peoples' minds at ease for those who stopped the medication and may be wondering how long they have to worry,'' Levesque said.
Plaintiffs' attorneys have argued to jurors that Merck's unpublished data from clinical trials and other data show an increased risk of heart attacks after short-term Vioxx use, a claim sharply contested by the drugmaker.
``Our analysis of Merck's clinical trials shows that people have heart attacks even with short-term use of Vioxx,'' said attorney Christopher Seeger, whose firm of Seeger Weiss LLP has filed nearly 500 Vioxx suits. ``Merck has been spinning its data to show there is no risk until 18 months.''