The move comes after a recent clinical trial linked the arthritis drug to these potentially fatal conditions. The company says trial data show an increased risk of heart attack and other cardiovascular problems began 18 months after patients started taking Vioxx. The study did not show any increased risk of confirmed problems in the first 18 months.
The three-year study of 2,600 people was initially targeted to show that Vioxx at a 25-milligram dose prevents recurrence of polyps in the colon and rectum. But it was stopped early after Merck discovered a higher risk of heart attack and stroke associated with the medication.
"We are taking this action because we believe it best serves the interests of patients," says Raymond V. Gilmartin, Merck's chairman, president, and chief executive officer.
This is not the first time there has been evidence linking Vioxx to heart attack. A study earlier this year showed that patients taking more than 25 milligrams a day had triple the risk for heart problems. Another study showed that Vioxx doubled the risk of heart attack in patients taking blood pressure medication.
Vioxx has been one of Merck's blockbuster drugs in a class of Cox-2 inhibitors, which are used to relieve arthritis and joint pain.
Merck says patients who are currently taking Vioxx should contact their health care provider to discuss discontinuing Vioxx and possible alternative treatments. Patients and health care providers can obtain more information by calling (888) 36-VIOXX (1-888-368-4699).
"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," says acting FDA Commissioner Lester M. Crawford, MD, in a news release.
"Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall,patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."
The FDA says it will closely monitor other drugs in this class for similar side effects. "All of the NSAID [non-steroidal anti-inflammatory] drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician," says Crawford.
SOURCES: Wire reports. WebMD Medical News: "More Evidence Vioxx Increases Heart Risks." News release, Merck. FDA.
My now 30-year-old, ex-boyfriend, Mohammed, was on this drug (he may still be) for a side effect of ulcerative colitis (that was a dreadful ordeal in itself). Because of his age, I don't suspect he'd be at risk for these things yet...but one never knows.
I have a real problem with running to medications that are relatively new to the market. I understand drugs go through much research and clinical studies, but my problem is with the long-term effects. The turnover rate for new drugs on the market from competitors will not allow for ten, or even five year test trials. So, even the drug-makers do not know the long term effects.
In Mohammed's case, if he didn't take the drug daily, his knee would swell up so bad, it would seep. I wonder if he still had that problem, and if so, hat's he going to do? He tried Celebrex to no avail. He was on Prednisone, but that really shouldn't be taken for prolonged periods, either. So what are the people who rely on drug going to do now? I wonder if people taking Vioxx that did have a heart attack or stroke are going to sue Merck now? Just like what happened with Phen-Fen.....
Are we a nation too consumed by miracle drugs and pharmaceutical companies? My mom has been a nurse for over 40 years. Now she works for a For-Profit Surgery Center, which means they get many, many visits from drug reps peddling their pills. They also get free lunches for the entire staff from these reps. Not to mention all the little doo-dads that they just hand out...pads of paper, pens, mugs, magnets, etc. I wonder why we pay more for drugs than other countries?!?! I feel for those who use this drug and now have nothing to turn to......