Complain about a product or service

Vioxx May Have Caused 140,000 Heart Attacks

January 26, 2005

Audio Version

Food and Drug Administration safety reviewer David Graham estimates that Merck's Vioxx may have caused as many as 140,000 heart attacks in the U.S. before it was withdrawn last September. His estimate was published in the British medical journal Lancet.

Related Stories • Pfizer Pays Record $2.3 Billion Settlement Over Illegal Marketing Charges • Court Snuffs Vioxx Suit • Pfizer Pays $894 Million to Settle NSAID Claims • Researchers Claim Vioxx Safety Study Was Actually Marketing Plan • First Vioxx Judgment Overturned On Appeal • Merck Agrees to Pay $58 Million to Settle Vioxx Claims • Researchers Claim Merck Cooked Vioxx Data • Common Pain Relievers May Boost Muscle Mass • More Painkillers Can Cause More Pain • Merck Caves, Agrees To $4.85 Billion Vioxx Settlement • New York Sues Vioxx Maker over Drug’s Risks • Merck Wins Vioxx Case In Illinois • Judge Rules Out Vioxx "Super" Class Action • FDA Critic Blasts Merck's Vioxx Replacement • Merck Loses New Orleans Vioxx Case • Merck Wins Latest Vioxx Suit • Vioxx Study Authors Backtrack On Claim • Older Painkillers May Increase Heart Attack Risk • More about Vioxx --- Other NSAIDs • Bextra • Celebrex • Dangers of Other Vioxx-Type Drugs • Vioxx Alternatives • Aleve Ingredient Seen as Health Risk

The study was based on records of 1.4 million members of Kaiser Permanente, the largest U.S. nonprofit insurer, with 6 million members in California. Many of the cases may have been fatal, Graham said.

A Merck spokesman said the estimate of harm from Vioxx was "speculation." Determinations of Vioxx's potential role in patients' cardiovascular problems "can only be made on a case by case basis," he said.

The publication of Graham's findings is expected to intensify the drug-safety debate that has swept Washington since the Vioxx withdrawal. Graham and other critics accuse the FDA of being too slow to ban or tighten regulations on medicines that cause serious side effects.

Researchers compared the incidence of heart attacks and sudden cardiac death for patients taking Vioxx with those on Pfizer's Celebrex, a similar painkiller, and over-the-counter medications.

Applying the findings across the U.S. population, "We arrived at the estimate of 88,000 to 140,000 patients that had a heart attack in the U.S. because they used Vioxx" after it was introduced in in 1999, Graham said.

Portions of the study had been disclosed earlier. Graham said in Nov. 18 testimony before the Senate Finance Committee that between 88,000 and 139,000 heart attacks may have been linked to Vioxx.

Merck withdrew Vioxx after a company study showed that patients taking it for 18 months or longer had twice the risk of heart attacks and strokes -- 1.5 percent -- as those taking a placebo.

Graham said his bosses at the FDA at one point threatened to fire him as associate director for science and medicine in the agency's Office of Drug Safety if he published the findings.

The study found that Vioxx, given at the standard dose, increases the risk of heart attack by about 50 percent, compared with Pfizer's Celebrex, and more than triples the risk of heart attacks when given at high doses. The two drugs suppress the body's production of the Cox-2 enzyme, which is linked to pain and swelling.

People taking Vioxx had a 34 percent higher chance of heart disease compared with those taking other painkillers including Celebrex, naproxen and ibuprofen, the study found.

Patients taking naproxen, a generic painkiller sold as Aleve by Bayer AG, had a 14 percent increase in heart risk compared with some other painkillers such as ibuprofen, the study showed. Previous trials had suggested naproxen may protect against cardiac disease.

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Share		Follow us on Twitter.

Back to the top |