Arthritis drug recalled

0 Comments | La Crosse Tribune, Oct 01, 2004 | by Rindfleisch, Terry

La Crosse-area physicians and pharmacists advised patients Thursday to talk to their doctors and stop taking the arthritis drug Vioxx, which was voluntarily withdrawn from the market.

Pharmaceutical giant Merck & Co. announced Thursday it was halting worldwide sales of Vioxx, once viewed as possibly being able to prevent some cancers, because new data from a clinical trial found an increased risk of heart attack and stroke.

Dr. Charles Cagin, a Mayo Clinic cardiologist at Franciscan Skemp Medical Center, said the data showed an increased risk of heart attack and other cardiovascular complications began 18 months after patients started taking Vioxx.

Cagin said Merck was conducting a three-year study aimed at showing Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. Such polyps can turn cancerous. The trial was stopped after Merck discovered study participants had an increased risk of a heart attack, compared to other participants taking dummy pills.

Dr. Gary Bryant, a Gundersen Lutheran Medical Center rheumatologist, said patients who used Vioxx should talk to their physicians about using substitute medications. Bryant said other drugs similar to Vioxx, which are in a class called cox-2 inhibitors, are equally effective, but patients should discuss the choices with their physicians to weigh the benefits and side effects.

He said Vioxx was prescribed because it had fewer side effects, such as ulcers and stomach bleeding, but studies had been questioning the drug's connection to an increased risk for heart attack and stroke for the past several months.

Bryant said the medical center's pharmacy and therapeutics committee was considering recommending Celebrex and Bextra. as preferred drugs over Vioxx due to an uneasiness over heart risks.

"We had been watching this closely, but I was blown away by the company's voluntary withdrawal of the drug," he said.

Bryant sent an e-mail to all Gundersen Lutheran physicians and pharmacists Thursday about not prescribing Vioxx. Patients have been calling and wanting to know what to do, he said.

Merck has a successor drug called Arcoxia, approved in some other countries and awaiting Food and Drug Administration approval in the United States. Cagin said patients should discuss using Pfizer's Celebrex and Bextra, but the Food and Drug Administration reported it will closely monitor similar drugs for cardiovascular side effects.

Vioxx, Celebrex and other nonsteroidal anti-inflammatory medications all have potential risks such as fluid retention, high blood pressure and kidney complications, but Cagin said it is unclear what has caused the increased risk for heart attacks and strokes.

"All have some degree of risk for acute coronary events, but Celebrex is less risky, and Tylenol (acetaminophen) is good, but it's underprescribed and underused," Cagin said.

In terms of pain relief, cox-2 inhibitors are are no better than ibuprofen, Cagin said.

About 2 million people worldwide are currently taking Vioxx, according to Merck, and a total of 84 million have taken it since it came on the market with great fanfare in 1999. Merck recorded its biggest stock market tumble in at least 20 years on Thursday, plunging $12.07 a share to $33 a share. The company generated $2.5 billion in Vioxx sales last year.