New warnings added to US group's drug safety site

Consumer watchdog group Public Citizen expanded its drug safety Web site worstpills.org on Wednesday to include more warnings about side effects, drug interactions and inadequate research.

The safety warnings and recommendations on more than 500 products include 181 drugs that Public Citizen says patients should not use despite U.S. Food and Drug Administration approval.

Neither "the FDA nor the industry are putting out really accurate information," said Public Citizen's Health Research Group Director Dr. Sidney Wolfe, who in the past has cautioned about drugs before they were withdrawn or required additional safety label warnings.

The worstpills site expansion follows several months of warnings by companies and regulators about prescription and over-the-counter painkillers that were shown to increase the risk of heart attacks and strokes.

Merck & Co. Inc. pulled its arthritis drug Vioxx from the market in September. Last month the National Institutes of Health halted two studies involving Pfizer Inc.'s Celebrex and naproxen, sold by Bayer AG under the brand name Aleve.

The FDA has also cautioned patients and doctors to limit their use of such drugs and will hold a meeting next month to discuss them.

Wolfe said his group first noted concerns over Vioxx in 2001 and included them in earlier versions of the book.

Of the 181 drugs, which include Vioxx, Pfizer painkillers Celebrex and Bextra are a top concern, Wolfe said. The group plans to petition the FDA as early as next week to remove both drugs from the market, he said.

Court Rosen, spokesman for the industry group Pharmaceutical Research and Manufacturers of America, said patients were welcome to research their medicines but should not stop taking a drug without talking to their doctors.

Rosen added that the FDA was "the best in the world" at evaluating medicines and that patients should be confident that their drugs are safe.

But Wolfe said that that is not always the case. "Drugs that shouldn't get on the market, get on the market" and others that show problems after approval continue to be sold, he said.

Doctors and patients are also misled by direct-to-consumer advertising that downplays side effects, and they need another place to get warning information, Wolfe added.

About 100,000 Americans die each year from drug reactions, and most are preventable, Wolfe said.

Patients who don't subscribe to the Web site can still find basic warning information, he said. Users can also look up side effects and find medicines that can cause them.

The site has information for the first time on dietary supplements, including black cohosh, ginseng, saw palmetto and 10 others - all of which the group cautions against using to treat medical conditions.