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FDA drops plan for prescription drug watch list
2007-03-03
Health officials said on Friday they had dropped plans to keep a public list of prescription drugs with emerging safety concerns, one of the measures proposed after Merck & Co.'s 2004 withdrawal of its arthritis drug Vioxx. Instead of a "Drug Watch" list, the Food and Drug Administration will place red asterisks next to the names of the medicines on an existing Web page that lists dozens of prescription drugs. Consumers can click on the drug name to link to FDA advisories and other information. "I feel strongly that such an approach meets our goal" of providing useful information to doctors and patients, Dr. Paul Seligman, associate director for safety policy and communication in the FDA's drug center, told reporters. The FDA made the change because there was concern about potential confusion between "Drug Watch" and "MedWatch," an FDA program that provides alerts about new information on medical products, Seligman said. Details on various drugs can be found at http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm. Consumer watchdog Dr. Sidney Wolfe said it sounded like the information would be hard for consumers and doctors to find, noting that they would need to scroll through a long list. "If a busy physician seeing patients has to spend more time finding it, they are going to be less likely to use that Web site," said Wolfe, director of Public Citizen's Health Research Group. Drugmakers are pleased the FDA abandoned Drug Watch and was embracing a more balanced approach, said Alan Goldhammer, associate vice president for science and regulatory affairs at the Pharmaceutical Research and Manufacturers of America industry group. The new plan "looks at the whole spectrum of information on both drug benefit and risk. That's been one of the points we've tried reinforcing - that one can't look at risk in the absence of benefit," Goldhammer said in an interview. The Drug Watch proposal was one of several the FDA issued following Merck's withdrawal of Vioxx when research showed the arthritis medicine doubled heart attack and stroke risk in people who took it for at least 18 months. The FDA also created a drug safety oversight board and began releasing early information about possible side effects to the public. Critics said the FDA was slow to react to signs of problems with Vioxx and other prescription drugs.
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