FDA to Provide Emerging Drug Safety Information
The FDA has issued a new guidance that addresses the scarcity of information about the safety of prescription drugs after they are approved.
?All drugs have risks, and health care professionals and patients must balance the risks and benefits of a drug when making decisions about drug therapy,? according to the guidance. After a new drug is approved, the FDA reviews the data and evaluates potential safety concern. If there is a safety issue, FDA scientists immediately review and analyze data. The problem is the period of uncertainty during the period of evaluation.In 2004, Merck voluntarily recalled Vioxx, a pain medication, after problems surfaced showing that the drug increased the risk of heart attack and stroke among people who took it for at least 18 months. The FDA received harsh criticisms for its slow reaction to signs of problems with Vioxx and the scarcity of reliable information about such problems.In light of Vioxx, the FDA initially planned to establish a new Web site to be called Drug Watch, which will serve as an early-warning system for adverse events. However, pharmaceutical companies feared that people will confuse Drug Watch with MedWatch, the FDA's safety information and adverse-event reporting program that allows health-care professionals and the public to report serious problems associated with medical products. The industry was also concerned that any premature information would scare patients.Consequently, the FDA has abandoned its plan to launch Drug Watch. Instead, it will utilize the existing ?Index to Drug-Specific Information? section of the FDA's Web site for communication about serious side effects. The FDA will put a red asterisk next to names of medicines with any emerging safety information. A patient or a health-care provider can then click on the drug name to get to links to FDA advisories and other information.
Consumer advocates, such as the Public Citizen's Health Research Group, are unhappy about the FDA's decision to abandon the plan for Drug Watch. But the Pharmaceutical Research and Manufacturers of America (PhRMA) supported the FDA's initiative. ?It is crucial for FDA's drug safety alerts to strike a proper balance between protecting safety through the timely dissemination of information and promoting public health by ensuring continued access to potentially life-saving medicines,? said Alan Goldhammer, PhRMA deputy vice president for regulatory affairs.
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