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Published on May 19, 2005 by Edgar Snyder

Black-Box Drug Warnings Inadequate

Black Box Warning

Check out your medicine cabinet. Do any of your prescription drugs have a black box on the label? That’s the strongest warning given to medication that could pose more health risks than benefits. Concerned critics raise the issue that the black-box warning isn’t enough and more needs to be done to educate physicians, patients and pharmacists about the potential dangers of prescription drugs identified with the black rectangular warning labels.

Because of limited consultations, the effectiveness of labeling drugs with black-box warnings is debatable, according to pharmacologists and FDA officials. When a dangerous drug receives the strongest warning, typically drugmakers send accompanying printed materials outlining the risks. These ‘Dear Doctor’ letters and consumer friendly MedGuides detail the dangers of prescribing the drugs.

Because the FDA doesn’t have the authority to dictate medical practice, only influence it, the agency has no way to confirm doctors’ understanding of the health risks or how educated the patients are about dangers of prescription drugs.

Recent black-box warnings on antidepressants and non-steroidal anti-inflammatory drugs, including Celebrex, generated a great deal of publicity about the hidden dangers of some widely prescribed drugs. But the effect, if any, that a black-box warning has on doctors prescribing the drugs and patients taking the drugs is yet to be determined.

According to critics, relying on a black-box label and handing a patient a Med-Guide just isn’t enough. Critics believe the FDA needs to be more proactive about educating doctors about the dangers in response to aggressive drug company marketing. So far the FDA has not changed their notification process.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Ohio, and West Virginia and we associate with experienced attorneys in other states. In addition, all drug-related litigation involves co-counsel.

Source: “Drug warnings outline danger.” By Rita Rubin. USA Today. May 18, 2005.
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