July 14, 2008
Regular readers of this column know that one of my major themes is to defend lifesaving effective drugs that are wrongly targeted in the media. Readers also know that, although I am on the lookout for side effects, that I never complain as much as when a concern is overhyped and turns into a health scare.
But one phenomenon that has grown in the past few years is FDA black-box warnings. Fearing a media bashing over a certain drug, the FDA often issues a stern warning in advance of public exposure, in response to consumer advocate pressure.
In this case, the consumer group Public Citizen asked the FDA in 2006 to put a black-box warning on Cipro and other fluoroquinolones (including the popular Levaquin and Avelox). And this year, Public Citizen filed a lawsuit to try and force the FDA to take these actions. According to the FDA, fluoroquinolones can increase the risk of tendon inflammation and rupture from 1 in 100,000 patients to 3 or 4 in 100,000 patients.
But this increased risk is miniscule when you consider the number of lives Levaquin or Cipro save in patients with pneumonia, infectious colitis or serious urinary tract infections. Although black-box warnings won't prevent me from prescribing these well-tolerated drugs, they will scare patients and make them reluctant to take these pills without statistical cause to be worried.
Medications should be prescribed on a case-by-case basis and should be based on reason rather than emotion.
But what doesn't make sense is to avoid perfectly good drugs based on an over-inflated sense of risk based on fear. Unfortunately, once again this seems to be the direction we as health providers and consumers are taking.
Marc Siegel, MD, is an internist and associate professor of medicine at New York University and the author of False Alarm: The Truth About the Epidemic of Fear