Share this article:
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
Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Features

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Is your marketing strategy stuck in 2005?

Is your marketing strategy stuck in 2005?

It is not enough to just have a killer black book or Rolodex. The market needs agile, swift marketing

Is guidance stifling social media?

Recent FDA draft guidance was meant to help companies create FDA-compliant tweets and handle third-party misinformation on the web. What other obstacles lie in the path of effective social media use?

FDA social media guides draw flak

FDA social media guides draw flak

Two FDA guidance documents on how health product manufacturers may participate in social media have drawn criticism from industry and consumer groups.