To Black Box Or Not To Black Box

Patients need to know that a particular class of antibiotics can cause ruptures of tendons, such as, the Achilles tendon, the rotator cuff (shoulder), the biceps, the hand, and the thumb. The drug companies say that deep within the printed package insert is a warning of this risk. Public Citizen is petitioning the FDA to require a black box warning. Seems like a good idea to me.

Some Antibiotics Linked To Tendon Rupture; Public Citizen Petitions FDA For Stronger Warnings

The consumer advocacy group Public Citizen filed a petition with the FDA in late August 2006 requesting that the agency order drug companies to put a “black-box” warning about the risks of tendon rupture that have been associated with a class of antibiotics known as fluoroquinolones. Some of these antibiotics are Bristol-Myers Squibb’s Tequin, Ortho-McNeil’s Levaquin, and Bayer’s Cipro.

According to an August 29, 2006 Associated Press article at least one of the affected drug companies thought the current label was adequate:

Levaquin’s label already “clearly states” tendon rupture can occur during or after treatment with the antibiotic, said Ambre Morley, a spokeswoman for Ortho-McNeil Inc., the Johnson & Johnson subsidiary that makes the drug.

Jennifer Corbett Dooren, of Dow Jones Newswire, reported why Public Citizen disagreed with that position in a piece published by The Wall Street Journal on August 29, 2006:

The drug labels do warn of the risk of tendon ruptures but the warning is not contained in a black-box, which is considered the FDA’s toughest warning. A black box warning is in bold type and is surrounded by a black box to make it stand out. It typically appears at the top of drug labels and any advertising of products that carry black boxes must also include warning information as part of the advertisement.

Public Citizen said the tendon warning is buried in a list of possible adverse reactions to the drugs and is not adequate to warn consumers and health-care providers of the risk. The current tendon warning was added after Public Citizen petitioned the agency asking for such a warning in 1996.

Excerpted from Drug Injury Watch.