FDA’s Black Box Warning: Too Little, Too Late for Levaquin Users?
In July 2008, the FDA requested that the manufacturers of Fluoroquinolone drugs include a black box warning on their packaging to inform patients of the connection between the drug’s use and the risk for tendon ruptures. Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, was therefore required to include such a warning on its Fluoroquinolone antibiotic Levaquin.
What is an FDA Black Box Warning?
An FDA black box warning is the most serious type of warning that the FDA can require a drug manufacturer to put on its packaging of a pharmaceutical drug. Black box warnings are typically reserved for drugs that have a significant risk of serious or fatal side effects. A black box warning is required to be included on the package insert. It has a black box around the text in order to alert patients to its importance.
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Why Did the FDA Request a Black Box Warning for Fluoroquinolone Antimicrobial Drugs?
The FDA requested the black box warning because of the increased risk of tendonitis and tendon rupture for patients taking Fluoroquinolone Antimicrobial Drugs such as Levaquin. The FDA found that despite the drug manufacturers’ attempt to warn patients about the risks of tendon injuries, large number of tendon injuries and ruptures were reported to the FDA that were caused by Fluoroquinolone drug use. Therefore, the FDA found it necessary to increase the visibility of the warning and to make doctors and patients aware of the potential serious side effects of these drugs.
Did the FDA Take Any Other Action?
The FDA also required the drug manufacturers to include a Medication Guide with each prescription of Fluoroquinolone Antimicrobial Drugs. The Medication Guide is intended to give patients more information about the risks involved with taking Levaquin and similar medications.
Further, the drug manufacturers were notified that a Risk Evaluation and Mitigation Strategy (REMS) would be necessary in order to determine if the benefits of the drugs still outweighed the risks associated with the drugs.
Did the FDA Act Quickly Enough?
It took more than a decade for the FDA to issue a black box warning regarding Levaquin and similar drugs. There has been public pressure on the FDA to increase the warnings associated with Levaquin and similar drugs since at least 1996. In 2005, the Illinois Attorney General filed a petition with the FDA seeking a black box warning. Many Levaquin patients were hurt by tendon ruptures in the years before the FDA finally took action and patients have continued to be harmed by the drugs in the months following the FDA’s actions.
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Any patient who has suffered a tendon rupture from Levaquin use should consult with a pharmaceutical litigation attorney for additional information.
