FDA Recommends Black Box Warning for Levaquin and Cipro
July 8, 2008
The U.S. Food and Drug Administration (FDA) today ordered the makers of certain antibiotics to add a black box warning to their labels alerting patients of possible tendon ruptures and tendonitis. Additionally, the FDA announced it will ask the same drug makers to create a Medication Guide, which will be given to patients and will alert them about possible side effects.
Cipro and Levaquin belong to the group of antibiotics now required to carry a black box warning, which are known as fluoroquinolones. Fluoroquinolones are sold by several drug makers under a variety of brand and generic names. Although the antibiotics’ labels warn of the risk of tendon ruptures, none include black box warnings.
A “black box warning”, which is the FDA’s strongest label warning, is in bold type, surrounded by a black box to make it stand out. Typically, black box warnings appear at the top of drug labels. Any advertising of products that carry black box labels must also include the black box warning information as part of an advertisement.
The movement to add a black box warning to antibiotics, such as Levaquin and Cipro, began in 2005 when the Illinois Attorney General and a consumer advocacy group called Public Citizen petitioned the FDA to place a black box warning regarding the risk of tendon ruptures on these drugs’ labels. In Public Citizen’s FDA petition, the director of Public Citizen’s Health Research Group stated that tendon ruptures linked to antibiotics, like Levaquin and Cipro, continue to occur at a disturbing rate. The petition also alleged that many tendon ruptures could be prevented if doctors and patients were aware of the early warning signs associated with tendon ruptures.
Because the FDA did not order a black box warning in response to Public Citizen’s petition, Public Citizen filed a lawsuit against the FDA in an attempt to compel the agency to order a black box warning regarding the risk of tendon ruptures and other tendon injuries in patients taking certain antibiotics, like Levaquin and Cipro. Finally, in July 2008, the FDA issued a health alert notifying the manufacturers of certain antibiotics, including Levaquin and Cipro, of the need to add a black box warning to prescribing information about the increased risk of developing tendonitis and tendon rupture in patients taking fluoroquinolones.
Injured by Levaquin or Cipro?
If you or a loved one took Levaquin or Cipro and experienced a serious side effect, such as a tendon rupture, contact us today as you may be entitled to compensation for your injuries.
- Bernstein Liebhard is no longer accepting Cipro cases.