FDA Orders Cipro to Carry Black Box Warning
July 8, 2008
On July 8, 2008, the U.S. Food and Drug Administration (FDA) imposed the government’s most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated, needing extensive surgery and months of rehabilitation. Specifically, the FDA ordered makers of flouroquinolones, a potent class of antibacterial drugs, to add a prominent “black box” warning to their products and develop new literature for patients emphasizing the risks.
Tendon ruptures are normally thought of as sports injuries and generally occur among men in their mid-thirties. Cases of tendon ruptures linked to treatment with Cipro are highly unusual, and scientists still don’t fully understand why it happens. However, FDA officials stressed that many of the serious injuries appear to be preventable if patients stop taking Cipro at the first sign of pain or swelling in a tendon, call their doctor, and switch to another antibiotic.
The two leading drugs covered by the warning are Cipro, which is made by Bayer, and Levaquin, which is made by Ortho-McNeil. Cipro became a household name when it was prescribed to thousands of patients during the anthrax attacks of 2001. It is effective against deadly bacteria, and is among the medications stockpiled by the government in case of a bio-terror attack. In everyday medicine, Cipro is often used to treat urinary tract infections. Levaquin is generally used to treat respiratory infections.
The recent FDA health alert regarding Cipro and tendon ruptures was issued in response to a lawsuit filed against the FDA in January 2008. The lawsuit, filed by a consumer advocacy group called Public Citizen, sought to compel the FDA to order Cipro’s maker to include a warning on the Cipro label regarding the risk of tendon ruptures and other tendon injuries. According to the lawsuit, tendon ruptures linked to antibiotics, like Cipro, continue to occur at a disturbing rate. Additionally, the lawsuit alleged that many tendon ruptures could be prevented if doctors and patients were aware of the early warning signs associated with tendon ruptures.
Legal Help for Victims of Cipro Injuries
If you or a loved one took 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.