The Food and Drug Administration issued a black box warning, the most “urgent” warning they can give, on a class of antibacterials called flouroquinolone drugs. This includes Cipro and other antibiotics. The FDA cites evidence that using these drugs can lead to tendon ruptures, which can leave patients in need of extensive surgery.
Cipro is made by Bayer, while Ortho-McNeil markets the drug under the name Levaquin. Cipro is an effective drug against the effects of the anthrax bacteria, and is stockpiled by local governments in case of a biological terrorist attack. It became well-known in the media during the fall of 2001 during the anthrax scare. It is also used to treat urinary tract infections. Levaquin is used to treat respiratory infections.
Two Years Late
Public Citizen, a consumer group, petitioned the FDA two years ago to ask for this kind of warning. FDA action came only after Public Citizen sued. However, Sidney Wolfe, head of Public Citizen’s health section believes that action came too late and that many of the tendon rupture injuries could have been avoided had the FDA acted sooner. The FDA counters that there is already a warning in the prescription literature about tendon rupture, but acted due to doctors and patients not getting the message. Wolfe believes that, in addition to issuing a warning, the FDA should require the makers of the drugs to send letters to the doctors about the risks. The FDA thinks this should be voluntary and that the manufacturers can send them on their own.
Wolfe claims that 407 tendon ruptures had been reported by the end of 2007, and that there were an additional 341 reports of tendonitis after using the drugs. The FDA says they have received “several hundred” reports of ruptures but have not cited a specific number.
Tendon ruptures are more common with sports injuries occurring to men in their mid-30s. Scientists are unsure why the tendon ruptures occur while taking the antibacterials, and believe the link is “highly unusual.” Those patients who have the highest risk of tendon ruptures include people over 60-years-old, those with heart and lung, and kidney transplants, as well as those taking steroids. Some of the ruptures also came without warning. There was simply a snap or pop after the patient started using the drugs. The FDA believes that flouroquinolone may be toxic to some individuals.
While the FDA believes that the injuries are probably preventable if patients stop taking them and switch to another medication at the first sign of pain or swelling, there are many who have already suffered injuries. There may even be some who are unaware that their injury is drug-related.
If you or a loved one has been injured by pharmaceuticals, such as Cipro or Levaquin, please contact an experienced injury lawyer in your area. If you are taking Cipro or Levaquin, contact your physician immediately to discuss changing medication.
