 New FDA Warning About Antibiotics
After two years of refusing to issue its most urgent safety warning about Levaquin, Cipro and other fluroquinolone drugs, the Federal Drug Administration has finally ordered manufacturers of the antibiotics to apply the warning to prescriptions for the drugs.
The manufacturers must also include an FDA-approved medication guide with prescriptions of the drugs. The popular antibiotics are often prescribed for bacterial infections. But they can cause tendinitis and tendon rupture in patients over the age of 60 and those taking corticosteroid drugs and in kidney, heart and lung transplant recipients.
Achilles tendon rupture is the most common. But tendons in the shoulder, hand, thumb and other parts of the body also can be affected by the drugs. The FDA says the ruptures can leave patients incapacitated and in need of extensive surgery. Some patients taking the antibiotics also have reported convulsions, hallucinations, depression, abnormalities in the heart rhythm and severe diarrhea.
Doctors say that tendon ruptures can be averted if patients stop taking the drugs at the first sign of tenderness and swelling or pain in a tendon. They should quit exercising and report the symptoms immediately to their doctors. Until now, labels on prescriptions of the drug carried a warning about the possibility of tendon rupture but it was not emphasized. The FDA says it changed its policy due to the number of reports it continued to receive about tendon rupture. It said the reports indicated that the message “may not have gotten through to doctors and their patients” and warranted more emphasis to get their attention about this side effect of Cipro, Levaquin and other quinolone antibiotics.
The new FDA warning comes after mounting criticism and ultimately, law suits, against the federal agency for refusing to order the highest safety alert for these drugs. Public Citizen, a national non-profit organization that advocates for public health and the State of Illinois, sued the FDA two years ago after unsuccessful appeals to the federal agency to elevate warnings on the drug to the highest level. In a recent statement, Public Citizen Public Citizen cited 407 cases of tendon rupture between November 1997 and December 2007 and 341 cases of tendinitis. But it warned that cases of tendon rupture may far exceed the number reported to the FDA since “only a small fraction of cases are typically reported” to the federal agency. |
