Side effects are often worse than the cure
Certain antibiotic drugs such as Bayer AG’s Cipro need stronger “black box” warnings about the risk of tendinitis and ruptured tendons, US health regulators said.
The warnings also would apply to Bayer’s Avelox, Oscient Pharmaceuticals Corp’s Factive and Depomed Inc’s Proquin XR.
They would also affect Johnson & Johnson’s Levaquin and Floxin and Merck & Co Inc’s Noroxin. The drugs are members of a family known as fluoroquinolones.
Cipro is sold by various generic makers as ciprofloxacin and Floxin is sold generically as ofloxacin.
Labels for the antibiotics already include cautions about the tendon problems. Despite those warnings, “the FDA continues to receive a considerable number of reports of tendon-related adverse events,” Edward Cox, director of the agency’s antimicrobial products office said. “The FDA believes that these new labeling changes will better inform health-care providers and patients about the risk,” Cox said.
The risk is greater in patients ages 60 and older, those who have had certain organ transplants and those using steroid therapy, the agency said. It added that doctors should restrict use of the drugs to conditions clearly caused by bacteria. Patients with tendon pain should immediately stop taking the drug, halt any exercise and call a doctor, the FDA said.
The estimated risk of tendon ruptures is about three to four times higher with fluoroquinolones, said Renata Albrecht, head of the FDA’s division of special pathogen and transplant products. The rate in the general population is about 1 in 100,000, Albrecht said. Most cases involve the Achilles tendon, which attaches the calf muscle to the heel. Less frequent ruptures affected tendons in the shoulders, biceps, hands and elsewhere.
Via The Times