Antibiotics can harm tendons, FDA warns
Tue Jul 8, 2008 11:18pm BST

By Susan Heavey

WASHINGTON (Reuters) - Certain antibiotic drugs such as Bayer AG's Cipro
need stronger "black box" warnings about the risk of tendonitis and
ruptured tendons, U.S. health regulators said on Tuesday.

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, told reporters.

"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 Dr. 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.

Patients may recover if they act before a rupture, while others need
surgery to repair a torn tendon. Even with surgery some patients may not
return to normal, Albrecht said.

The FDA was sued earlier this year by consumer group Public Citizen,
which had petitioned for the boxed warnings in 2006.

At the time, the group said government data showed 262 reported tendon
ruptures, 258 cases of tendonitis and 274 other tendon disorders through
the end of 2005. Since then, roughly 100 more cases have been reported,
Sidney Wolfe, head of Public Citizen's Health Research Group, told
Reuters on Tuesday.

The FDA's Albrecht said several hundred cases of tendon- related
problems had been reported.

Public Citizen, which was calling for tendon warnings as far back as
1996, also sued the FDA to require companies to notify doctors directly
about the risk, something the FDA did not order on Tuesday.

"If the doctor is left out of the loop, it just doesn't make any sense,"
Wolfe said.

Companies will be required to provide guides for patients about possible
side effects, the FDA said.