Harsher warning on Cipro sought

ASSOCIATED PRESS

The labels on Cipro and similar antibiotics should bear more serious warnings about a link to tendon injuries, petitioners told federal health officials yesterday.

From 1997 to 2005, the Food and Drug Administration received 262 reports of ruptured tendons in patients using drugs from the fluoroquinolone class of antibiotics, the consumer advocacy group Public Citizen said in its petition to the FDA.

The FDA will review the petition, agency spokeswoman Susan Cruzan said. She declined to say what action — if any — the agency would take in response to a similar petition filed last year by Illinois, which asked yesterday that the two requests be combined.

Staci Gouveia, a spokeswoman for Bayer HealthCare, maker of Cipro, declined to comment.

The labels on the entire class of drugs warn doctors and patients of tendon problems. The FDA had manufacturers add that language after a 1996 Public Citizen petition. Public Citizen and the Illinois attorney general’s office now worry that the problem is worsening as use of the drugs increases.

Beyond the tendon ruptures, Public Citizen also cataloged about 260 cases each of tendinitis and other tendon disorders among users of the drugs. It is not clear how the drugs might cause the injuries.

The two petitioners want the drugs to bear so-called “black box” warnings. That is the most severe warning the FDA can require.

They also want manufacturers of the drugs to issue “Dear Doctor” letters about the risk and the requested label changes.

The office of Illinois Attorney General Lisa Madigan said it became interested in the subject after receiving complaints from consumers who suffered tendon problems after taking another of the antibiotics, Levaquin.

Levaquin’s label “clearly states” tendon rupture can occur during or after treatment with the antibiotic, said Ambre Morley, a spokeswoman for Ortho-McNeil Inc., the Johnson & Johnson subsidiary that makes the drug.