Drug safety officials on July 8, 2008, imposed the government’s most urgent warning on Cipro and similar antibiotics. Officials cited evidence that they may lead to tendon ruptures, a serious injury which can leave patients incapacitated and needing extensive surgery.
The FDA ordered makers of flouroquinolone drugs — a potent class of antibacterials — to add a very visible “black box” warning to their products and write new literature warning patients.
The two leading drugs covered by the warning are Bayer’s Cipro and Ortho-McNeil’s Levaquin. Cipro became a household name during the hysteria after the anthrax attacks of 2001. Cipro is thought to be effective against that bacteria, and it’s among the medications stockpiled by the government. In everyday medicine, Cipro is often used to treat urinary tract infections. Levaquin is generally used to treat respiratory infections.
The FDA’s action came after consumer group Public Citizen petitioned and then sued the agency to create such warnings. Regulators took too long to act, said Sidney Wolfe, head of the consumer group’s health section. Many injuries, Wolf said, “would have been prevented if patients and doctors had known a pain in the tendon is an early sign that leads to rupture.” Public Citizen filed its original petition nearly two years ago.
FDA officials said that prescribing literature for the drug class already carried clear warnings of the risk of tendon rupture. They said the agency acted to emphasize the warnings because continued reports of injuries indicated that the message may not have gotten through to doctors and patients.
FDA officials pointed out that prescribing literature for the drug class already carried clear warnings of the risk of tendon rupture. They said the agency acted to emphasize the warnings because continued reports of injuries indicated that the message may not have gotten through to doctors and patients.
“The continued reports demonstrate additional steps are warranted to better manage the risk of tendon rupture,” said Renata Albrecht, director of an FDA office that focuses on unusual microbes.
FDA officials said they had received several hundred reports of tendon ruptures, but refused to cite a specific number. Wolfe said the number was 407 at the end of 2007, with another 341 reports of tendinitis. He said the FDA should also require drug makers to send individual letters to doctors about the risks. FDA officials said manufacturers could choose to send such letters on their own.
Tendons are cords of tissue that join muscles and bones, and are essential in movement. The most common kind of rupture reported to the FDA involved the Achilles tendon in the heel, but some also involved the rotator cuff in the shoulder, and tendons in the hands, biceps, and even the thumb.
Some of the ruptures reported to the FDA occurred without warning – the patient felt a snap or pop soon after starting treatment. The FDA said that suggests flouroquinolone antibiotics may be toxic to some.
Patients who suffered a tendon rupture typically felt some kind of pain or inflammation for a week or two before, which suggests that many of the most serious problems can be avoided if patients stop the drug, officials said.
The FDA’s analysis found that patients with the highest risk of problems include people over 60, those with kidney, heart and lung transplants, and those also taking steroids.