CIPRO and other realted....FDA calls for urgent warning on tendon risks

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FDA calls for urgent warning on tendon risks

By RICARDO ALONSO-ZALDIVAR – 1 hour ago

WASHINGTON (AP) — Drug safety officials Tuesday imposed the

government's most urgent safety warning on Cipro and similar

antibiotics, citing evidence that they may lead to tendon ruptures, a

serious injury that can leave patients incapacitated and needing

extensive surgery.

The Food and Drug Administration ordered makers of flouroquinolone

drugs — a potent class of antibacterials — to add a prominent " black

box " warning to their products and develop new literature for

patients emphasizing the risks.

Tendon ruptures are normally thought of as sports injuries, generally

occurring usually among men in their mid-thirties. The link to

treatment with the antibiotics is highly unusual, and scientists

still don't fully understand why it happens. However, FDA officials

stressed that many of the serious injuries appear to be preventable

if patients stop taking the drug at the first sign of pain or

swelling in a tendon, call their doctor, and switch to another

antibiotic.

The two leading drugs covered by the warning are Cipro, made by

Bayer, and Levaquin, which is made by Ortho-McNeil. Cipro became a

household name during the anthrax attacks of 2001. It is effective

against that deadly bacteria, and is among the medications stockpiled

by the government in case of a bio-terror attack. 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 the consumer group Public Citizen

petitioned_and later sued_the agency for such warnings. Regulators

took too long to act, complained Sidney Wolfe, head of the consumer

group's health section. Many injuries " would have been prevented if

patients and doctors had known a pain in the tendon is an early sign

that leads to rupture, " Wolfe said. Public Citizen's original

petition was filed nearly two years ago.

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 would not cite a specific number. Wolfe, of

Public Citizen, said the number was 407 at the end of 2007, with

another 341 reports of tendinitis. He continued to criticize the

agency, saying it 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. That

suggests flouroquinolone antibiotics may be toxic to some people, the

FDA said.

But typically, patients felt some kind of pain or inflammation for a

week or two before they suffered a tendon rupture. That 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.

On the Net: (http://www.fda.gov/cder/index.html)