Re: drugs doctors would never take

[Guest guest]

FDA Mandates Black Box Warning for Some Antibiotics

I just found out about the problems with fluoroquinolones. My husband

has tendonitis in his adductor longus and the pain is terrible. He

took CIPRO two years ago for quite a while after surgery. The new FDA

ruling was in the paper the other day, and then I researched it on the

net.

By Reinberg

HealthDay Reporter

TUESDAY, July 8 (HealthDay News) — Antibiotics known as

fluoroquinolones will need to carry a black box warning alerting

physicians to the increased risk of tendonitis and tendon rupture

associated with their use, the U.S. Food and Drug Administration said

Tuesday.

The FDA is also asking doctors to advise their patients that if they

have any sign of tendon pain and swelling or inflammation, they should

stop taking the drugs immediately. Patients also should avoid

exercising the affected area and contact their doctor immediately.

Tendon rupture can occur during or after taking fluoroquinolones,

which include Cipro. Cases of tendon rupture have been reported up to

several months after completing fluoroquinolone therapy, according to

the FDA.

The drugs affected by the warning include:ciprofloxacin (marketed as

Cipro and generic ciprofloxacin); ciprofloxacin extended release

(marketed as Cipro XR and Proquin XR); gemifloxacin (marketed as

Factive); levofloxacin (marketed as Levaquin); moxifloxacin (marketed

as Avelox); norfloxacin (marketed as Noroxin); and ofloxacin (marketed

as Floxin and generic ofloxacin).

The FDA is also notifying makers of fluoroquinolones that they need to

develop and distribute a medication guide for patients, alerting them

to the possible side effects.

" All the currently marketed fluoroquinolones contain warnings

regarding the risk of tendon-related adverse events, including the

risk of tendon rupture, " Dr. , director of the Office of

Antimicrobial Products at the FDA's Center for Drug Evaluation and

Research, said during an afternoon teleconference. " The new language

will strengthen the existing warnings. "

" Despite the current warning information on tendon adverse events and

tendon rupture, the FDA continues to receive a considerable number of

reports of tendon-related adverse events, " said. " The FDA believes

the new labeling changes will better inform health-care providers and

patients about the risk of tendon rupture. "

Makers of fluoroquinolones are required to submit the changes to the

label to the FDA within 30 days, said.

Dr. Renata Albrecht, director of the Division of Special Pathogen and

Transplant Products at FDA's Center for Drug Evaluation and Research,

said the ruptures " occur most frequently in the Achilles' tendon. "

Achilles' ruptures associated with fluoroquinolones are three to four

times more frequent than ruptures among people not taking these drugs,

Albrecht said. In the general population, the rate of tendon ruptures

is about one in 100,000, she noted.

Signs and symptoms of tendon rupture can include a snap or pop in a

tendon area, bruising after an injury in a tendon area, inability to

move the affected area or bear weight, the agency said.

The FDA said pain, swelling, inflammation, and tears of tendons —

including the Achilles, shoulder, hand, or other tendons — can happen

in patients taking fluoroquinolone antibiotics. Tendons are the areas

that connect muscles to joints.

Prior to requesting the black box warning, the FDA had been sued by

the consumer group Public Citizen for ignoring " long-standing

evidence " that fluoroquinolones can cause tendon ruptures. The

consumer group had been calling upon the agency to add such a warning

since 2006.

In January, Public Citizen said that from November 1997 through

December 2005, the FDA had received 262 reports of tendon ruptures

among fluoroquinolone users. Most involved ruptures of the Achilles'

tendon. The group also cited hundreds of additional cases of

tendonitis and other tendon disorders.

Fluoroquinolones are drugs approved for the treatment or prevention of

certain bacterial infections. Like other antibacterial drugs,

fluoroquinolones don't treat viral infections such as colds or the flu.

After Tuesday's announcement, Dr. Sidney Wolfe, director of the Health

Research Group at Public Citizen, said the black box warning

accomplishes two of the three steps that Public Citizen has urged the

FDA to take for nearly two years.

But, he added in a news release, " The FDA is silent on our request

that it also send a warning letter to physicians clearly describing

possible adverse reactions, such as tendon pain, so that patients can

be switched to alternative treatments before tendons rupture. "

SOURCES: July 8, 2008, teleconference with , M.D., director,

Office of Antimicrobial Products, Center for Drug Evaluation and

Research, U.S. Food and Drug Administration; Renata Albrecht, M.D.,

director, Division of Special Pathogen and Transplant Products, Center

for Drug Evaluation and Research, U.S. Food and Drug Administration;

July 8, 2008, news release, Public Citizen, Washington, D.C.