 | | | | Related Healthscout Videos | |
|
Page: << Prev | 1 | 2 | 3 | Next >> "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," Cox 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, Cox 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."
Text Continues Below
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.
Page: << Prev | 1 | 2 | 3 | Next >>
|
.gif)
