The FDA issued a safety announcement on Thursday regarding commonly prescribed antibiotics such as Cipro and Levaquin. The announcement follows an FDA advisory panel in which 35 people testified about severe fluoroquinolone associated disability resulting from the use of Levaquin, Cipro, and Avelox. The drugs have been sold for more than 20 years and are generally prescribed to treat routine infections such as sinus and urinary tract infections.
The panel heard testimony about reactions including tendon rupture, aortic aneurism, mitochondrial damage, psychiatric events, peripheral neuropathy, damage to the central, peripheral and autonomic nervous systems, neurodegenerative disorders and more.
About 23 million patients per year have received prescriptions for these drugs between 2010 and 2014 most commonly for urinary tract infections
The FDA is now requiring label changes for fluoroquinolones, including an updated boxed warning and Medication Guide and advising that the serious adverse reactions associated with these medications outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections. The FDA had issued previous warnings about the drugs in 2008 and 2013, but did not advise doctors to restrict their use.
The FDA safety announcement can be found at:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
Showard Law Firm is Tucson’s local law firm for drug and medical device claims. If you or a loved one has been injured by a drug or medical device, call today for a free consultation at 520.622.3344.
