Physicians have been advised to avoid prescribing these agents for uncomplicated infections unless there were no other options. Now, that advice will be carried on the drugs' package inserts. From MedPage Today.
This article first appeared July 29, 2016 on the MedPage Today website.
By John Gever
An earlier warning from the FDA about serious musculoskeletal complications from fluoroquinolone antibiotics will now be included in the drugs' labels, the agency said Tuesday.
"These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient," the FDA explained in a Drug Safety Communication.
In the agency's previous announcement, it advised physicians to avoid prescribing these agents for uncomplicated infections unless there were no other options. Now, that advice will be carried on the drugs' package inserts.
The labels will also state that these agents should be reserved for patients "who have no other treatment options" for treating acute bacterial sinusitis, bronchitis, or urinary tract infections, "because the risk ... generally outweighs the benefits in these patients.
Fluoroquinolones -- a category that includes such familiar brand names as Cipro, Levaquin, Avelox, and Factive, with the identifying generic suffix "-floxacin" -- previously carried a boxed warning about tendinitis and tendon rupture and worsening of myasthenia gravis. The revised warning will now note that these effects may be permanent and disabling and may involve multiple body systems. Labels will also list an expanded range of serious potential side effects, ranging from skin rashes to hallucinations.
The warning were based mainly on a review of 178 reports of persistent (mean duration 14 months) adverse effects in previously healthy patients who used fluoroquinolones for common, uncomplicated infections. Long-lasting pain was the most common effect described.