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April 03, 2019 at 12:00 AM
The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users.
February 25, 2019 at 12:00 AM
FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis
December 20, 2018 at 12:00 AM
FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
November 20, 2018 at 12:00 AM
FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
November 14, 2018 at 12:00 AM
The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.