Fingolimod is classified as a pregnancy category C drug, and thus its safety in human pregnancy is not clearly established. ... Key Point. Fingolimod is classified as a pregnancy category C drug (safety in human pregnancy not clearly established) and
with the drug are likely to outweigh its potential risks for each patient. ... Approved on the fast track as an orphan drug, safety and efficacy were evaluated in 4 clinical trials including 547 treated patients.
Yea-Jen Hsu, PhD, MHA, senior research associate. Jodi Segal, MD, MHP, co-director, Johns Hopkins Center for Drug Safety and Effectiveness; associate director, Center for Health Services and Outcomes Research.
A labeling update and drug safety communication on low-molecular-weight heparin, including enoxaparin, regarding the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and ... Safety and
The agency had previously warned that this dose of the anti-nausea drug should be avoided due to the risk of QT-interval prolongation, which can lead to torsades de pointes.
Rutgers University in Newark, N.J., and president of BLCMD Associates LLC in Chapel Hill, N.C., which offers consulting services in drug safety. ... Indeed, in the November 2011 Drug Safety, researchers published a study examining the prescription data
However, the FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks, according to the agency's drug safety update.
dose should exceed 16 mg, according to the agency's drug safety communication online. ... The FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue but has not changed its recommendations regarding the drug.
a study drug, one of them a first-ever prescription, between January 1998 and December 2001. ... Overall, 76.3% of patients in the study-drug group received a prescription for a benzodiazepine, 38.8% received a prescription for a “Z” drug, and 13.4%
A warning about drug interactions between boceprevir (Victrelis) and ritonavir-boosted HIV protease inhibitor drugs. ... However, the FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks, according to