For this study, the authors aimed to quantify this effect by conducting a systematic review of various databases to identify studies that included a placebo arm and used Female Sexual Function Index as a clinical outcome.
The labeling changes are based on a review of postmarketing adverse event reports found in the FDA Adverse Event Reporting System (FAERS) database and published medical literature.
The treatment combines buprenorphine, a partial-opioid agonist, with naloxone, an opioid antagonist.
The guidelines were developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
These Medication Guides should be provided the first time an outpatient receives a GBCA injection at an MRI center; hospital patients are not required to receive a Medication Guide.
The FDA is urging manufacturers to stop marketing OTC oral drug products containing benzocaine for teething to this patient population.
The FDA has issued a new safety communication requiring that changes be made to the labeling of prescription cough and cold medicines containing codeine and hydrocodone.
The FDA has seen an increase in the number of reported adverse events related to biotin interference for certain lab tests.
