In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
Drug Safety: Fasinumab Evaluated in Clinical Trials, Plus Celecoxib May Not Pose Increased Heart Attack or Stroke Risk
After an independent review, ongoing clinical trials investigating the safety of fasinumab for treating hip or knee OA will discontinue the use of higher fasinumab doses…
FDA Staff Raises Safety Concerns Over Arthritis Drug Baricitinib
(Reuters)—An experimental rheumatoid arthritis drug developed by Eli Lilly and Co. and Incyte Corp. poses serious risks of deadly blood clots at higher doses, U.S. Food and Drug Administration staff says, the latest setback to a treatment regulators declined to approve last year. New data provided by the companies in a resubmission of their marketing…
FDA Receives Reports of Loperamide Abuse
The FDA is seeking to limit the number of loperamide doses per package due to reports of heart-related problems and death from the misuse and abuse of the treatment…
FDA Removes Boxed Warning for Combination Asthma Treatment
Post-market clinical safety trials have indicated that medications containing both long-acting beta agonists (LABAs) and inhaled corticosteroids (ICSs) do not result in more serious asthma-related outcomes than treatment with ICSs alone…
Flimsy Evidence Behind Many FDA Approvals
(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in JAMA, online Aug. 15. The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the…
Sirukumab Approval Stalls
Citing safety concerns, the FDA Arthritis Advisory Committee voted against recommending approval of sirukumab for treating adults with RA…
More Than a Third of U.S. Adults Prescribed Opioids in 2015
(Reuters Health)—The U.S. needs to curb excessive opioid prescribing and improve access to pain management techniques, suggests a new government study. Researchers found that more than one third of U.S. adults were prescribed the medications in 2015 and many also misused the drugs. “A very large proportion and large number of adults use these medications…
Opana ER Pulled from U.S. Market
Endo Pharmaceuticals will work with the FDA to coordinate the organized removal of Opana ER from the U.S. market.
FDA Update: New Boxed Warnings for Opioids & Benzodiazepines; Plus New Drug Safety Labeling Changes Database
Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication…