The FDA has approved labeling changes for erectile dysfunction drugs in the class that includes tadalafil (Cialis), vardenafil (Levitra), and sildenafil citrate (Viagra), to display more prominently the potential risk of sudden hearing loss and to guide consumers on what to do if they experience sudden problems with their hearing.
The FDA has approved labeling changes for erectile dysfunction drugs in the class that includes tadalafil (Cialis), vardenafil (Levitra), and sildenafil citrate (Viagra), to display more prominently the potential risk of sudden hearing loss and to guide consumers on what to do if they experience sudden problems with their hearing.
The FDA asked manufacturers of phosphodiesterase type-5 inhibitors to revise product labeling after a small number of patients taking the drugs reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.
“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, MD, of the FDA’s Center for Drug Evaluation and Research.
Patients who are taking any of the three drugs and experience sudden hearing loss are being instructed to immediately stop taking the drug and seek prompt medical attention. Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class, the FDA said.
EV/pembrolizumab under review in China for advanced urothelial carcinoma
March 28th 2024The sBLA is supported by findings from the phase 3 EV-302 trial, which showed that EV/pembrolizumab extended overall survival and progression-free survival vs platinum-based chemotherapy in patients with advanced urothelial carcinoma.
Potential code for prior authorizations on AMA CPT Editorial Panel meeting agenda
March 28th 2024"Good public and economic policy must align costs, benefits, and incentives; currently, all costs are incurred by physician practices, and all financial savings and benefits from prior authorization accrue to health insurance plans, leading to perverse incentives,” says Alex Shteynshlyuger, MD.