Safety Requirements For Clozapine. The U.S. Food and Drug Administration (FDA) is changing certain safety requirements for ‘Clozapine’, a medication used to treat patients with schizophrenia. According to a Drug Safety Communication issued on Sept. 15, the agency is modifying requirements for monitoring, prescribing, dispensing and … [Read more...]
FDA Updates Requirements for Clozapine in Light of Neutropenia Risk
FDA Updates Requirements for Clozapine in Light of Neutropenia Risk
Clozapine May Cause Severe Neutropenia. The U.S. Food and Drug Administration (FDA) is changing certain safety requirements for clozapine, a medication used to treat patients with schizophrenia. According to a Drug Safety Communication issued on Sept. 15, the agency is modifying requirements for monitoring, prescribing, … [Read more...]
Biogen Idec Restarts Tysabri Updates
Biogen Restarts Tysabri Update. The maker of Tysabri will once again provide monthly updates regarding new cases of progressive multifocal leukoencephalopathy, or PML, an often fatal brain infection seen in some people treated with the multiple sclerosis (MS) drug. Biogen Idec Inc. had stopped providing the monthly PML updates last … [Read more...]
Updated Definity Optison Warning
FDA Updates About Definity And Optison Warning. Healthcare providers were notified today about labeling changes for Definity and Optison, micro-bubble contrast agents used in sonograms of the heart. The revised Boxed Warning and Warnings continue to highlight the risk of serious cardiopulmonary reactions during or within 30 minutes … [Read more...]
FDA Updates Plan for Office in China
FDA Updates In China. In March we reported that the US Food and Drug Administration (FDA) received approval from the US State Department to establish eight full-time, permanent positions at US diplomatic posts in the People's Republic of China, pending authorization from the Chinese government. This was one step in the FDA's plans … [Read more...]
FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing
FDA Updates Labeling For Viagra, Cialis and Levitra Associated With Eye Problems. The Food and Drug Administration (FDA) has approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition … [Read more...]
