The focus this week is on safety, safety, safety. In addition to the drug actions taken below, there were safety warnings on baby food due to a possible botulism connection and one on peanut butter due to salmonella.
- FDA Proposes to Strengthen Label Warning for Xolair – The agency announced this week that it has requested Genentech, Inc. add a boxed warning to the product label for omalizumab, marketed as Xolair. The boxed warning emphasizes that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis.
- FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events – The agency directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.
- FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet – An interesting development that impacts proposals for importation, a warning was issued regarding drugs purchased over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead appeared to be haloperidol, a powerful anti-psychotic drug. According to the agency several Internet consumers sought emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product.
Have a good week everyone.