The FDA's expert advisory committee recommended that warning labels be added to the popular flu drugs, Tamiflu and Relenza, after releasing its safety review of the two medications in late November. The review includes reports of bizarre behavior (such as running into traffic and falling from windows or balconies), as well as hallucinations and delirium. Initial responses from the drug companies suggest they are willing to consider a label change. The FDA is not required to take the recommendations of its expert advisors.
Source: Perrone, Matthew, FDA Wants Warning on Flu Drugs for Kids, Yahoo! Finance, posted November 23, 2007.
The schizophrenia medication, Abilify, originally approved in 2002, received the green light for the treatment of adolescents with schizophrenia on November 6, according to Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Ltd. of Japan.
Source: Reuters Health Information
DailyMed provides high quality information about marketed drugs, including FDA approved labels (package inserts). This web site offers health information providers and the public a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts: http://dailymed.nlm.nih.gov/dailymed/about.cfm
Other information about prescription drugs is also available through the National Library of Medicine (NLM). The NLM regularly processes data files uploaded from the FDA's system and provides and maintains this web site for the public to use in accessing the information. Additional information about medicines is available on NLM's MedlinePlus web site: http://www.nlm.nih.gov/medlineplus/medicines.html
| join our newsletter mailing list |