Med Check

In July the Food and Drug Administration approved a new once-daily, higher-dose Aricept (donepezil) 23 mg tablet for the treatment of moderate to severe Alzheimer's disease. The approval is based on data from a large head-to-head study of the 23 mg tablet versus the 10 mg tablet in more than 1,400 patients with moderate to severe Alzheimer's. The approved label says the recommended starting dose of Aricept is 5 mg once daily and can be increased to 10 mg once daily after four to six weeks. Patients with moderate to severe Alzheimer's who successfully take the Aricept 10 mg tablet for at least three months are candidates for dose escalation to the 23 mg tablet. Aricept is co-promoted in the United States by Eisai Inc. and Pfizer Inc.

The FDA warned Novartis Pharmaceuticals Inc. in a letter in August about information it has posted on the social media Web site Facebook about Tasigna, a drug used to treat leukemia. The agency told the manufacturer that the Facebook content makes claims about efficacy without communicating risks associated with the drug. Regulation of the use of social media by the pharmaceutical and medical-device industries has been a topic of recent debate, and the FDA held hearings on the subject in November 2009 (Psychiatric News, December 18, 2009) and in February of this year.

The FDA warning letter is posted at <www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221325.pdf>.

The FDA sent out a reminder in August that physicians can continue to submit voluntary reports about serious adverse events associated with a drug, biologic, medical device, or dietary or cosmetic product to the agency's online MedWatch program. The FDA is particularly interested in learning about serious adverse events that are not listed in the product labeling. “Serious” is defined as fatalities, hospitalizations, and medically significant events.

Reports may be entered online at <www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm>.

In August the FDA announced that the results of an ongoing study sponsored by the FDA and the Agency for Health Quality and Research to study potential serious cardiovascular risks associated with medications used to treat ADHD in children and adults have been further delayed. The results of both studies are now expected in the first quarter of 2011. This delay, following at least two previous delays, is due to the logistical challenges of obtaining approximately 2,000 medical charts to confirm medical-claims diagnoses, as well as the technical challenges associated with pooling and analyzing data from approximately 1.5 million patient records across 12 health plans, according to the FDA.

Shire Pharmaceuticals announced in August that a phase 3b study published in Behavioral and Brain Functions showed that adults with ADHD who took once-daily Vyvanse (lisdexamfetamine dimesylate) demonstrated significant improvement.