US Pharm. 2007;32(6):62.

Antidepressant Warnings Widen
Continuing an initiative that began in 2005, the FDA proposed that antidepressant medication manufacturers update the existing black box warning to include increased risks of suicidality in young adults ages 18 to 24 during initial treatment, generally the first one to two months. The proposed label changes also include language stating that scientific data failed to show this increased risk in adults over the age of 24, and that adults ages 65 and older taking antidepressants have a decreased suicidality risk.

The proposed changes apply to the entire category of antidepressants. Individual, placebo-controlled scientific studies are reasonably consistent, the agency says, in showing a slight suicidality increase in patients taking antidepressants in early treatment. The data are not sufficient to exclude any single medication from the increased risk.

Cautions on Glycerin Contamination
Concerned about reports of human deaths in other countries, the FDA is advising drug manufacturers, suppliers, re-packers, and health professionals who compound medications to be vigilant to ensure that glycerin is free of diethylene glycol (DEG), a known poison used in antifreeze and as a solvent. Glycerin is a sweetener commonly used worldwide in liquid OTC and prescription drug products.

The agency does not believe that the domestic supply of glycerin is contaminated with DEG, but it is making the current recommendations as a result of recent incidents around the world. In Panama last fall, more than 40 deaths occurred following DEG contamination of glycerin in cough syrup. In 1995/1996, some 80 children died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup, and between 1990 and 1998, similar DEG-poisoning incidents were reported in Argentina, Bangladesh, India, and Nigeria, resulting in hundreds of deaths. 

Health Risk Alerts on Two ED Drugs
The FDA is advising consumers against using two products promoted as dietary supplements for the treatment of erectile dysfunction and as sexual enhancements. The agency says "True Man" and "Energy Max" are illegal drug products that contain analogs, substances with similar structures to the active ingredients vardenafil and sildenafil found in the approved prescription drugs Levitra and Viagra, respectively.

The undeclared analog substances found in the supplements may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may drop blood pressure to dangerous levels. Men with high blood pressure, high cholesterol, or heart disease frequently take nitrates.

Electronic Products Debut
FDA launched two new electronic resources for consumers: a Web page called "Consumer Health Information for You and Your Family" and an electronic newsletter called "FDA Consumer Health Information." The new Web page ( consumer) offers important public health developments in easy-to-read language, with links to other government health information and online Spanish-language publications. The monthly E-newsletter, which replaces the agency's print publication, FDA Consumer, features the latest health news, safety warnings, and product approvals. Subscribers can sign up free of charge by visiting

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