FDA investigating several drugs for possible safety concerns

From Geriatric Pharmacy Intern, Allyson Torres, PharmD(c)
Nova Southeastern University College of Pharmacy

On Thursday, May 28, 2009 the FDA released its quarterly list of drugs that it is in the early stages of reviewing for potential safety concerns. The list contained about 2 dozen drugs, including the overactive bladder drug Detrol® (Pfizer) which is under review for reports of Steven-Johnson syndrome, a serious skin reaction, the smoking cessation drug Chantix® (Pfizer), which is under review for possible risk of accidental injury, vision impairment and other issues, sleep disorder drugs Nuvigil® and Provigil® (Cephalon) which are under review for serious skin reactions and the weight loss drugs Alli® (GlaxoSmithKline) and Xenical® (Roche Inc) for possible induction of liver toxicity.
Alli and Xenical (orlistat) are thought to actually be of value in TREATING certain liver problems, such as non-alcoholic fatty liver disease, in obese patients. Some research has shown that orlistat reduces fatty infiltration, improves inflammatory activity, improves hepatic fibrosis, lowers amino transferase levels, total cholesterol, triglyceride and LDL levels and reduces insulin resistance. However, other research shows no significant improvement, and recently there have been reports of liver toxicity in patients taking orlistat that are suspected to be related to its usage. As reported in the Journal of Hepatology by Montero et al in 2001, one patient developed sub-acute liver failure while being treated with orlistat as the only drug and had to receive a liver transplant. The FDA is clear that it has not yet determined causation in terms of the drugs under review and the reported adverse effects. It will be interesting to see if further research proves whether orlistat can either cause or help treat liver problems- or both!