News Article: FDA Warns of Risky Weight Loss Pills

            On December 22, 2008 the FDA issued a press release warning consumers about the dangers of using 28 weight loss products. The FDA reports that many over-the-counter weight loss products such as “Fatloss Slimming,” “ProSlim Plus,” and “Super Fat Burner,” are being marketed without disclosing all active ingredients. After FDA analysis, many of these products were found to contain ingredients that are controlled substances, prescription products, or unapproved in the United States.

            These products have been found to contain drugs such as sibutramine, rimonabant, phenytoin, phenolphthalein, and bumetanide. Sibutramine, marketed under the trade name Meridia® in the U.S., is a schedule IV controlled substance. It is a centrally acting appetite suppressant. These products contain undisclosed amounts of this drug, and consumers can experience rapid heartbeat, high blood pressure, seizures, heart attack, and stroke. Sibutramine can also interact with other medications such as MAOIs, SSRIs, and St. Johns Wort. Use of sibutramine with any of these drugs may lead to a potentially fatal syndrome called serotonin syndrome which is characterized in part by increased heart rate, sweating, and dilated pupils.

            Rimonabant is not currently marketed in the U.S. due to concerns over patient safety. Rimonabant is under investigation in the U.S. for the treatment of obesity and smoking cessation. Possible side effects of rimonabant include depression, anxiety, and suicidal ideation. This drug has been linked to 5 deaths in Europe over the last two years.  Phenytoin and bumetanide are both drugs that are available in the U.S. Phenytoin has many adverse effects involving the CNS and GI tract, and can also result in a serious dermatological reaction called Stevens-Johnson syndrome. Phenytoin can also interact with many medications. Bumetanide is a diuretic medication which can cause hypotension, electrolyte unbalances, and renal failure. Phenolphthalein is an oral irritant/ stimulant laxative that was banned from the U.S. market in 1999 due to cancer risk.

            A full list of the weight loss products that contain these ingredients can be found on the FDA webpage. The FDA advises consumers not to use any of these drug products, and to seek medical attention if they have already used one of these products. The FDA has also taken measures to remove these unauthorized drug products from the market, including issuing drug recalls, performing manufacturer inspections, and may move forward with criminal charges.  Since the report was issued, another 41 products have been identified that are being marketed with undeclared active ingredients.

References:

1. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html
2. FDA MedWatch Online: www.fda.gov/MedWatch/report.htm
3. Clinical Pharmacology
4. Micromedex Poisondex

Monica Pipes, Doctor of Pharmacy Candidate