CMAJ • April 28, 2009; 180 (9). doi:10.1503/cmaj.090580.
© 2009 Canadian Medical Association or its licensors
All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association.
Wayne Kondro
© 2009 Canadian Medical Association or its licensors
All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association.
|
For the record
CMAJ
Tainted weight-loss products
The United States Food and Drug Administration (FDA) has expanded its list of tainted, over-the-counter weight-loss products that consumers should not purchase or consume because they contain undeclared and unapproved "active pharmaceutical ingredients."
The FDA list of illegal products now tallies 72 (www.fda.gov/cder/consumerinfo/weight_loss_products.htm).
Among weight-loss products added to the FDA’s outlaw list were Herbal Xenicol, Slimbionic and Xsvelten. Among new undeclared drug ingredients that were discovered in weight-loss products and added to the list in late March were:
- fenproporex, an amphetamine derivative whose side effects can include tachycardia, blurred vision, uncontrollable movements and even sudden death;
- fluoxetine, a member of the selective serotonin reuptake inhibitor class, which must be labelled as increasing the risk of suicide and suicidal thinking in children;
- furosemide, a prescription diuretic used for the treatment of congestive heart failure, high blood pressure and edema, which is known to have such side effects as severe dehydration;
- cetelistat, an experimental obesity drug now in clinical trials, which has demonstrated such adverse reactions as "fecal incontinence, rectal discharge, and defecation urgency."
"These tainted weight-loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages," stated Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release announcing the additions.
"Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health."
The FDA indicated it has sought recalls of the illegal products and "may" pursue additional measures, including criminal charges.
Health Canada has issued warnings for 6 weight-loss products (www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/weight-amaigr-eng.php).
Although many have called for legislation subjecting weight-loss products to regulatory approval, including CMAJ, there have been no signs that the government will move in that direction (CMAJ 2009;180[4]:367).
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||