The FDA has identified the tainted over-the-counter products, but according to new research published Friday in JAMA Network Open, over half the time, the study found, the FDA doesn’t enforce recalls of supplements that knowingly include unapproved prescription drug ingredients.
Gizmodo notes that the FDA does regularly screen supplement products for unapproved pharmaceutical ingredients, usually added to enhance the product’s advertised effects. And any tainted products are included on a public database set up by the FDA’s Center for Drug Evaluation and Research.
Using the FDA database, Madhur Kumar, Ph.D., from the California Department of Public Health, Sacramento, and colleagues carefully analyzed data entered between 2007 and 2016.
Sexual enhancement – unapproved drugs
On the Tainted Supplements Database, each FDA warning included the date, product name, company, the name of the hidden ingredient identified, lot number, and an indication for which the product was marketed.
Discounting a number of multiple warning for some products, the researchers identified a total of 776 dietary supplements. The majority of the products included were marketed for sexual enhancement (45.5 percent), weight loss (40.9 percent), or muscle building (11.9 percent).
Additionally, 20 percent of the products contained more than one hidden drug ingredient. In the sexual enhancement products, 81.3 percent contained sildenafil and/or at least one of its structural analogs, and 20.4 percent contained tadalafil. Both of these drugs are phosphodiesterase-5 (PDE5) inhibitors used to treat erectile dysfunction are the main ingredients in Viagra and Cialis.
If that’s not bad enough, the researchers found that an unapproved drug, dapoxetine, a selective serotonin reuptake inhibitor (SSRI) antidepressant was found in 14 of the 353 sexual enhancement supplements on the list. One additional drug, the laxative phenolphthalein, was also identified.
Weight loss – unapproved drugs
As for the many weight-loss supplements on the market, Kumar and his colleagues found that sibutramine, a drug removed from the US market in 2010 because of cardiovascular risks was identified in 85 percent of the supplements. fluoxetine, a prescription antidepressant, was found in 5.4 percent of the products. Overall, 25 percent of weight loss products contained more than one unauthorized pharmaceutical.
Fluoxetine, also known by trade names Prozac and Sarafem, among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used for the treatment of a major depressive disorder, obsessive-compulsive disorder (OCD), bulimia nervosa, panic disorder, and premenstrual dysphoric disorder.
Almost all the muscle building supplements, 82 out of 92 products, contained synthetic steroids or steroid-like ingredients. There were 28 products named in 2 or 3 warnings more than 6 months apart. At least 19 of these products contained new unapproved ingredients in the second or third warning, consistent with the assumption that the FDA found the product to be adulterated more than once.
What did the FDA do about these supplements?
Actually, the FDA didn’t do much of anything, leaving some people to wonder why we have an agency that is supposed to protect the public’s health. Of the 776 adulterated supplements identified, the FDA requested a voluntary recall of fewer than half (46.4 percent). And of that amount, only 334 recalls were associated with a public notice.
“The FDA data show that anyone consuming sexual enhancement dietary supplements has the potential to be unknowingly consuming PDE5 inhibitors or SSRIs, risking interaction with other medications or pre-existing health conditions,” Kumar and colleagues write. Further, products containing stimulants such as sibutramine can pose “a risk to patients with a history of heart disease or stroke.”
“The agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk,” Dr. Pieter Cohen, a general internist at Cambridge Health Alliance in Somerville, Massachusetts, wrote in a commentary accompanying the study.
It is highly recommended by the authors that anyone wanting to take a supplement talk with their physician first. Most of these supplements are made in other countries and there is no assurance that quality control or safety is even taken into consideration in the manufacturing process.
Why the FDA has not done more to get these products removed from the market is being questioned. “Often, there’s this excuse about a lack of resources. But if there was a true lack, then you wouldn’t be able to do the chemistry to detect these hidden drugs in the first place,” Cohen said. “So it seems more like a lack of motivation than resources. Because there is a clear set of steps you can take.”
