Serious complications can occur when there are undeclared substances in drugs and supplements. Two recent U.S. Food and Drug Administration (FDA) recalls highlight the dangers of when supplements contain undeclared drugs.
Sildenafil in Sangter Energy Supplements
In August 2022, Distributor RFR, LLC issued a nationwide voluntary recall of Sangter Energy Supplements (3000mg) due to the presence of undeclared sildenafil. The supplements are marketed as dietary supplements for male sexual enhancement. The presence of sildenafil in the supplements makes them unapproved because the safety and efficacy of the supplements have not been properly tested.
The use of Sangter Energy Supplements with the undeclared sildenafil poses a risk to consumers because it could interact with nitrates in certain prescription drugs such as nitroglycerin. The interaction between the drugs could cause a significant drop in blood pressure which can be life-threatening. The FDA explained that among the adult male population who are most likely to use these products, adult males who use prescription drugs with nitrates for cardiac conditions are the most at-risk for complications.
There have not been any reports of adverse events yet, but the supplements were distributed in Florida retail stores in addition to nationwide through the Sangter website.
Sildenafil is used to treat male erectile dysfunction (ED) and is the active ingredient in Viagra. It works by increasing blood flow to the penis to help men get and keep an erection. It is a phosphodiesterase (PDE-5) inhibitor and prevents an enzyme called phosphodiesterase type-5 from working too quickly.
Tadalafil in Launch Sequence Capsules
On June 27, 2022, Loud Muscle Science, LLC issued a voluntary recall of Launch Sequence capsules due to the presence of undeclared tadalafil in the United States and Canada. The Launch Sequence capsules included Launch Sequence Aphrodisia and Euphoria Capsules. The capsules were marketed as dietary supplements for male sexual enhancement. The capsules were sold nationwide in the United States and Canada through Amazon, eBay.com, and retail stores.
Laboratory analysis found that the products included tadalafil. Tadalafil is an FDA-approved product to treat male erectile dysfunction (ED). It’s from a family of drugs known as phosphodiesterase (PDE-5) inhibitors and is commonly known by its commercial name, Cialis. The drug is used to treat ED by increasing blood flow to the penis during sexual stimulation in order to cause an erection.
Although tadalafil is an FDA-approved drug, it has not been approved in Launch Sequence capsules. Therefore, the Launch Sequence capsules that include tadalafil are unapproved drugs because their safety and efficacy have not been tested. Consuming an undeclared drug is dangerous because unwanted and potentially serious side effects can occur when the undeclared drug interacts with other medicines in the body.
Potential adverse health complications of consuming undeclared tadalafil are severe and potentially life-threatening hypotension related to drug interactions with medications such as nitroglycerin or guanylate cyclase inhibitors. If used in the expected use population of the Launch Sequence capsules, serious hypotension can cause a heart attack, stroke, or even death.
As of now, Loud Muscle Science has not received any reports of adverse events related to the recall. For a list of the recalled Launch Sequence capsules, see this list.
How Goldenberg Lauricella Can Help You
If you or a loved one were harmed by the presence of an undeclared drug in a product, contact the Drug Safety Attorneys at Goldenberg Lauricella. Our team has the compassion, expertise, and experience to provide you with the Gold standard of advocacy. For more than 35 years, the team at Goldenberg Lauricella has helped clients injured by defective products obtain justice. Contact Goldenberg Lauricella today to learn how we can help you.