An over-the-counter male enhancement supplement sold under the brand name Adam’s Secret, which was advertised as being “all-natural”, is now being recalled as unapproved drugs by the FDA.
The company-written, FDA-posted recall announcement said, “Adamssecret.co is voluntarily recalling all lots within expiry of Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 300 Capsules to the consumer level.”
Adam’s Secret Revealed
The pills were sold as a drug-free alternative to prescription medicines for male performance issues. But as it turns out, that is not the case at all.
Products being sold and advertised as something else is not a new bait created by drug manufacturers.
In fact, Johnson & Johnson was once investigated by federal authorities for the illegal marketing of their antipsychotic medication, Invega.
Turns out, even if the drug only got an approval for adult use, the company marketed it as safe even to vulnerable populations like children and the elderly.
Patients who took the medication suffered from a wide array of adverse effects like gynecomastia or the abnormal growth of breast tissues in men, and worsening diabetes and pneumonia in the elderly, and that’s just to name a few side effects.
These individuals are now filing Invega lawsuits to seek compensation for their pain and suffering.
And in the case of this supplement that was recently recalled, the U.S. Food and Drug Administration actually found what Adam’s Secret really is.
After an FDA laboratory analysis found that the product contains undeclared sildenafil and/or tadalafil, that’s when the recall was initiated.
This fact about the product made the capsules “unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.”
Sildenafil is the active ingredient in Viagra and Revatio, while tadalafil is the active ingredient in Cialis.
Why Is This Such A Big Deal?
First, what’s puzzling is that the supplement says it’s an “all-natural” solution to male performance issues. But as it turns out, it actually contains prescription-grade erectile dysfunction drugs in it.
The FDA adds through its announcement, “Consumers with underlying medical issues who take Adam’s Secret Extra Strength 1500 or Adam’s Secret Extra Strength 3000 capsules with undeclared sildenafil and tadalafil may experience serious health risks.”
Sildenafil and tadalafil are two ingredients which are included in the family of drugs known as phosphodiesterase (PDE-5 inhibitors).
They are also present in FDA-approved products for the treatment of male erectile dysfunction.
And there’s a very good reason why these types of products, like Viagra and Cialis, are available via prescription only.
They carry some risks and side effects that could be very harmful for people who are vulnerable to these drugs.
This is why many individuals who are at risk of complications from taking products like Viagra resort to taking “all-natural” supplements instead.
But in this case, people just ended up taking the drugs they were trying to avoid in the first place for the sake of their safety.
These PDE-5 inhibitors may interact with nitrates found in some medications like nitroglycerin. This interaction may be harmful as it could lower blood pressure to dangerous levels which could end-up as life-threatening.
Particularly, patients with high blood pressure, diabetes, or heart disease often take prescription drugs containing nitrates.
What You Can Do
Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules are packaged in blister foil sheets and a box containing 10 capsules.
The supplements were sold nationwide in the United States and were also made available at Amazon and other large online retailers.
Adamssecret.co is now taking the necessary steps to notify its customers through email and is arranging for the return of all affected products.
Consumers are advised by the FDA to return the capsules to wherever they were purchased. Those with questions related to the recall of this product can also email the company at firstname.lastname@example.org.
Also, if you have experienced any problems related to the use or taking of these products, you may contact your healthcare provider.
You can also let the Food and Drug Administration know of any adverse reactions through its MedWatch Adverse Event page.