In recent months, the Food and Drug Administration (FDA) has announced several recalls related to natural supplements containing tadalafil and its analogues, the active ingredients of Viagra and Cialis. In its recall notice, the FDA notes that these natural supplements put consumers at risk because tadalafil can cause “heart attack, stroke, or death” in patients for whom the drug was not prescribed.
If you have taken “natural” branded supplements and then suffered a heart attack or stroke, your condition may have been caused by the tadalafil in the drug. Unfortunately, the makers of the recalled supplements did not inform consumers that their product contained a potentially dangerous drug, which puts you at increased risk. To learn more about the possible adverse health consequences of tadalafil-containing supplements, please see our recent article on the subject. here.
What is a supplement reminder?
Pharmaceutical companies generate trillions of dollars in profits each year from prescription, over-the-counter (OTC), and herbal supplements. While the FDA imposes strict regulations on pharmaceutical companies and drug manufacturers, many over-the-counter and herbal supplements enter the market with little quality control or oversight. This is mainly because many herbal supplements are regulated as foods, not drugs, under the Dietary Supplements Regulation Act (DSRA).
Under the DSRA, these products are subject to less stringent rules than the FDA. The FDA does not evaluate these products for safety, efficacy, or labeling. The FDA can remove supplements from the consumer stream if it finds the product to be unsafe or mislabeled. However, many products go unnoticed and as a result, consumers are at serious risk of injury or death by consuming potentially dangerous supplements.
When the FDA becomes aware of a drug or supplement that poses undisclosed risks to consumers, it can issue a mandatory recall. However, in most cases, under pressure from the FDA, companies choose to issue “voluntary” recalls instead.
Do natural supplements contain tadalafil?
Yes, FDA lab testing found several samples of honey supplements contained active ingredients that were not listed on the product labels. In July, the FDA cited four companies for illegally selling these products without disclosing that the supplements included tadalafil and sildenafil, marketed as Cialis and Viagra, respectively.
The FDA sent warning letters to:
Other companies, such as Loud Muscle Science, LLC and Ultra Supplement, LLC issued voluntary recalls after reporting that their dietary supplements were contaminated with tadalafil.
These companies boasted that their supplements provided sexual enhancement and reproductive health. The products claim to include various herbal ingredients such as Ginseng Root, Tribulus Terrestris, and Royal Honey. Some of the products mentioned in the FDA warning letters claimed to cure, alleviate, treat, or prevent medical conditions. Additionally, some products treat illnesses and conditions that can only be diagnosed or treated under medical supervision.
Is tadalafil linked to heart problems?
The FDA approves tadalafil and sildenafil as drugs used to treat men with erectile dysfunction. However, consuming a supplement containing undisclosed amounts of tadalafil or sildenafil has many negative and life-threatening consequences. Accordingly, this is why tadalafil is a prescription drug, and those taking tadalafil should do so under the care and supervision of a licensed healthcare professional.
Tadalafil is known to interact with nearly 300 drugs, nine disease interactions, and one alcohol/food interaction. Of all drug interactions, approximately 185 are moderate to major. The most profound consequence of unintentional tadalafil use involves life-threatening hypotension resulting from the interaction between tadalafil and certain heart medications.
Additionally, people with cardiovascular disease, kidney dysfunction, lung disease, priapism, alcoholism, hearing loss, liver disease, retinitis pigmentosa, or seizure disorders are at increased risk of injury when they consume tadalafil.
Can consumers sue herbal supplement companies?
Yes, claims against pharmaceutical companies and supplement manufacturers often arise after a consumer has suffered injury from a defective or unsafe product. Companies can be held liable for defects in the design or manufacture of their product, misleading marketing, and failure to adequately warn customers of a drug’s side effects. Additionally, online and physical retailers may be liable for the sale of these products.
Claims against supplement companies present unique challenges because there is little data regarding the safety and effectiveness of most of these products. Thus, injury victims may encounter difficulties in establishing the causal link between their injuries and the product. This is why the majority of lawsuits against herbal supplement manufacturers fall under national consumer protection laws alleging that the company engaged in misleading advertising or labeling.
Those who achieve favorable results through settlement, litigation, or appeal may obtain damages related to their injuries and illnesses. Compensation from a successful lawsuit against a supplement company can include payments for medical treatment, lost wages, pain and suffering, and emotional distress.
People who have had a heart attack or stroke after taking a “natural” supplement containing tadalafil may have a legal action against the manufacturer of the product. Additionally, those who have lost a family member to a heart attack or stroke may be eligible for compensation through a wrongful death lawsuit. Those who have suffered harm from supplements containing tadalafil should consult with a knowledgeable product liability attorney to learn more about their rights.