In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its notice of recall, the FDA notes that these natural supplements put consumers at risk because tadalafil may cause “heart attack, stroke or death” in patients for whom the medication was not prescribed.
If you took supplements that were branded as “natural” and subsequently suffered a heart attack or stroke, your condition may have been caused by the tadalafil contained in the medication. Unfortunately, manufacturers of the recalled supplements failed to notify consumers that their product contained a potentially dangerous drug, putting you at an increased risk. To learn more about the possible adverse health consequences of Tadalafil-containing supplements, please see our recent post on the topic here.
What Is a Supplement Recall?
Pharmaceutical companies generate trillions of dollars in profits every year from prescription, over-the-counter (OTC), and herbal supplements. While the FDA imposes strict regulations on pharmaceutical companies and drug manufacturers, many OTC and herbal supplements enter the market with little quality control or oversight. Primarily, this is because many herbal supplements are regulated as food, not drugs, under the Dietary Supplement 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, effectiveness, or labeling. The FDA can remove supplements from the consumer stream if they discover that the product is unsafe or misbranded. However, many products fly under the radar and as a result, consumers face a severe risk of injury or death from consuming potentially dangerous supplements.
When the FDA learns of a medication or supplement that presents undisclosed risks to consumers, it can issue a mandatory recall. However, in most cases, under FDA pressure, companies instead opt to issue “voluntary” recalls.
Do Natural Supplements Contain Tadalafil?
Yes, FDA laboratory testing discovered that several samples of honey-based 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, respectively marketed as Cialis and Viagra.
The FDA issued 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 tainted with tadalafil.
These companies boasted their supplements as providing 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, mitigate, treat, or prevent medical conditions. Further, some products address diseases 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 experiencing erectile dysfunction. However, there are many negative and potentially life-threatening consequences of consuming a supplement tainted with undisclosed amounts of tadalafil or sildenafil. Accordingly, this is why tadalafil is a prescription medication, and those who take tadalafil must do so under the care and supervision of a licensed medical professional.
Tadalafil is known to interact with nearly 300 drugs, nine disease interactions, and one alcohol/food interaction. Of all the drug interactions, about 185 are moderate to major. The most profound consequence of unintentional consumption of tadalafil involves life-threatening hypotension resulting from the interaction between tadalafil and certain heart medications.
Additionally, those experiencing cardiovascular disease, renal dysfunction, pulmonary disease, priapism, alcoholism, hearing loss, liver disease, retinitis pigmentosa, or seizure disorders are at heightened risk of injury when consuming tadalafil.
Can Consumers Bring a Claim Against Herbal Supplement Companies?
Yes, claims against pharmaceutical companies and supplement manufacturers often arise after a consumer suffers injuries from a defective or dangerous product. Companies may be held liable for defects in the design or manufacturing of their product, deceptive marketing, and failure to adequately warn customers about a drug’s side effects. In addition, online and brick-and-mortar retailers may be liable for selling these products.
Claims against supplement companies present unique challenges because minimal data exists regarding the safety and efficacy of most of these products. As such, injury victims may face hurdles in establishing the causal connection between their injuries and the product. That is why the majority of lawsuits against herbal supplement manufacturers fall under state consumer protection laws alleging claims that the company engaged in deceptive advertising or labeling.
Those who achieve favorable outcomes through settlement, litigation, or appeal may secure 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.
Individuals who suffered a heart attack or stroke after taking a “natural” supplement that contains tadalafil may have a legal case against the manufacturer of the product. Additionally, those who lost a family member as a result of a heart attack or stroke may be entitled to compensation through a wrongful death lawsuit. Those who experienced the harms of supplements containing tadalafil should consult with a knowledgeable product liability attorney to learn more about their rights.
