In the summer of 2022, the Food and Drug Administration released several notices of recalls related to “natural” supplements that contained the prescription medication tadalafil and its analogs, the active ingredients in Viagra and Cialis. The problem leading to the recall is two-fold. First, consumers were not made aware that these supplements contained a prescription medication, and second, according to the FDA, the medication has been shown to result in an increased risk of “heart attack, stroke, or death” in the target population.
If you took a “natural” male-enhancement supplement and subsequently experienced a heart attack or stroke, you may have a legal claim against the manufacturer of the product. If successful, you could recover meaningful compensation for everything you’ve been through, including your medical expenses, lost wages, and decreased quality of life. Not only that, but defective drug lawsuits also send a message to manufacturers of these supplements that they cannot continue to market potentially dangerous products. At the law firm of Console & Associates, P.C., we recognize the difficulties your family has gone through and want to help you make a difference. Our team of personal injury lawyers is actively investigating product liability claims against the manufacturers of supplements containing tadalafil. As a part of our investigation, we are scheduling free consultations for individuals who suffered serious health conditions as well as with family members who tragically lost a loved one as a result of taking these supplements. We can help you understand your rights and explain your legal options.
The Food and Drug Administration is the federal agency responsible for overseeing all over-the-counter and prescription medications, as well as natural supplements. While the FDA typically does not make any assurances about the veracity of the claims made by these manufacturers, the FDA maintains oversight to ensure that the products do not put consumers at undisclosed risks.
Most recalls are “voluntary” in that they are initiated by the manufacturer of a supplement or drug. However, these voluntary recalls often come as a result of FDA findings that the product is dangerous or contains undisclosed ingredients. If the FDA determines that a product is dangerous and the manufacturer fails to issue a recall, the FDA then has the power to issue a mandatory recall.
In the case of natural supplements, the FDA regulates these products as “food” products and not as medication. Thus, they are subject to less strict regulations. However, when a supplement presents undisclosed risks—if, for example, the supplement contains an undisclosed ingredient—the FDA retains the ability to issue a recall or remove the products from the shelf.
If you took supplements containing Tadalafil and were negatively affected, we can help.
FDA testing revealed 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 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 claim their supplements provide sexual enhancement and reproductive health benefits and include various herbal ingredients such as ginseng root, Tribulus Terrestris, and royal honey. Some of the products mentioned in the FDA warning letters also claim 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. Notably, none of these claims have been substantiated by the FDA. However, based on recent FDA studies, some of these supplements do contain tadalafil and its analogs.
Tadalafil is a prescription medication and the active ingredient in drugs such as Viagra and Cialis, both of which are intended to treat erectile dysfunction. Tadalafil is known as a vasodilator and works by relaxing the smooth muscle in the prostate and bladder. However, taking tadalafil can cause an interaction in patients who are also taking other medications, such as drugs used to treat:
Tadalafil, sildenafil and their analogs also have potentially dangerous interactions with several antibiotics, such as clarithromycin, erythromycin, and telithromycin.
For example, Tadalafil is known to interact with nearly 300 drugs. The FDA also lists nine “disease interactions” and one “alcohol/food interaction.” Of all the drug interactions, approximately 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.
Thus, there are many who purchased these supplements online or over the counter and have since experienced worsening symptoms or the development of new heart-related problems.
Yes, it is possible for anyone who experienced a heart attack, stroke or other serious health condition to file a product liability claim against the manufacturer of the supplement. Often, these claims are based on misleading claims made on the product’s label or, in this case, the inclusion of potentially harmful substances that were not mentioned on the product’s label.
However, claims against supplement companies present unique challenges because there is often very little data regarding the safety and efficacy 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.
Consumers who successfully bring a supplement lawsuit are entitled to damages intended to compensate them for 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.
Supplement manufacturers marketed and sold products without telling consumers that their supplements contained the prescription drug tadalafil, which can cause serious injury or death in some people who were not prescribed the drug. If you suffered a heart attack, stroke or other injury while taking a male-enhancement supplement containing tadalafil, the law firm of Console & Associates, P.C. can help you determine if you have a case against the manufacturer. At Console & Associates, P.C., we are actively investigating tadalafil supplement lawsuits on behalf of those who believe they were affected by these dangerous substances. If you are interested in learning more about pursuing a product liability claim, reach out to the experienced tadalafil supplement lawyers at Console & Associates, P.C., at 866-778-5500. We will attentively listen to your story, answer your questions, and offer you guidance about how you may be able to pursue a claim against the parties responsible for your preventable health condition. Console & Associates, P.C., will investigate your case at no charge and offer you thorough advice about how to most effectively proceed with your case. If you decide to bring a case, we only get paid if you do. If your claim is successful, any legal fees are either paid by the defendant or come out of the funds recovered from the defendant. If your claim doesn’t result in a recovery, you will pay nothing.