A potentially dangerous drug has been yanked from the market, after testing by the government revealed potential risks involving ingredients that were unlisted on the label.
Our product liability attorneys know that companies have a responsibility to let consumers know what is in the products they are selling so that buyers can make informed choices. Failure to do so may result in product liability lawsuits.
In this case, the drug in question is X-Rock, a drug that was approved by the Food and Drug Administration for treatment of erectile dysfunction. News outlets are reporting that when the FDA tested the drug, it found two substances that weren’t on the label – sildenafil and hydroxythiohomosildenafil. The problem with these substances is that when they interact with other prescription drugs, like nitroglycerin, a person’s blood pressure can be reduced to a dangerous level.
This is especially concerning because men who are likely to have issues with erectile dysfunction are also more likely to have diabetes, high cholesterol, heart disease and high blood pressure. For each of these conditions, they are generally more likely to have been prescribed medication with nitrates.
In addition to the possibility of negative drug interactions, those two substances have been associated with a wide range of side effects, including flushing and headaches.
Both the FDA and the company claim they haven’t received any reports of problems as a result of taking the drug, and that this was a precautionary measure. However, the problem of reporting in this case may be two-fold.
For one thing, individuals who suffer from these other conditions may have mistaken any adverse side effects as being solely related to their original condition. And secondly, even if they suspected that X-Rock was to blame, erectile dysfunction is a sensitive issue. They may fear that a complaint or product liability lawsuit may make their information public. Fearing ridicule, they may have simply kept quiet.
What’s especially troubling about this recall is that, first of all, the drug was approved by the FDA before testing found these undeclared ingredients. And secondly, advertising for the product indicates that the drug, made in the U.S., is “totally organic.” It claims that the active ingredients are derived from potent natural ingredients and are totally void of steroids or chemicals.
Clearly, that’s not the case.
Much of the company’s profit appears to be derived from Internet sales, although there were reportedly retail locations in Florida, New York, California, Nevada, South Carolina, New Jersey and other states.
Those who have been using the X-Rock product should stop immediately, and talk to your doctor if you have experienced any of these problems. The FDA is asking that anyone who suffered negative side effects as a result of taking this drug to report it to the agency’s MedWatch Safety Information and Adverse Event Reporting Program at Maker recalls ‘X-Rock’ male supplement, Wire Staff, CNN
If the complications you have experienced as a result of using this drug were severe, you should contact a knowledgeable product liability attorney, who can help you determine whether you may have grounds for product liability litigation.
The Ferraro Law Firm represents people injured by recalled or defective products throughout the country. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami, Washington, D.C., and New York City.
Maker recalls ‘X-Rock’ male supplement, Wire Staff, CNN