Beginning March 24, 2021, the Federal Drug Administration (FDA) began to issue a series of recall notices for “nutritional supplements for male sexual enhancement.” As of April 5, recalls have been published for 14 different brands. The brands recalled so far are listed in the box below. It is very likely that more, similar products will be recalled in the days ahead.
All of these products are advertised as “natural.” According to their labels, many contain imaginary ingredients like “horny goat weed.” All the recalled products contain undeclared ingredients including one or more of three prescription medications: the erection medicines sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra and Staxyn ODT.) Some of the products contain all three, in unknown amounts. These products are sold in retail stores, on the Internet, through eBay, and on Amazon.
There are many dangers of including prescription medicines in products sold over the counter (without prescription.) First, of course, it is illegal. Second, because it is illegal these ingredients can’t be listed on the labels. Third, because prescription medicines aren’t listed on the label, the amounts of the medicines in the pills are unknown.
There are practical reasons why some medicines require prescriptions. Medications can be dangerous, especially when used in high doses, when taken with other medications, or when taken by people with certain medical conditions. They can have dangerous side effects, which a person will not recognize if they don’t know what they have taken. For example, all three of the prescription erection medicines that are secretly included in these products lower blood pressure. For people taking a type of medicine called nitrates, which are prescribed for heart disease and high blood pressure, the combination of nitrates and erection drugs can cause blood pressure to drop so low that the person may have a stroke or even die. Since the presence of these drugs in non-prescription erection pills is not listed in the ingredients, people who take them have no way to know that side effects might happen. Also, men who buy over-the-counter pills may already be taking a prescription erection medicine: combining this with non-prescription pills can cause dangerously high blood levels of the medicines.
All three of the prescription erection medicines can cause long-lasting, painful erections which can continue for several days. It can be necessary to draw blood from the vein at the base of the penis to bring down the erection. These medicines can cause headaches and a blue tinge to the vision, which can be frightening and worrisome. They can cause fainting. These side effects cannot be assessed and managed when medical responders can’t get an accurate history of a patient’s medicines.
There are many reasons for erection problems. Some of them, like nerve damage and small blood vessel disease, are not helped by erection medicines. Many men with erectile dysfunction don’t know the cause of their problem. They may take dangerous amounts and combinations of over-the-counter and prescription medicines in unrealistic hopes of improvement.
How can prescription drugs get mixed into “nutritional supplements”? Unlike prescription medicines, which go through lengthy tests before they are approved for sale, products labeled as dietary supplements are not checked by any agency of the government or manufacturers. There are industry-sponsored laws that specifically exclude dietary supplements from FDA regulation. Nutritional supplements only become susceptible to action by the FDA if, as in this case, they’re found to contain drugs that are legal only by prescription. In the past, “dietary supplements“ marketed for weight loss have contained amphetamines and other dangerous, addictive prescription products. Bodybuilding supplements have contained steroid medications and compounds that caused kidney and liver damage.
When a nutritional supplement is labeled “all natural”, “organic”, or even just labeled “safe“, that doesn’t mean anything. There is no government or private agency that confirms these claims. There is no guarantee that the preparation even contains the ingredients listed on the label, or that it does not contain ingredients that aren’t listed.
For safety, it’s better to avoid all products labeled nutritional or dietary supplements, especially those manufactured outside the United States. If you believe you are deficient in a vitamin or mineral, the best way to make up the deficiency is by eating more foods that contain what you need. Vitamins and minerals in food are absorbed better then those in pills. If you do take a supplement, take only vitamins or minerals, not herbal products. Plants vary in chemical composition, depending on soil and weather. Plant products are often contaminated with other plants or substances.
Although I know some people don’t like to hear this, it’s also important to realize that products labeled “homeopathic” contain only water. These are a waste of money, but they are safer than many “nutritional supplements”!
- Eva Hersh is a family physician. Send your comments and questions to her by email at firstname.lastname@example.org