Empty Shelves: What’s Behind the OTC Recalls?

The FDA has declared war on over the counter (OTC) medications, with the main targets being cold and fever medications, dietary supplements, and antacids. With OTC products increasingly harder to find, it’s up to pharmacists to fill the gap for consumers and help them find replacement products that meet their needs.

The FDA recalls started in 2009 and show no sign of abating. The main concerns center on medication quality, like the manufacturing issues at McNeil that had pharmacies yanking product, including children’s Tylenol and Rolaids, off the shelves. But tainted medications are not the only concern. The FDA is also targeting products with active ingredients that are not listed on the label. This has turned out to be a common case with dietary supplements, sexual enhancing supplements, and weight gain products.

According to Pharmacy Today, more than 70% of the supplements recalled between 2007 and 2009 were targeted due to undisclosed active ingredients. While the FDA does not require the same rigorous trials and testing for supplements as for prescription meds, they are manufacturing and labeling standards in place to ensure consumer safety.

In the last few years, the FDA has identified nearly 300 dietary supplements as tainted and potentially dangerous. Typically, undisclosed ingredients may include such potential dangers as anticoagulants, anticonvulsants, NSAIDS, beta blockers, and even fenfluramine and anabolic steroids…ingredients that are potentially fatal to some consumers, especially those also taking prescribed medications.

FDA Commissioner Margaret A. Hamburg, M.D., issued the following statement: “These tainted products can cause serious adverse effects, including strokes, organ failure, and death. The manufacturers selling these tainted products are operating outside the law.”

Public perception of OTC medications is that they are safe, but the FDA is rapidly proving that to be a false assumption in an alarming number of cases. As pharmacists, we may be the consumer’s best hope of learning the potential dangers of supplements, which is why it is so vitally important to establish rapport and a level of trust with customers. It is not our job to pass judgment, but if we can advise the customer to consult a doctor before taking any kind of OTC supplement and educate them to the potential dangers of drug interactions, then we have put one more brick in the path to good health.

The FDA also advises that consumers avoid products that claim to be legal substitutions for anabolic steroids, products marketed through spam email campaigns, and sexual enhancement supplements.

Pharmacists can help educate the public by stocking shelves with products from trusted manufacturers and doing product research before selling the products. Avoid the appearance of endorsement by stocking only products you feel confident endorsing. Know what’s on your shelves. To avoid legal and ethical violations, you should also be up-to-date on recall information. It’s important to know why the products were recalled and what substitutes are available. If they return to the shelves, it’s important to know what changed to ensure product safety. Here is a link to the FDA list of recalls, market withdrawals, and safety alerts.

Let us know how you advise your customers about recalled products and what substitutes you feel comfortable recommending.