By Michael R. Cohen: president of the Institute for Safe Medication Practices
A young mother went to her local pharmacy the other day to find medications for her small children, who were suffering from bad colds. In the cough and cold section, she saw a bottle of Triaminic liquid and decided to buy it, remembering Triaminic as a cold medicine. She also picked up a bottle of store brand acetaminophen, the main ingredient in Tylenol, for their fever and sore throats.
Without knowing it, she actually had two bottles of acetaminophen in her hands. Fortunately, a pharmacist was watching her and wondered why she would buy both products. Had he not intervened, she probably would have given both to her children, possibly harming them if she gave them too much acetaminophen over a long period, which has been shown to cause liver damage.
Mom had no idea that both medicines contained the same ingredient. She just knew that she wanted her kids to have acetaminophen for their sore throats and Triaminic for their cold symptoms. The statement on the box about the Triaminic being a fever reducer and the yellow highlighted “acetaminophen” (see photo) did not prevent her mistake, and did not signal that this Triaminic was different than the one she’d come to know.
This version of Triaminic is one of several brands of plain acetaminophen that have become available in recent months as a result of problems that Johnson and Johnson has had with supplying its acetaminophen product, Tylenol, due to manufacturing problems. The brand name “Triaminic” has been around for many years as a decongestant-antihistamine combination, so probably many other consumers also think of it as a cold medicine.
The children in the story nearly fell victim to a potentially dangerous situation that exists with many “over-the-counter drugs” (ones sold on grocery store or pharmacy shelves without a prescription). It’s one that the public is largely unaware of, and it has led to confusion and medication errors made by consumers. Companies often use the same trusted brand name for an entire line of products, even if the ingredients in each product are completely different. They can do it legally too. So watch out if you’re searching store shelves for Benadryl, Claritin or Zyrtec Eye Drops, Sudafed, Betadine, Surfak, Kaopectate, Dulcolax or AZO. What is in these products may not be what you expect.
Drug companies that want to sell a prescription medication over-the-counter (OTC) have to have it approved again as a new drug by the Food and Drug Administration (FDA). However, certain classes of OTC medications are exempt from FDA review, including thousands already on the market in 1972 prior to the Federal requirement that all drugs be approved. Companies that make medications “generally recognized as safe and effective” by FDA—and acetaminophen is among them—do not have to submit a new drug application before marketing them over-the-counter.
So some products available in your drug or grocery store, like Triaminic Fever Reducer, do not have their product names approved by FDA. Drug companies can capitalize on a well-known, trusted, brand name, and use it for any variation or formulation of that product. It’s known as “brand name extension.” Unless the FDA learns of errors that might cause harm to patients, there’s not much the agency can do about it.
Over the years, the Institute for Safe Medication Practices has received a number of reports of consumers or health professionals such as emergency room doctors being confused or misled by over-the-counter drug names, assuming that the brand extension product had the ingredients of the original brand. Imagine a doctor thinking you accidentally overdosed on one drug, when it was really a different medication altogether!
It’s surprising Triaminic’s manufacturer, Novartis, decided to create this brand extension product, given that the FDA alerted the public last year about the potential for serious side effects with another of its over-the counter drugs. The FDA warned that consumers were mistakenly using Maalox Total Relief, which contained bismuth subsalicylate, instead of other Maalox products that contain magnesium and aluminum hydroxides. The agency received five reports of harmful medication errors in patients unknowingly taking the bismuth subsalicylate product, which shouldn’t be used in aspirin allergic patients. According to a February 18, 2010 Wall Street Journal article, Novartis decided to withdraw the Total Relief product from the market rather than change its name.
The FDA’s action seems to have implications for manufacturers of current and future FDA approval-exempt drugs seeking to create brand name extensions. Many safety experts outside of FDA, including my colleagues and I at the Institute for Safe Medication Practices, believe that brand name extensions present a safety concern and should not be used unless at least one ingredient from the original product is present in the new or modified product.
Finally, keep in mind that over-the-counter medications are required to have an approved “Drug Facts” label to educate consumers. Since the entire product ingredients are listed, make sure to read the label to prevent medication errors that could be harmful to you or your family.
For more on ISMP’s consumer website, go www.consumermedsafety.org.