Ingredients can differ in look-alike drugs

Michael Cohen is president of the Institute for Safe Medication Practices in Horsham.

You may find it hard to believe, but the FDA has no say in the naming of many over-the-counter drugs. That's a great help to companies that sell drugs, but it has led to confusion and errors for consumers.

Here's why. Companies often use the same trusted brand name for a full line of products, even if the ingredients in each one are different. That happens with soaps and deodorants, but with OTC drugs - those sold without a prescription - people sometimes use the wrong drug, to their detriment.

So watch out if you're seeking Benadryl, Claritin or Zyrtec Eye Drops, Triaminic, Sudafed, Betadine, Surfak, Kaopectate, or AZO. They may not contain what you want.

Certain classes of OTC drugs are exempt from FDA review, including thousands that were already being sold in 1972, before the federal requirement that all drugs be approved. Companies that make drugs "generally recognized as safe and effective" by the FDA - acetaminophen is one - do not have to submit a new drug application before marketing them over-the-counter.

So, some products in your drug or grocery store do not have their product names approved by the FDA. Drug companies can capitalize on a well-known, trusted brand name, and use it for any variation of that product. It's known as "brand-name extension." Unless the FDA learns of errors that cause harm to patients, there's not much the agency can do about it.

We hear off and on from consumers who realize many OTC drugs are not what they seem.

A good example is the man whose gastroenterologist ordered the strong laxative Dulcolax to help clear his bowels before a colonoscopy. The patient bought a bottle of Dulcolax and took it as his doctor ordered. Unfortunately, he bought a bottle of Dulcolax with the stool softener docusate, not the strong laxative bisacodyl that his doctor wanted him to take. Both products go by the name Dulcolax. The colonoscopy could not be done.

A similar situation is about to unfold with two new "Allegra" products. They do not contain the active ingredient of the original Allegra product used to treat allergies. The new products, Allegra Anti-Itch Cooling Relief and Allegra Anti-Itch Intensive Relief, contain diphenhydramine and allantoin and are applied to the skin. You may know diphenhydramine by another name - the allergy drug Benadryl. The only thing these new products share with the original Allegra is the brand name and the "look" of the packages. The original Allegra contains a drug called fexofenadine, a non-sedating antihistamine.

The company that makes these "Allegra" products, Chattem, part of pharma giant Sanofi, is using a design from the original Allegra - including the purple-colored cartons and stylized Allegra name. The similarities raise the risk of confusion.

Someone taking another allergy or sleep drug also with diphenhydramine can develop hallucinations, high body temperature, a fast heart rate, and convulsions, needing hospitalization. Also, people who are allergic to diphenhydramine may not realize they should avoid the new products. Many dermatologists do not like to apply diphenhydramine to the skin because it is sensitizing and could lead to contact dermatitis.

When buying any OTC medicine, don't rely only on brand names. Read the package label carefully, especially the Drug Facts label on the side or back. The top of this label lists the active ingredients. Be sure the product includes the ingredient you need. If you are unsure, ask your pharmacist for help.