Drug Labeling: Formula for Disaster?
Temples pounding, you head to the drugstore for aspirin.
Rather than buy house-brand pills, you decide on a jazzier option: Bayer Select Headache Pain Relief Formula. Sounds like just what you need.
But then you read the label and find that there’s no aspirin at all in it, even though “Bayer” and “aspirin” are synonymous to many people. Instead, the active ingredients are acetaminophen (also found in Tylenol) and caffeine. So you grab a package of Bufferin. But choose Bufferin AF (for “Aspirin-Free”) and you’ve got acetaminophen again.
This practice of pairing new formulas with a well-known brand name--even if the new ingredients are very different than those in the original formula--is known in the drug industry as “line extension.” And it’s becoming more common for over-the-counter drugs--to the point, critics say, of being potentially dangerous.
Nonsense, say drug manufacturers. They claim that most consumers read a label before taking new medicine and that buying a familiar brand name is reassuring.
History
“Line extension has been going on since the late 19th century,” says Ira Bachrach, president of NameLab Inc., a San Francisco firm that names drugs and other products. In the beginning, says Bachrach, it was a common sense, functional practice. The maker of Cough Syrup, for example, adds raspberry flavoring and names the variation Cough Syrup II.
The Controversy
The practice has sparked debate recently in the pages of medical and pharmacy journals:
* Chlor-Trimeton, marketed for years as an antihistamine, was named to reflect the main ingredient, chlorpheniramine maleate, writes Michael T. Rupp, associate professor of pharmacy at Purdue University in the publication American Pharmacy.
But next came Chlor-Trimeton Non Drowsy formula, marketed as a non-sedating alternative to help allergy symptoms. People think the sedative effects were removed, Rupp says, without changing ingredients. Not so. The new formula has pseudoephedrine, a decongestant, but no antihistamine.
The new Chlor-Trimeton label was also criticized in a recent letter to the New England Journal of Medicine. The non-drowsy formula, if mistaken for the original product, might cause adverse reactions in people with underlying conditions such as coronary artery disease, writes Dr. Stephen J. Levine and pharmacist Terri Barton of the University of Oklahoma.
But in a response, Schering-Plough Health Care Products, the manufacturer, points out that both products are clearly labeled, with warnings about who shouldn’t use the drugs.
* Robitussin cough syrup products have also sparked criticism. The names of many Robitussin products “differ only by two-letter extensions to the root,” Rupp says. There’s Robitussin PE, DM and CF. (PE stands for the decongestant pseudoephedrine, DM for the suppressant dextromethorphan and CF means complete formula, says a spokeswoman for A.H. Robins, the manufacturer.)
There is no single active ingredient common to all Robitussin products, Rupp says. “Thus, consumers who select a Robitussin product without deciphering the ingredient/activity code cannot be sure of receiving any particular therapeutic benefit.” A.H. Robins counters that it advises consumers to ask their doctor or pharmacist which product is best.
Label Flagging
“Line extensions are part of the business,” insists Frank Rathbun, spokesman for the Nonprescription Drug Manufacturers Assn. in Washington. Voluntary guidelines, adopted by the association in 1977, include a “flag-the-label” recommendation, he says. When a product is changed, the information should be conveyed prominently on a label for six months, the guidelines say.
OTC Confusion
With labels flagged or not, consumers who buy over-the-counter products are confused, reports Jack Levenberg, a pharmacist at the Burbank Tower Pharmacy. The practice of line extension “has gotten progressively worse since I graduated (pharmacy school) in 1964,” he says. Not a day goes by, he adds, that he is not asked to explain some difference between over-the-counter medicines.
What’s in a Name?
“A trade name’s a trade name,” says Christopher Lomax, director of pharmacy and purchasing services at Childrens Hospital Los Angeles, who says line extensions have gone too far. “They come in, grab Tylenol and they are out of here.” But Tylenol now has about 23 dosage forms, says a spokesman for the manufacturer.
Keeping Tabs
Since there is no formal reporting requirement of adverse reactions with over-the-counter drugs, says a Food and Drug Administration official, there’s no way to tally how much confusion--or how many health problems--could result from the line extension trend.
“Of all adverse effects that occur with drugs, both over-the-counter and prescription, we estimate we learn of about 1% of them,” says David Barash, acting chief of the FDA’s reports evaluation branch.
That might improve soon, he adds, with the debut in June of MEDWatch, a federal program established to encourage physicians, pharmacists and other health-care professionals to report adverse effects of drugs, medical devices, dietary supplements, infant formulas and other products.
