Is Your Cold Medicine Safe?

Selecting the right cold remedy is tough enough. You’re in the pharmacy aisle crammed with decongestants, cough suppressants, expectorants and multiple-action formulas. You see many formulas of each brand. Now, on top of everything else, a government warning has left you wondering if your favorite brand is safe.

Over-the-counter cough and cold products containing the active ingredient PPA (phenlpropanolamine) were yanked from pharmacy shelves, and many are being replaced with PPA-free products, leaving people even more stumped.

Novartis Consumer Health, makers of Triaminic® cough and cold formulations, found through numerous calls to its toll-free consumer affairs number that people are suffering from a case of cold-medicine confusion.

“In most cases, they (consumers) are seeing the same brand names they always used to see, but they are confused as to whether they’re reformulated,” Sheldon Jones, a spokesperson for Novartis Consumer Health said. “The best way to find out if a cold medication has been reformulated is to check the ingredient label. The reformulated medicines will contain pseudoephedrine instead of PPA.”

The government urged consumers not to take PPA-containing remedies, and manufacturers voluntarily agreed to stop selling such products because PPA had been linked to a slight increase of stroke in young women. Men also may be at risk.

Specifically, PPA was associated with hemorrhagic stroke, or bleeding into the brain, according to a five-year study by researchers at Yale University School of Medicine.

Although the risk of hemorrhagic stroke is very low, The Food and Drug Administration recommends that consumers not use any products that contain PPA.

PPA also is found in diet pills Dexatrim® and Acutrim®.

Reading labels carefully

Four reformulated Triaminic products, now PPA-free, are now widely available on pharmacy shelves: Triaminic Cough®, Triaminic Cold and Allergy®, Triaminic Chest Congestion® and Triaminic Cold & Cough®.

Before the reformulations, Novartis Consumer Health had discontinued some of the older labels of Triaminic, which contained PPA (Triaminic DM, Triaminic Syrup, Triaminic Expectorant, and Triaminicol).

Consumers are advised to check their medicine cabinets and, if they find these formulas, to discard them.

Whitehall-Robins, the consumer health care division of American Home Products Corporation, advises consumers of its two new reformulated Dimetapp formulas (Dimetapp Elixir® and Dimetapp DM Elixir®) to look for a yellow band on the front of the boxes. The band reads “New formula. Read directions carefully.”

The company’s Robitussin formulas do not contain PPA. Whitehall-Robins had previously reformulated its Robitussin CF® formula, the only product in the Robitussin line that contained PPA. Again, consumers are advised to look for the yellow band on the box.

Bristol-Myers Squibb, which is working to make its products PPA-free, makes Comtrex Flu Therapy and Fever Relief®; Comtrex Deep Chest Cold®; Naldecon DX®; Naldecon Pediatric Drops and Children’s Syrup®; Naldecon DX Adult Liquid®; and Naldecon EX Pediatric Drops and Children’s Syrup®.

Bayer-Consumer Care Division also is reformulating its Alka-Seltzer Plus® effervescent cough/cold products. Its Alka-Seltzer antacid/pain relief products do not contain PPA, according to the company.

Some drug company executives, including R. William Vander Haar, senior vice president, Bayer Global Scientific Affairs, OTC, were critical of the Yale study that prompted the removal of PPA from cough and cold products. Vander Haar noted that Alka-Seltzer Plus® had a 30-year safety record with no reports of hemorrhagic stroke associated with its use.

Pseudoephedrine, the active ingredient that is being used as a substitute for PPA, is not thought to be associated with an increased risk of hemorrhagic stroke. However, some of the same precautions apply to it as well as PPA. For example, neither drug should be used by patients with high blood pressure or thyroid disease, according to the information from the U.S. National Library of Medicine.

More questions about PPA?

For answers to questions about PPA-containing drug products, call the FDA toll free at 1-888-INFO FDA (1-888-463-6332).

Below also is list of hotlines that drug manufacturers have established for consumer questions about their cough and cold products:

  • Novartis Consumer Health, 1-800-452-0051
  • Whitehall-Robins Healthcare, 1-800-762-4675
  • SmithKline Beecham Consumer Healthcare (makers of Contac), 1-800-245-1040