FDA panel's vote puts chill on cold remedies

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A slew of well-known over-the-counter drugs are facing a public relations crisis that threatens to dent their brand images just as the key cold season begins.

Novartis Consumer Health's Triaminic, Bayer's Alka-Seltzer Plus, SmithKline Beecham's Contac, and American Home Products' Whitehall-Robbins' Robitussin and Dimetapp were among the brands thrown on the defensive when a government panel warned that a key ingredient in them may increase the risk of stroke.

Their product packages were splashed in color on the cover of The New York Times and lined up on the set of the "Today" show, no doubt raising concerns in the homes of millions of consumers.

Richard Nicolazzo, a Boston-based crisis communications expert, said a forceful, outreach-oriented industry response could bolster consumer confidence. He recommended the industry stress its emphasis on consumers' health and the long safety history of its products, while placing labels on products warning women 18 to 49 to consult physicians before use.

RISK OF `PERMANENT DAMAGE'

"If they respond in a responsible, proactive way, they will go a long way in building consumer confidence and brand loyalty," Mr. Nicolazzo said. "If they don't manage it the right way, they run the risk of causing permanent damage to these well-known, highly effective brands."

The Consumer Healthcare Products Association, an industry trade group, took issue with the U.S. Food & Drug Administration advisory panel's vote declaring the ingredient unsafe. The industry strongly defended the safety and efficacy of products containing phenylpropanolamine or PPA.

The panel's non-binding decision was based on an existing, industry-funded Yale University study that found PPA led to an increased risk of hemorrhagic stroke in women 18 to 49. "Whitehall-Robbins along with a lot of other marketers disagree with the assessment of the Yale University study and are disappointed in the outcome of the vote," an AHP spokesman said.

UNCLEAR WHEN FDA WILL ACT

It was unclear when the FDA, which will determine whether to ban PPA, would act on the panel's vote. The FDA typically follows the advice of its advisory panels, although a high-profile, heavily debated issue may influence the agency to move cautiously.

But the industry may be less affected by that future ruling than it will be in the short term as it grapples with how to blunt a potential public relations nightmare stemming from the panel's recommendation. A spokesman for AHP said the company has no plans to alter its advertising plans for Robitussin and Dimetapp. A Bayer spokeswoman said ads won't be pulled for Alka-Seltzer Plus, either. Other companies did not return calls by press time, and with the industry standing behind its products' safety, no recalls were expected.

The challenge for the industry is to avoid a situation similar to the disastrous ones that occurred in recent years involving two popular prescription treatments, American Home Products' fen-phen diet drug combination and Warner-Lambert's diabetes drug Rezulin. In both cases, the FDA forced the treatments off the market while the marketers faced abundant litigation for health problems the products may have caused.

The AHP spokesman said one case stemming from PPA's toxicity has been filed against the company, but he declined to discuss details. Last week's news could unleash a rash of lawsuits, which would only intensify media interest.

Even if the FDA ultimately bans PPA, companies could reformulate their products to include an alternate ingredient such as pseudoephedrine. AHP has already taken that step with Robitussin CF, the only product in the Robitussin franchise with PPA.

If the FDA outlaws PPA, Dimetapp will undergo a similar change. "We believe we can take out PPA, put in pseudoephedrine and still have a competitive brand on the shelves very quickly," the AHP spokesman said.

Contributing: Bonnie Tsui

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