Infant Cold Products Pulled; Waxman Looks For More OTC Risks

Manufacturers of OTC cough/cold medicines for children under 2 years old are voluntarily withdrawing the products from the market due to potential misuse, not from product safety concerns, the Consumer Healthcare Products Association said Oct. 11.

The move affects only infant oral medicines, not products intended and labeled for use in children age 2 and older. The withdrawal includes infant products from McNeil Consumer Healthcare's Tylenol and PediaCare brands, Novartis Consumer Health's Triaminic line, Prestige Brands' Little Colds line and Wyeth Consumer Healthcare's Dimetapp and Robitussin lines.

CHPA's announcement comes after House Committee on Oversight and Government Reform Chairman Henry Waxman, D-Calif., submitted questions to the association on Oct. 3 about the safety and efficacy of pediatric cough/cold products, particularly asking why the industry had not already removed products for children under 2 from the market.

Waxman contacted CHPA after FDA published reviews the Center for Drug Evaluation and Research compiled for a joint meeting Oct. 18 and 19 of the Nonprescription Drug and Pediatric advisory committees on the safety and efficacy of OTC antitussive, expectorant, nasal decongestant, antihistamine and combination cough/cold products in children under 6 years old (¹ (Also see "FDA Floats Eliminating Multi-Ingredient Pediatric Cold Products" - Pink Sheet, 1 Oct, 2007.), p. 3).

In CHPA's Oct. 11 reply to Waxman, group President Linda Suydam says the product withdrawal "is consistent with our industry's recommendation" to FDA to require labeling for all cough/cold OTCs to indicate "do not use" for children under 2.

"The challenge before us is to reduce the misuse of safe medicines. Although labels have always directed parents and caregivers to ask a doctor before using cough and cold medicines for children under 2, we believe a simple 'Do Not Use' statement is needed to help prevent overdose and misuse," Suydam said.

"When there is no evidence that these products actually work, combined with a great deal of evidence that they can harm kids," product withdrawal "is the only decision that makes sense," said the congressman, one of Capitol Hill's most frequent FDA critics.

Tip Of The Iceberg?

However, in an e-mail to "The Tan Sheet" Waxman reiterated his doubts about cough/cold products for older children as well as about other OTC drugs.

"I am also concerned that these products may not be effective for children up to 6 years old and I am relieved that the FDA's advisory committee will look at that issue," Waxman said.

"I fear, however, that these products are not the only over-the-counter drugs on pharmacy shelves that may not work as well as advertised, and may pose risks to consumers."

Waxman has asked FDA to convene NDAC to re-evaluate the effectiveness of phenylephrine as a nasal decongestant (² (Also see "Citizen Petition On Phenylephrine Requests Pulling OTC Status For Children" - Pink Sheet, 12 Feb, 2007.), p. 3).

Making Lemonade

McNeil is accompanying the withdrawal with communications stressing the safety of its products, on its Web site and in print ads.

The message stresses the safety of the products, and that the withdrawal is intended to prevent misuse. "These medicines are generally recognized as safe and effective when used as directed. Most parents use these cough and cold medicines appropriately," language on the site states.

The site also provides advice for parents about careful dosing.

Noting the withdrawal's potential inconvenience to customers, the firm is providing coupons for other McNeil products.

Novartis and Wyeth provide similar information on their Triaminic and Robitussin sites. Wyeth includes clarifications about the upcoming NDAC meeting designed to counter media reports that mischaracterized FDA's briefing documents about pediatric cold products.

A Group Decision

Wyeth stopped producing its two Dimetapp products for children under 2 - Decongestant Plus Cough Infant Drops and Decongestant Infant Drops - at the end of 2006, said Doug Petkus, a spokesman for the Madison, N.J.-based firm.

"I surmise that the inventory for those two products is limited right now," he told "The Tan Sheet."

Petkus added "the sales impact is minimal" from pulling the two Dimetapp products and Robitussin Infant Cough DM Drops from the market.

Wyeth also is re-labeling its OTC pediatric cough/cold medicines to advise caregivers to consult physicians before administering the products to 2- to 6-year-old children, according to comments it submitted to FDA Oct. 3 (see ³ (Also see "Wyeth To Add “Consult a Doctor” For Cough/Cold Use By Children 2 To 6" - Pink Sheet, 15 Oct, 2007.) ).

Wyeth was not concerned that regulatory action would be started to force firms to remove OTC cough/cold medicines for children under 2 years old from the market if the products were not voluntarily removed, Petkus said.

"I think the industry is trying to ensure the safe and effective use of these products in children. This was the population that was the most vulnerable to misuse of these products," he said.

Prestige Brands spokesman Dean Siegal noted, "We've all worked together and in conjunction with CHPA to come to this conclusion." The Irvington, N.Y.-based firm's Little Colds Decongestant Plus Cough and Multi-Symptom Cold Formula products account for around 1 percent of its annual net income, Siegal said.

Novartis Consumer Health also stressed the withdrawal was "an industry-wide move and it's a precautionary measure," said Terry Boylan, the Parsippany, N.J.-based firm's vice president for communication.

Each of the firms and CHPA are contacting retail stores and other businesses to inform them of the product withdrawals and asking them to stop selling the products.

CVS Caremark Corp.'s CVS/pharmacy chain announced it will remove the products from its stores and will install a blocking mechanism in its point-of-sale system to prevent sales of the items. Other retailers are removing the products as well.

- Malcolm Spicer ([email protected])