Wyeth Recalls Cold Medicines, Lawmakers Urge FDA Action

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Wyeth Consumer Healthcare launched a voluntary recall and replacement program for US retail outlets that sell several ?Robitussin? and ?Children?s Dimetapp Cold and Chest Congestion? products.

Madison, NJ (Oct. 29)-Wyeth Consumer Healthcare launched a voluntary recall and replacement program for US retail outlets that sell several “Robitussin” and “Children’s Dimetapp Cold and Chest Congestion” products. The program will remove products with dosage cups that do not have a half-teaspoon mark. One-half teaspoon is the recommended dose for children aged two to under six.

Products being recalled and replaced include:

  • “Robitussin Cough DM”

  • “Robitussin Cough and Cold CF”

  • “Robitussin Cough and Congestion”

  • “Robitussin Chest Congestion”

  • “Robitussin Head and Chest Congestion PE”

  • “Robitussin Cough Sugar Free DM”

  • “Children’s Dimetapp Cold and Chest Congestion”

Wyeth says the recall program is not related to the drugs themselves. The company advises consumers not to use the products until replacements with new cups are available in early November 2007. Packaging for the replacement products will indicate that the new dosage cup is included.

In a related development, Senator Chris Dodd (D-CT) urged US Food and Drug Administration Commissioner Andrew von Eschenbach to ensure that the benefits of children’s medications outweigh their risks. Dodd, a senior Democrat on the Senate Committee on Health, Education, Labor, and Pensions and the chairman of its Subcommittee on Children and Families, made his request in a letter sent Oct. 31, following a joint meeting of FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.

At the meeting, the committees recommended that over-the-counter cold medicines for children under six years old be removed from store shelves because of safety concerns. Dodd found it “deeply troubling” that FDA officials advised parents to continue following the directions on the products, despite the committees’ findings. He called for “swift and comprehensive action” on the recommendations.

“The FDA’s own advisory committees found that while there was no evidence that over-the-counter cough and cold products were effective in children under the age of six, there was evidence that some children had been harmed, and have even died, from taking these products,” Dodd wrote.

Also, Rep. Henry Waxman (D-CA) introduced the Non-Prescription Drug Modernization Act on Nov. 6 to speed the process for banning drugs. The bill would allow FDA to skip notice and public procedure for amending or repealing monographs when an advisory committee finds that a drug poses a significant risk or lacks evidence of effectiveness.

For related stories, see:
FDA Committees Recommend Ban on Cough and Cold Medications for Young Children,
Drug Makers Voluntarily Recall OTC Infant Cough and Cold Medications,
and FDA to Discuss Pediatric OTC Drugs, Warns Against Codeine Use