Wyeth Recalls Cough And Cold Medicines With Faulty Dosage Cup

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Main Category: Pediatrics / Children's Health
Also Included In: Flu / Cold / SARS
Article Date: 30 Oct 2007 - 14:00 PDT

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Wyeth Consumer Healthcare in the US is recalling and replacing a range of Robitussin cough and cold medicines and Children's Dimetapp Cold & Chest Congestion medicine because the measuring cup does not show a half-teaspoon mark to help measure a dose for children aged two to six.

The company was keen to emphasize that there were no problems with the medicines themselves, it was only the plastic cup that was faulty.

Consumers are advised not to use these products for children aged two to six and to wait until the version with the correct cup is available, which should be in the shops early next month, November.

The new versions with the correct cup will have a clear mark on the packaging to show it contains the correct cup.

The recall affects only the following products:

• Robitussin Cough DM.
• Robitussin Cough & Cold CF
• Robitussin Cough & Congestion.
• Robitussin Chest Congestion.
• Robitussin Head & Chest Congestion PE.
• Robitussin Cough Sugar Free DM.
• Children's Dimetapp Cold & Chest Congestion.

The company urged parents not to give any of the above medicines to children without using the correct dosage cup.

Concerned parents should contact their healthcare professional about the best way to treat coughs and colds in children under 6.

Consumers can get more information by calling 1-800-762-4675 or visiting the Dimetapp.com and Robitussin.com websites.

This recall comes in the wake of a US Food and Drug Administration (FDA) advisory panel's advice that cough and cold medicines that have been sold over the counter for years should not be given to children under 6. They said the drug companies should carry out trials to prove the drugs work for children.

Many drugs have only been tested on adults, they said, and adult data is used to calculate safe dosage for children.

An expert in infectious diseases at the University of Chicago Children's Hospital, and member of the advisory panel, Dr Robert Daum said that current studies do not prove the drugs are effective for children.

The FDA said it will be looking at the advice. Pediatricians and public health officials have asked the FDA to restrict sales of over the counter cough and cold remedies for children, complaining that the drugs are not effective and can even harm young children.

The week before the FDA panel convened, drug companies voluntarily withdrew 14 products for children under 2. These included Dimetapp Decongestant Plus Cough Infant Drops and Robitussin Infant Cough DM Drops.

Written by: Catharine Paddock
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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