Wyeth recalls kids' cough & cold drugs

2 November, 2007

Wyeth Consumer Healthcare, based in the United States, has recalled and will replace an array of its ‘Robitussin’ cough and cold medicines and Children’s Dimetapp Cold & Chest Congestion medicine.

The move came about after it was found that the measuring cup does not show a half-teaspoon mark to help measure a dose for children aged 2 to 6 years.

In a statement, Wyeth Consumer Healthcare, however, stressed that there were no problems with the medicines themselves and that it was only the plastic cup that was faulty.

The company has advised consumers not to give the products that have been recalled to children aged 2 to 6 years and instead wait till the version with the correct cup is available, possibly in early November 2007.

The new versions of the drugs with the correct cup will have a clear mark on the packaging to show that it contains the correct cup, the company statement said.

The products recalled by Wyeth Consumer Healthcare are Robitussin Cough DM, Robitussin Cough & Cold CF, Robitussin Cough & Congestion, Robitussin Chest Congestion, Robitussin Head & Chest Congestion PE, Robitussin Cough Sugar Free DM, and Children’s Dimetapp Cold & Chest Congestion.

The company has 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 six.

Consumers can find more information on the websites Dimetapp.com and Robitussin.com.

The recall of Wyeth Consumer Healthcare’s ‘Robitussin’ cough and cold medicines and Children’s Dimetapp Cold & Chest Congestion medicine comes in the wake of an advice by the United States Food and Drug Administration’s (FDA) advisory panel that cough and cold medicines that have been sold over the counter for years should not be given to children under 6.

The FDA advisory panel said the drug companies should carry out trials to prove that the drugs work for children.

According to the advisory panel, many drugs have only been tested on adults and that adult data is used to calculate safe dosage for children.

According to FDA sources, Dr Robert Daum, an expert in infectious diseases at the University of Chicago Children’s Hospital and a member of the FDA advisory panel, has said that current studies do not prove that the drugs are effective for children.

Many pediatricians and public health officials across the United States 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 be injurious to young children.

A week before the FDA advisory panel had convened, drug companies had voluntarily withdrawn 14 products for children under the age of 2. These included Dimetapp Decongestant Plus Cough Infant Drops and Robitussin Infant Cough DM Drops.