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FDA Should Ban Over-the-Counter Cough and Cold Medicines For All Children Under 12, Public Citizen Testifies

For Immediate Release:

Oct. 2, 2008 

FDA Should Ban Over-the-Counter Cough and Cold Medicines For All Children Under 12, Public Citizen Testifies

FDA Moving too Slowly to Stop Drug Industry From Pushing Ineffective Treatments

WASHINGTON, D.C. – The FDA should immediately ban all over-the-counter (OTC) cough and cold medicines for children under 12, Public Citizen told an FDA committee today.

The FDA is well aware that medical research proves that children younger than 12 taking OTC pediatric cough and cold medications fare no better than children who take no drugs at all. By taking drugs, in fact, the children are unnecessarily put at risk for adverse reactions, and their parents waste money on these ineffective treatments, said Dr. Alejandro Necochea, research associate at Public Citizen’s Health Research Group.

In addition, leading manufacturers of products like Pediacare, Robitussin and Triaminic have demonstrated that they cannot be trusted to self-regulate. In 2007, these manufacturers pledged to stop selling these medicines to children younger than two. Yet Public Citizen visited two area pharmacies last week and found that only 8 of 34 of the medicines on shelves warn parents not to give them to children under 2. Instead, nearly three quarters of these products ask parents to “consult [their] doctor” for infant dosages – a maneuver unlikely to be effective.

Testifying at today’s hearing, Necochea said, “In the absence of direct evidence that a product is effective, no amount of toxicity is acceptable.” Reports of serious adverse effects for this class of medications include convulsions, rapid heart rates, decreased levels of consciousness and death, Necochea said.

Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group, demanded that the FDA use its authority to protect patients. “By law, today’s meeting did not even have to take place.  The FDA is taking an unnecessarily slow path to ridding the market of these useless products,” Lurie said. 

Public Citizen is calling for the FDA to require manufacturers to remove devices like oral syringes intended for very young children from the market (in its survey, two products included such devices). Also, the manufacturers should add warnings indicating that children 12 and under should not take the drugs, and drug companies should remove images of children under 12 from labels and advertisements (the survey found images of young children on the boxes of three products). Public Citizen also called for the removal of combination OTC medications from the market, as they lead to unnecessary side effects and needlessly confuse parents, potentially leading to overdoses when two products contain the same active ingredient.

A copy of Drs. Necochea and Lurie’s testimony is available at: https://www.citizen.org/publications/release.cfm?ID=7599.