FDA Panel Forbids Use of Cold Medicines in Children

Voting 13-9 against the use of cold medications in children between the ages 2 and 6, the advisory panel at the U.S. Food and Drug Administration today negated the safety and efficacy of the over-the-counter cough and cold remedies. The panel conceded that the cough and cold medicines do no good and may be risky for children if not properly used.

Commonly used by parents to relive their children from cough and cold, the over-the-counter nonprescription cold medications were accused for their safety and effectiveness with no evidence that the medicines do any good for the children. Moreover, there were mounting concerns about the sedative ingredients of the drugs.

The matter came to light when the use of such medicines caused deaths in a number of children mostly under the age of 2 years, mainly due to overdosing. The panel voted 21-1 for the ban of such drugs in children under 2 years.

Arguing for the ban on such drugs, FDA advisory panel member Amy J. Celento-Stamateris said, "Parents are using these medications to relieve what they consider symptoms, which in reality means their child is sedated and they are able to sleep."

While the committee's recommendations apply to all medications containing either or all of the following ingredients: decongestants, antihistamines and antitussives, it doesn’t apply to expectorants – a common ingredient of many over-the-counter remedies.

However, the manufacturing companies maintain that the drugs are completely safe and effective when used properly. "We're going to be working with the FDA, and we believe these products will stay on the market," said Linda Suydam, president of the Consumer Healthcare Products Association. The over-the-counter drugs make up to $500-million-dollars-a-year for the drug manufactures.

While safety remains the key ingredient, the manufactures support the call of adding ‘warning labels’ along with ‘suitable dosage as-per-age’ on the medicine bottles. They also maintain to take up additional studies to study drug’s effectiveness.

In general "keeping a child well-hydrated, using a humidification device in the room, employing salt water nose drops, and using acetaminophen or ibuprofen for fever or discomfort is more than enough symptomatic care. Left to its own devices, the body tends to mend itself admirably," Dan Leby, President of American Academy of Pediatrics suggested parents.