Baltimore Health Commissioner Tells FDA Panel That Cold Medicines Are Dangerous for Children Under Age Six

Dr. Joshua M. Sharfstein, a pediatrician and the Baltimore Health Commissioner told a Food and Drug Administration (FDA) advisory panel that cough and cold medicines don’t work and are dangerous for children under six years of age. He attributed lax FDA regulations as the reason that pharmaceutical companies are allowed to market drugs to the parents of young children—even though there is no proof that the drugs are effective and there is growing evidence of related illnesses and deaths.

Sharfstein is part of a group of pediatricians trying to convince the FDA to stop drug manufacturers from marketing cough and cold medicines to the parents of young children.

Last week, drug manufacturers voluntarily pulled cold and cough medicines by Tylenol, Little Colds, Triaminic, Pediacare, and Robitussin for infants, toddlers, and young children. Manufacturers cited concerns that parents might give too big a dose to their children who are younger than six years of age. Labels provided on the medicines withdrawn suggest that parents ask a doctor for advice regarding dosage.

The CDC says that since 2005, some 1500 toddlers and infants have been taken to hospital emergency rooms because of an adverse reaction to taking cold medication.

The FDA says that there have been 54 reported infant fatalities attributed to decongestants. Antihistamines reportedly caused 69 child deaths.

Two months ago, federal health officials recommended that the “ask the doctor” directive be replaced with a warning not to give the medication to children younger than 2 unless specifically instructed on how to do so by a pediatrician.

If you suspect that your child may have gotten sick or died because of a dangerous drug or because a drug manufacturer did not provide the correct instructions on the dosage to give your child, you should speak to an experienced products liability attorney in Maryland or Washington D.C.

The drug manufacturer is legally obligated to reasonably protect all consumers and must include safety warnings of any potential side effects. A drug manufacturer can also be held liable for personal injury if it markets the drug in a way that misrepresents it.

Sharfstein makes case to ban cold remedies, Baltimore Sun, October 18, 2007
Child deaths lead to FDA hearing on cough, cold meds, CNN, October 17, 2007

Related Web Resources:

What Parents and Caregivers Need to Know: OTC Cough and Cold Medicines and Children, Consumer Healthcare Products Association
Drug Facts Label

To schedule your free consultation with one of our experienced products liability lawyers, contact Lebowitz & Mzhen today.

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