According to the Consumer Healthcare Products Association, many makers of cold medicines for infants are voluntarily recalling their products. The recall was initiated for safety purposes. After reviewing the side-effects of these drugs on infants the FDA found that there have been many fatalities due to the drugs.
“The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority,” states the association’s president Linda A. Suydam.
She also stated that if the drugs are used as directed than they are safe and effective, but some parents have not been following the directions on the labels precisely.
Last month, federal health officials recommended that the “consult your physician” advice to parents on the labels of cold and cough medicines aimed at young children be dropped and a warning not to use the medications in children under 2 be added. The U.S. Food and Drug Administration will officially consider revising the labels at a meeting next week.
The FDA’s review on infant medications revealed that there have been 54 child fatalities from over-the-counter decongestant medicines and 69 reports of children’s deaths connected with antihistamines over the past four decades. The withdrawal does not affect medicines intended for children ages 2 and older.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.