Drugmakers voluntarily withdraw infant cough medicines

The voluntary recall affects medicines made by Johnson and Johnson, which markets Tylenol, and Wyeth, which makes Dimetapp and Robitussin. The recall only affects medicines labeled for infants, not those intended for use in children age two years and older.

“It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately,” said Linda Suydam, president of the Consumer Healthcare Products Association (CHPA).

“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.”

The CHPA and its member companies recommended the FDA to strengthen the labels on all oral OTC children’s cough and cold medicines from ‘ask a doctor’ before using to ‘do not use’ in children under two years.

According to the FDA, which is planning to discuss the safety and effectiveness of cough and cold drug product use in children, some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used.