FDA to Revise Regulations for OTC Children’s Cold Medicines
August 23, 2008
In response to growing safety concerns, the U.S. Food and Drug Administration (FDA) yesterday announced plans to revise standards for over-the-counter children’s cough and cold medicines. If the FDA finds that these products are ineffective and/or unsafe, over-the-counter children’s cold medicines could be permanently removed from the market.
Several nonprescription infant cough and cold medicines have already been recalled in response to an FDA health advisory issued earlier this year. Last January, after reviewing reports made to the agency and considering discussions made at a public advisory meeting in October 2007, the FDA issued a warning advising parents not to give over-the-counter cold medicines to children less than two years old. According to the FDA’s investigative findings, over-the-counter cold medicines do more harm than good, and may cause serious and potentially life-threatening side effects in children under two. Some evidence even suggests that young children receive no benefits at all from taking over-the-counter cold medicines.
A 2007 study conducted by the Centers for Disease Control found that, between 2004 and 2005, 1,500 children under the age of 2 were injured by common over-the-counter decongestants and antihistamines. Another study conducted by FDA safety reviewers reached similar conclusions, finding that, between 1969 and 2006, at least 54 children died after taking over-the-counter decongestants and 69 children died after taking over-the-counter antihistamines.
The FDA is still reviewing the safety of over-the-counter cold medicines in children between the ages of two and eleven. According to The Washington Post, the FDA will hold a special hearing on October 2 to consider a number of issues. One of the issues that will be discussed is the types of studies that should be done to evaluate the safety and effectiveness of children’s cold medicines. Additionally, the FDA will determine whether the drugs should remain available without a prescription. Dosage and ingredient combinations will also be discussed at the meeting.
Pending the completion of the FDA’s investigation, many doctors advise that parents should avoid using over-the-counter cold medications in children under 6 years old. In addition, the FDA has issued a Public Health Advisory listing several precautions that parents should take when giving cold medicine to children between two and eleven years old. (http://www.fda.gov/CDER/drug/advisory/cough_cold_2008.htm)
If your child has been harmed or has overdosed from taking children’s cold medicine, please contact our experienced defective drug lawyers today.