Recall of Infant Cough and Cold Medicines
Update: FDA committee decides that children under 6 should not be administered OTC cold medication.
Boy, oh boy, there has been a lot of confusion in the press about the safety of over-the-counter (OTC) cough and cold medicines for children. And, more news is expected as the FDA meets next week (Oct 18 & 19, 2007) to discuss this issue.
Below is a timeline of news and events, which culminated today in a voluntary recall of many Infant Cough and Cold Medicines.
Today’s news (October 2007):
Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines:
* Potential misuse of these infant medicines, not product safety, is driving the voluntary withdrawal
* This withdrawal does not affect cough and cold medicines for children age 2 and older
* Further evaluation of these oral cough and cold medicines for infants and children will occur at the October 18 and 19 FDA advisory committee meeting
Snapshot of the recalled products:
Timeline:
January 12, 2007: CDC issues a report highlighting three deaths of U.S. infants aged less than 12 months associated with cough and cold medications.
August 16, 2007: FDA announced that in October 2007, an FDA advisory committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age.
October 2007: FDA urges parents to be careful when giving cough and cold medications to children, especially those younger than two. Serious and even fatal adverse events can occur if a child is given too much medicine, or it is given too often, or if the child is given more than one medicine that contains the same active ingredient.
October 2, 2007: Consumer Healthcare Products Association (CHPA) tries to clarify innacurate and misleading media reports surrounding the FDA’s position on cold and cough medicines (in light of its upcoming FDA advisory committee meeting), which may have caused unnecessary alarm and confusion amongst parents. “FDA has not called for a ban on medicines for children under 6. Rather, the agency has presented a variety of internal and external recommendations for discussion at the upcoming advisory committee meeting.
October 11, 2007: makers of OTC cough and cold medicines announce voluntary withdrawal of oral infant medicines (for children under 2 years old). See above.
October 18-19, 2007: FDA advisory committee meeting.
Bottom-line:
The FDA has made some common-sense recommendations that all parents should follow.
Here are some recommendations for parents from the FDA:
• Do not give children medicine that’s made for adults. Only use products marked for babies, infants or children, which are sometimes labeled as “pediatric”. Caregivers should be sure to read the “Drug Facts” box on the label to understand how to use the product and know the active ingredients and warnings.
• Do not give your child other prescription or non-prescription medicines at the same time as cough and cold medicines without first checking with your child’s healthcare provider.
• Do not use kitchen utensils like a teaspoon or tablespoon to measure out liquid medicines. Instead, use the dropper, dosing cup or dosing spoon that comes with the medicine. If a measuring device is not included, buy one at a pharmacy and be sure it has markings that match the dosing recommendations on the drug label or given by your child’s healthcare provider.
• Await findings from the FDA’s October 18 & 19 meetings discussing the safety and effectiveness of cough and cold products for children.
