March 02, 2007
FDA Reviewing Pediatric Cold Medicines
According to the Associated Press, the FDA has begun to review safety data for common OTC cold medications, especially when used in children under 2. High doses of these common medications have been linked to increased blood pressure and cardiac arrhythmia. A spokesperson for companies marketing these medications maintain that they are safe when taken in recommended doses, a point conceded by pediatricians. However, overdoses can result when a parent administers multiple medications to a child for the same symptoms. These medications have been on the market for some time, and the regulations under which they were approved have become more stringent.
The questions raised for pharmacy practice to consider in this situation are twofold. First, though it may be questionable ethically, there is a need for increased pediatric safety and efficacy data. While the FDA has been extending marketing exclusivity for firms who provide such data, the practice needs to become more widespread. Also, there is a need for vigilance at the community level. Community pharmacists must be on the watch for parents buying multiple medcations with the same active ingredients to treat both their children and themselves. With increased counseling of patients and further patient education initiatives, these situations can be avoided.
For more information, visit http://www.msnbc.msn.com/id/17417416/
Posted by kwiatkg at March 2, 2007 04:00 PM