|
The Food and Drug Administration stated that it intends to revise standards for over-the-counter cough and cold medications for children. This could potentially result in removing some of the popular products from the market. In response to rising concerns that the products are ineffective and could be unsafe, the agency said it will revamp the criteria that have allowed the products to remain on drugstore shelves for the first time in decades. See http://www.ajc.com/health/content/health/stories/2008/08/25/children_cold_medicine.html The FDA is going to hold a special hearing Oct. 2 to begin to consider a series of questions, such as: What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available? The announcement is the latest response to a petition filed in March 2007 by a group of pediatricians requesting that the FDA limit the use of the products, citing that there is a lack of evidence that the medications are effective and increasing evidence they can cause hallucinations, seizures, trouble breathing, heart problems and other complications, including occasionally deaths. A week before the FDA convened a panel of experts to consider the petition in October 2007, drugmakers voluntarily pulled all over-the-counter cough and cold products for children younger than 2. After extensive review, the panel concluded that there was little evidence the medications worked for children younger than 12, advised that they not be used at all in those younger than 6, and called for investigation to establish their safety and effectiveness in children. In January, the FDA issued a public health advisory warning against using the products on children younger than 2, but the jury was still out on how the FDA would deal with the medications and older children. Friday's announcement was praised by critics, who predicted the process would eventually end in the medications being removed from the market. The industry, however, has vowed to keep the products on the market, saying they offer relief for older children as long as they are used according to directions.
|
