Drug companies say children under four years of age should not be given cough and cold medicines. The industry has been criticized by pediatricians for marketing over-the-counter cough and cold remedies for children under six despite a lack of evidence that they work, and reports of safety problems. The companies will also add a warning to their product labels saying parents should not give young children antihistamines to make them sleepy. Antihistamines are used to relieve allergies. While many parents believe that getting a sick child to sleep is the best medicine, the use of sedatives is widely discouraged by medical experts, who say they can worsen breathing problems caused by illness. According to government health officials, the issue needed additional study.
Officials at the Food and Drug Administration supported the changes, but promised to continue a long process to reassess the safety and effectiveness of the products in children of all ages. The government is hoping the new labels strike a balance between two competing concerns: that the drugs may not be safe in young children, but that some parents in turn may give their children adult medicines if the agency bans pediatric products.
Despite the products’ extraordinary popularity, every study performed in recent years shows that they have no therapeutic effect beyond sedation, and a growing number of reports have concluded that they can be dangerous. The risks are as varied as hives, neurological problems and, in rare cases, even death. Many injuries from pediatric cough and cold medicines occur when young children get their hands on medicine bottles without their parents’ knowledge. But accidental overdoses have also resulted when parents confuse dosing instructions or give their children two products without realizing that those drugs share ingredients.
The following is a statement by Dr. Peter Lurich, deputy director of health research at Public citizen:
Today, the leading manufacturers of over-the-counter cough and cold medications indicated that they are “voluntarily transitioning” toward putting a label on their pediatric products that instruct parents not to give the medications to children under four. This measure, announced by the Consumer Health Products Association (CHPA), clearly represents a political compromise, not a solution based on scientific evidence. It will do little to protect all children from these ineffective and, therefore, needlessly dangerous products. By announcing a four-year-old age restriction – halfway between the current voluntary limit oftwo2 years of age and the age limit of six requested in a petition submitted last year – the manufacturers are once again attempting to delay more definitive action by the Food and Drug Administration (FDA). The FDA must use its authority to make a strong, evidence-based decision not to allow these medications to be available to children under 12, rather than let the industry engage in this type of self-serving self-regulation.
A year after manufacturers of over-the-counter (OTC) cough and cold medications agreed to voluntarily withdraw their products for children under two from the market, a small Public Citizen survey found that less than a quarter of cough and cold medications on sale in two major pharmacies in Washington, D.C., and Baltimore, Md., carried labels warning parents not to use these medications in children two or younger. We have no confidence that today’s proposed “voluntary” measures by members of the CHPA (which does not represent all manufacturers of OTC cough and cold medicines, particularly generic ones) will be any more effective. Moreover, CHPA proposes to leave the medications on pharmacy shelves “throughout the 2008-2009 cough and cold season,” allowing the companies to reduce their inventories. By instructing parents not to give these medications to children under four, the new label sends the message that these medications are “safe and effective” for children four and over. This assertion is not true. Reviews by FDA Medical Officers and a more recent published study demonstrate that OTC cough and cold medications have not been proven to be effective in children under 12. In light of this ineffectiveness, any toxicity is unacceptable. The FDA needs to take a firmer stance to modify the regulations governing these products and must ensure that they are removed from the market unless new evidence proves them safe and effective. Unless the agency acts more expeditiously and forcefully, we will continue to see more unnecessary emergency room visits and deaths, and the annual squandering of hundreds of millions of dollars.
Source: Associated Press and Public Citizen
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