{"id":9233,"date":"2016-06-15T06:00:41","date_gmt":"2016-06-15T10:00:41","guid":{"rendered":"http:\/\/candostreet.com\/blog-parents\/?p=9233"},"modified":"2016-06-13T11:53:43","modified_gmt":"2016-06-13T15:53:43","slug":"labeling-for-kids-medications","status":"publish","type":"post","link":"https:\/\/candostreetny.com\/blog-parents\/labeling-for-kids-medications\/","title":{"rendered":"Labeling for Pediatric Medications"},"content":{"rendered":"

\"pediatric\"<\/a>The Food and Drug Administration (FDA) has made it easier for parents and health care professionals to find information on pediatric medications. The FDA created a database that covers medical products studied in children under recent pediatric legislation.<\/strong><\/em><\/span><\/h1>\n

The C<\/sup><\/a>4<\/sup> is a one-stop resource. You can search for information by the product\u2019s commercial or chemical name, or by the condition for which it was studied. FDA’s Office of Pediatric Therapeutics (OPT), which focuses on safety, scientific, and ethical issues that arise in pediatric clinical trials or after products are approved for use in children, developed the tool in collaboration with another branch of the agency, the Center for Drug Evaluation and Research.<\/p>\n

OPT also maintains a Safety Reporting page<\/a>5<\/sup> with information on products that have been tied to safety problems that specifically relate to children. This page lists products that have been the subject of an adverse event report presented to FDA\u2019s Pediatric Advisory Committee, a group of outside experts that advises the agency on pediatric treatments, research and labeling. (An adverse event is any undesirable experience associated with a medical product.)\u00a0 The committee\u2019s recommendation is also given if further actions were necessary to ensure safe use of the product in children.<\/p>\n

\u201cWe are excited to share this goldmine of information with parents,\u201d says Debbie Avant, R.Ph., the health communications specialist in OPT who helped develop and maintain the database. \u201cWe want parents to know they can rely on FDA for accurate, timely information about the medications their children take.\u201d<\/p>\n

Pediatric Medication Labels<\/strong><\/em><\/span><\/h2>\n

Parents should always read medicine labeling carefully. For prescription medications and vaccines, there is a Pediatric Use section in the labeling that says if the medication has been studied for its effects on children. The labeling will also tell you what ages have been studied. (This labeling is the package insert with details about a prescription medication.)<\/p>\n

Congress\u2019 efforts to increase the number of studies of prescription drugs used in children have allowed FDA to build a foundation for pediatric research and discover new things. For example, researchers have found that certain drugs produce more side effects for the nervous system in children than adults, says Dianne Murphy, M.D., OPT\u2019s director.<\/p>\n

FDA is able to use information gathered from pediatric studies to make labeling changes specific to kids, and to share that news with the public. The database, which is updated regularly, currently contains more than 440 entries of pediatric information from the studies submitted in response to pediatric legislative initiatives. The labeling changes include:<\/p>\n