On September 26, the committees will discuss the required pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by law. The committees will also discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Opana (oxymorphone) immediate-release as an example. While the agency continues to take steps to actively confront the abuse and misuse of opioids, careful attention must also be paid to the needs of patients and physicians in managing pain, particularly as it pertains to pediatric patients. Opioid analgesics serve an important medical purpose in the care of certain pediatric patients when a physician deems them appropriate, including in pediatric patients with cancer and sickle cell disease or, more commonly, those who have suffered traumas, burns or have surgery to correct birth defects. In 2015, the FDA approved an expanded indication for OxyContin to include the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in opioid-tolerant pediatric patients 11 years of age and older who already receive and tolerate a minimum daily opioid analgesic dose of at least 20 mg oxycodone orally or its equivalent. Although there have been no new safety issues identified for OxyContin among pediatric patients since then, in the interest of transparency, the agency will present the legislatively mandated review of the safety information to the committees in a public forum.
On the second day, the committees will hear information about safety signals associated with montelukast, a medicine that has been approved for use in the United States since 1998 and is prescribed to over two million pediatric patients (infants to 16 years of age) each year for asthma or allergic rhinitis. In 2009, the label for montelukast and other leukotriene modifiers (zafirlukast and zileuton) was updated to include a warning for neuropsychiatric events, including agitation, anxiety, depression, sleep abnormalities, and suicidal thinking and suicide. Two years ago, in response to public feedback, the FDA commissioned a study in children to explore the adverse effects associated with montelukast. The focus of the study was on neuropsychiatric events including serious depression, self-harm and suicide. The committees will discuss the results of that recently completed Sentinel study. The FDA is committed to working with health care professionals and the public to educate them about the importance of discussing the side effects of montelukast, so patients and their families can make informed decisions and look for warning signs while taking the drug.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
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