The FDA's approval of OxyContin for children as young as 11 has sparked controversy with some critics calling this decision "irresponsible," according to The Washington Post.
Here are seven key thoughts:
1. While some pediatricians and pain specialists applauded the FDA's decision, critics claimed children could become addicted to the drug.
2. The opposition called for a Senate investigation into the decision. Sen. Joe Manchin III (D-W.Va.) stated OxyContin will "poison our children's brains and set them up for future drug abuse."
3. The FDA argued its approval was intended to provide physicians with better guidelines about how to use OxyContin safely in pediatric patients. Many physicians prescribe OxyContin and other painkillers "off-label" to children with cancer, major surgeries or other trauma.
4. Purdue conducted studies investigating the safety and effectiveness of OxyContin in pediatric patients. The findings supported the use of the drug in limited situations including cases where pain cannot be treated effectively with less potent painkillers.
5. Critics claim the FDA did not sufficiently analyze the risk of addiction in young brains and the new approval will result in Purdue marketing OxyContin more broadly.
6. In 2007, Purdue pleaded guilty to falsely marketing OxyContin by downplaying the drug's risk of addiction and potential for abuse. The company paid approximately $635 million to resolve misbranding charges.
7. Despite addiction risks, many providers and parents believe OxyContin is necessary to alleviate pain children with serious health conditions experience daily.
More articles on pain management:
8 pain physicians on the move - Sept. 9, 2015
10 things to know about prescription opioid abuse in the United States
42 hospitals join collaborative to reduce opioid use — 7 notes