FDA Approves Opiate Painkillers For Children
Yesterday, the Food and Drug Administration approved a powerful and addictive painkiller OxyContin for use in children ages 11 to 16 enduring sever and long-term pain. Purdue Pharmaceuticals notes that it reformulated its OxyContin in 2010 to hedge problems with addiction, overdose and death. Slower release was also a part of the reformulation.
Sudden doses of opioids can cause overdose and death especially without previous exposure. Deaths from painkillers have been a controversial topic in recent years. So much so that states that have legalized medical cannabis have seen a 25% drop in painkiller death rates.
OxyContin is an extended-release opioid that has long been used to treat around-the-clock pain in adults. But most pain medications are not approved for use in children.
The FDA says it asked drugmaker Purdue Pharma to study how to safely use OxyContin in children.
“This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients,” Sharon Hertz, an FDA drug division director, wrote in an online post.
Under the new approval, doctors are directed to only prescribe OxyContin to children who can already tolerate a minimum dose of 20 milligrams of oxycodone, the drug ingredient in OxyContin.
An final study on injury, overdose, accidents and medication errors in patients ages 11 to 17 is due April 2019. The FDA views physical trauma, post-surgical and cancer as appropriate uses for children and teens.
One wonders why it took so many problems (and death) before the company reformulated – is it because they can fall back on safety approval from the FDA? Does this not further highlight the need for safer options of pain relief in children?
This summer, “the Oxycontin Clan” made it Forbes’ list of the richest U.S. families. The Slackler family, who owns the Purdue Pharma empire is worth $14 billion dollars, surpassing the wealth of some Bushes, Mellons and Rockefellers.
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