We have an epidemic in America. We have all seen it on the news. We may even know someone who has...READ MORE
FDA Issues Black-Box Warning for Opioids
The U.S. Food and Drug Administration issued an announcement on March 22, 2016 stating that manufacturers of immediate-release opioids are now required to add what is referred to as “black-box warnings” to their labeling in order to inform users of potentially severe complications. These include risks of addiction, abuse, overdose and death.
As Serious as it Gets
The purpose of the warning, according to the announcement, is to fight what the agency describes as “an epidemic of addiction.” That may sound like hyperbole, but it’s anything but. The Centers for Disease Control reported that nearly 17,000 people died of prescription painkiller drug overdoses in 2014.
A black-box warning is the strongest issued warning by the FDA. It is only issued when there is substantial evidence of serious hazards associated with a drug. The agency is now requiring that medications such as oxycodone (marketed under the brand name OxyContin) and hydrocodone carry labeling stating they should only be used in cases of severe pain where no other treatments have proven effective. Also, the FDA now requires that dosage instructions clearly state not only how much of a drug should initially be taken, but also how that dosage should be adjusted.
But addiction and overdoses are not the only complications associated with opioid use. Labels will also need to carry information regarding the risk for the following:
- Adrenal insufficiency – A disorder that affects blood pressure as well as the metabolism of carbohydrates, fats and proteins.
- Androgen deficiency – Opioids can inhibit the production of androgen, which is vital to proper sexual functioning.
- Serotonin syndrome – Opioids have also been linked to excessive production of serotonin, which can lead to a wide range of symptoms. Mild issues such as diarrhea have been reported, but so have seizures and fever. If this problem is not treated, it can even be fatal in some instances.