You know that some prescription drugs come with serious potential risks. That includes prescription painkillers known as opioids (oxycodone, for example). This week, the Food and Drug Administration (FDA) announced new requirements regarding all extended-release and long-acting (ER/LA) opioid analgesics.
Ã¢â‚¬Å“Opioids are powerful medications that can help manage pain when prescribed for the right conditions and when used properly,Ã¢â‚¬Â said FDA Commissioner Margaret Hamburg, M.D., in a phone press conference on Tuesday. Ã¢â‚¬Å“However FDA is extremely concerned about the inappropriate use of opioids which has reached epidemic proportions in the United States and has become a major public health challenge.Ã¢â‚¬Â
Opioids had a hand in 16,651 overdose deaths in 2010, according to the Centers for Disease Control and Prevention (CDC). And for women specifically, deaths from opioids rose fivefold between 1999 and 2010, according to a CDC analysis.
Majorly scary stuff. Those numbers cover all opioidsÃ¢â‚¬”the new FDA guidelines, however, only apply to the forms that are extended-release and long-acting. TheyÃ¢â‚¬â„¢re especially concerning, according to the FDA.
WhatÃ¢â‚¬â„¢s New? Right now, the labeling on ER/LA opioids says theyÃ¢â‚¬â„¢re for Ã¢â‚¬Å“the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.Ã¢â‚¬Â Under the new guidelines, that will change to say that theyÃ¢â‚¬â„¢re Ã¢â‚¬Å“indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Ã¢â‚¬Â The new labeling will explain that these drugs are only meant for people who canÃ¢â‚¬â„¢t use other treatments because they can lead to addiction, abuse, and misuse, even when people take recommended dosesÃ¢â‚¬”as well as overdosing or death.
Another requirement: ER/LA opioids will need to include a boxed warning that they can cause neonatal opioid withdrawal syndrome (NOWS)Ã¢â‚¬”which can be life-threateningÃ¢â‚¬”in babies who are exposed to them in utero.
The FDA is also instructing the companies that make these drugs to get to work on new research to determine more about the long-term effects of ER/LA opioids.
For more information about ER/LA opioids and the new guidelines, click here.
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