PHARMACY NEWS: FDA REQUIRING BOXED WARNING ON IMMEDIATE RELEASE OPIOIDS
On March 22nd, the FDA updated the labeling requirements for immediate release opioids. Prescriptions such as hydrocodone, oxycodone, and morphine will require the black boxed warning stating that these medications can lead to addiction, misuse, overdose and death. The warnings will also include risks for pregnant women stating that use while pregnant can result in opioid withdrawal syndrome in newborns.
The FDA sent letters to drug companies informing them of their obligations on March 22nd and expects to be finished reviewing the company-submitted materials by the end of the year.
In 2013, the FDA required class wide labeling changes for the ER/LA opioid analgesics; this most current announcement, however, will include the labeling of many more products - 87 innovator products and 141 generics.