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Generic Opioids May get Black Box Warnings

David Turnbull3 years ago

According to Pharmacy Times, some portions of the recent painkiller label changes required by the U.S. Food and Drug Administration will extend to generic drugs as well.

Opioid Painkiller Labels Change Requirement Extend to Generic Drugs

The Food and Drug Administration announced the label changes September 10, stating that generic manufacturers of extended-release or long-acting opiods will be required to revise labeling on products in order to include black box warnings stating risk of addiction and death as well as updated warnings on opioid use in pregnant women.  The warnings for pregnant women include fetal risks from misuse or abuse of the medication as well as Neonatal Opioid Withdrawal Syndrome (NOWS)

OxyContin®, Astramorph® and Vicoden® were all included in the list of brand name drugs for label changes; however, the FDA has expressed its intent to insure that labels are also updated for generic opioids including morphine and hydrocodone. Current litigation states that generic drug manufacturers cannot be held liable for label changes after the drug reaches market, and may only change labeling if ordered to by the FDA.

The FDA is also requiring opioid compounders to conduct additional research in order to curb painkiller abuse and deaths.

Dangers of Painkiller Abuse

  • The U.S. Centers for Disease Control and Prevention records about 14,800 prescription painkiller deaths every year – this is more deaths than those attributed to car accidents or gunshot wounds
  • Perhaps more alarming is that the rate of painkiller abuse has increased by 300 percent between 1999 and 2010. The rate of abuse is especially high among women, increasing 400 percent during the same time span.
  • When used during pregnancy, opioid painkillers can lead to birth defects including:

    • Spina Bifida
    • Hypocephaly
    • Conoventicular septal defect
    • Hypoplastic left heart syndrome
    • Atrial septal defect
    • Tetralogy of fallot
  • Nearly 1 in every 33 babies is born with a birth defect according to the CDC.  Birth defects are the leading cause of death in infants, and account for more than 20 percent of all 5,600 infant deaths each year.
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