Senator Charles Schumer Responds to New Painkiller Labeling Requirements
Opioid Prescription Labels
- At one point, a little more than a decade ago, opiates like OxyContin were actually considered to carry little risk with them. The ten years that followed, however, would paint a very different picture.
- Data clearly shows that fatalities associated with opioids were greater than those related to heroin and cocaine use combined from 1999 to 2010.
- One factor in this troubling statistic was that original labels for these drugs, approved by the Food and Drug Administration, actually carried the claim that addiction was unlikely.
- This resulted in many doctors prescribing the pill with less concern. The result of that was more people taking the pills, becoming addicted and dying from overdoses.
Senator Schumer and the FDA
“The FDA’s new labeling requirements will clearly and prominently warn women of the dangers of chronic opiate use during pregnancy – it will be a crucial treatment in the battle against infant opiate addiction and withdrawal syndromes, and I’m pleased that the FDA heeded my call.” – Senator Charles Schumer
- Senator Charles Schumer recently claimed a victory when he said the Food and Drug Administration had taken his advice to heart and agreed to add warnings on the labels of opioids that addressed the threat they posed to pregnant women and their unborn children (i.e. being born with an addiction they received from their mother).
- It has also been shown that opioid use during pregnancy may increase the risk of birth defects three fold.
- Specifically, the changes being made will include new warnings on neonatal opioid withdrawal syndrome, as well as a new aftermarket study directives for all opioids (extended release and long acting) made for the purpose of treating pain.
- The FDA will also be mandating new studies be done by the companies who make these drugs.
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