Upcoming Changes to Acetaminophen‐Containing Opioid Products
In January 2011, the FDA announced that drug manufacturers will be required to limit the strength of acetaminophen (APAP) contained in prescription drug products to 325 mg per tablet, capsule, or other dosage unit. The FDA believes that limiting the amount of acetaminophen per dosage unit may reduce the risk of severe liver injury from overdosing, and thus limit subsequent cases of liver failure, liver transplant and death.
The move will have little legal impact in New York, where Attorney General Eric Schneiderman pushed through a reclassification in 2013 as part of a campaign to curb drug abuse…
It’s still too soon to know whether New York can provide a useful test case for the federal change. There isn’t enough data to know whether opioid addictions have been impacted or whether prescribing habits have changed, but New Yorkers have no trouble getting oxycodone despite its more restrictive classification.
Bridget Brennan, the city’s Special Narcotics Prosecutor told the city council in 2012 that hydrocodone prescriptions had fallen 4 percent in 2011, but “could be explained by a shift to oxycodone.”
Her office reported that the number of oxycodone prescriptions filled by New York City residents increased 124 percent between 2007 and 2011.
In 2013, the mayor’s taskforce on prescription painkiller abuse reported that the number of oxycodone prescriptions filled in 2012 increased 83 percent from 2008 to 2012, while the number of hydrocodone prescriptions has decreased by 15 percent.