Scrutiny and Praise for the FDA on Painkillers

Last week was a big news week for the FDA who has gained both scrutiny and praise for its decisions regarding prescription painkillers.

The FDA finally recommended that hydrocodone containing drugs are reclassified from a Schedule III drug to a Schedule II drug, which imposes greater restrictions on prescribing and access to this class of drugs. By changing the classification they will be restricted in the same way oxycodone and morphine are.

Given that hydrocodone drugs are the most widely prescribed in the US and the highly addictive, this has been long awaited. In 2011 alone, there were 131 million prescriptions written for hydrocodone and according to the DEA it ranks as the first or second most-abused medicine in the U.S. alongside oxycodone. The abuse of these drugs has resulted in an estimated 100,000 accidental overdoses in the US over the last decade. A huge proponent of this measure, Democratic Sen. Joe Manchin stated this was a “tremendous step forward in fighting the prescription drug abuse epidemic that has ravaged West Virginia and our country,” and “Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities.”

Just as the praise was soaring for the FDA, they announced their approval of a new painkiller that is a stronger version of hydrocodone called Zohydro ER. The drug is stronger for those that require around the clock pain management that requires pure hydrocodone rather than the current versions that combine hydrocodone with non-narcotics like acetaminophen. The approval reportedly came as surprise since a panel of pain specialists gave it a negative review last year – saying the US didn’t need another form of widely abused prescription drugs.

Patient safety advocates like Avi Israel, who lost her son who committed suicide while struggling with painkiller addiction, asserted, “We’re just going to kill more kids and then the FDA is going to come back and say, ‘oh, we made a mistake.’” Lawmakers in Washington who have been working hard to deter prescription abuse in their states were especially critical of the fact that the pills have no abuse deterrents (so they can’t be crushed or snorted) like the new forms of OxyContin do; “FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features. This is outrageous,” said Rep. Bill Keating, D-Mass.

Here at Harmony Foundation we continue to see the trend of opioid painkiller abuse in our prescription drug treatment program in Colorado – among young adults and adults alike. While the new reclassification measure is notable, we share the sentiment of Keating and Israel that there does not need to be yet another prescription drug with potential for abuse on the market.