FDA Proposes New Painkiller Restrictions

New restrictions on the prescribed painkiller market have been proposed in an effort to combat opioid abuse and overdose rates in the United States.

In an announcement on Tuesday, the Food and Drug Administration (FDA) introduced the new market restrictions, which would primarily target "potent painkillers" that involve the combination of hydrocodone with other painkilling drugs such as acetaminophen.

According to the FDA, these painkillers are currently labeled as Schedule III drugs, meaning patients can submit a prescription orally over the phone to order the drugs. The new restrictions would re-label the combination painkillers as Schedule II drugs, requiring patients to hand deliver or fax prescriptions filled out by their doctor in order to get access to the painkillers. A Schedule II label would also eliminate the ability for regular refills, now requiring a physician to re-issue a new prescription for every refill.

The FDA says this change in regulation would help prevent abuse of the combination painkillers, which currently are contributing to the opioid overdose epidemic the U.S. is facing. These combination drugs have been known to be particularly dangerous to drug abusers because overdosing from them can result in two fatal reactions. Traditional opioid overdoses associated with hydrocodone and heroin result in a spiked heart rate and asphyxiation, but secondary effects resulting from overdose of the combination drug, such as acetaminophen can make things even worse. Acetaminophen overdoses, for instance, are known to lead to severe and often fatal liver damage.

According to the Centers for Disease Control and Prevention, deaths tied to prescription opioid deaths have more than quadrupled since 1999 with over 16,000 deaths in 2010.

While these proposed regulations appeals to the demands of anti-opioid abuse groups such as Physicians for Responsible Opioid Prescribing, the FDA is simultaneously enraging them with the approval of a new hydrocodone (non-combination) painkiller that is designed to treat chronic pain.

The new painkiller, Zohydro, contains approximately ten times more hydrocodone than most opioid painkiller currently in the U.S. market, making it a new likely cause of overdose in abusers.

Thankfully, the new pill is already classified as a Schedule II drug, at least hampering how easily drug abusers can get their hands on it.

The proposed restrictions for combination hydrocodone painkillers are scheduled to be submitted to the Department of Health and Human serviced by early December. The U.S. Drug Enforcement Agency will have the final say concerning the regulation changes.