FDA Proposes New Limits on Pain Drugs

The Food and Drug Administration (FDA) is sending out conflicting signals when it comes to opioid pain medication. In one move, the agency recommended additional limitations on how a patient in chronic pain can access prescription painkillers.  On the same day the agency also approved a stronger version of a popular pain killer.

The FDA wants to reclassify hydrocodone, a powerful painkiller, in formulations where it is combined with other drugs such as acetaminophen. Vicodin (AbbVie Inc) and Lortab (Actavis PLC) are combination pills that are covered by a proposal to move them from a Schedule III to a Schedule II drugs not unlike oxycodone and morphine. Schedule II means the drug has a high potential for abuse and dependence.

The problem according to the Centers for Disease Control and Prevention (CDC) is that more than 16,500 people overdosed on opioid painkillers in 2010, topping all other classes  of drug-associated deaths, whether prescription or non-prescription.  Women tend to abuse painkiller drugs more than men with a 400 percent rise in overdoses in women since 1999, reports CBS.

About 130 million prescriptions were written for those painkillers in 2011 and the agency feels they are being abused. A 2009 recommendation by the Drug Enforcement Administration requested the change and in January an FDA advisory panel also recommended the medication be reclassified.

There are five classifications of drugs called “schedules” based on their use and potential for abuse. Schedule I drugs include heroin and LSD, while Robitussin is a Schedule V drug.

This image represents a 3D model of a hydrocodone molecule.

Under the proposal, doctors would not be allowed to write prescriptions for 180 days with five refills, the current standard, but would have to limit prescriptions to cover a 90 day period.  A patient would have to revisit the doctor to receive another prescription and only a doctor, not a nurse or physician’s assistant could prescribe. This is intended to avoid prescription abuse by some who sell prescription medication through doctor shopping.

The Wall Street Journal quotes the National Community Pharmacists Association as expressing concern that those truly suffering pain from cancer, nerve damage, MS or other ailments would be burdened by the rules, especially if they are unable to get out of bed.

Vicodin contains hydrocodone, the same drug that just received a green light for a stronger version.  On the same day as the proposed restrictions, the FDA approved a stronger version of the chronic pain drug, hydrocodone.

Called Zohydro, the painkiller is used to treat around the clock pain allowing a person to get some sleep. Last year, NBC reports, a panel of experts convened to review the medication and by a 11-2 vote disapproved approving it.

Hydrocodone is the most prescribed prescription medication for pain and the question posed by the panel was why we even need yet another similar drug.

The proposal to restrict the sale of opioids will be sent to the Department of Health and Human Services for a final decision, expected early next year.