FDA Considers Limiting Access to Painkillers
Written by Faith Anderson on July 27, 2012
Doctors Over-Prescribing Painkillers
The petition issued to the FDA calls for a label change to eliminate the word “moderate,” and to institute a maximum dose equivalent to 100 mg a day of morphine and a time period of no more than 90 days when treating non-cancer pain. Use beyond these terms would be considered “off-label,” preventing drug companies from promoting the drugs for these uses. In addition to marketing by drug companies, the petition also identifies doctors who are over-prescribing painkillers and writing prescriptions for high dosages as the reason for the label restriction. “By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids,” the petition states.
Prescription Drug Abuse on the Rise
In January, Controlled Substance Workgroup, a subdivision of the Wisconsin State Council on Alcohol and Other Drug Abuse, identified narcotic and prescription drug abuse as a growing problem in the state. “Ten years ago we had more illegal drug use and now we have more legal drug abuse because it seems to be more in vogue,” said Larsen. But Larsen worries that if prescription painkillers are more difficult to come by, abusers will switch back to illegal drugs and people who are legally prescribed the drugs will be targeted for burglaries and theft.
Opioid Overdose Deaths and Painkiller Addiction
Before the late 1990s, opioid painkillers had been used primarily to treat short-term pain, such as pain related to surgery, as well as pain associated with cancer and end-of-life diseases. Since then, numerous companies that market opioids have begun to promote the medications for long-term, non-cancer pain like low-back pain and fibromyalgia. As a result, prescriptions for opioids have increased four-fold in the past decade, leading to significant increases in opioid-related overdose deaths and people seeking treatment for painkiller addiction. In light of the prevalence of prescription drug abuse in the U.S., states like Wisconsin have taken a tougher stance against offenses like driving under the influence of painkillers and other prescription medications, and many say the next step is for the FDA to take action on the petition. According to FDA spokesperson Morgan Liscinski, officials with the agency will review the petition and give their response directly to Public Citizen.