Petition Calls on FDA to Ban High Dose Opioids

By Pat Anson, Editor

A group of anti-opioid activists has filed a citizen petition with the Food and Drug Administration, asking the agency to remove most high dose opioid pain medications from the market.

The petition would apply to all opioid pills that exceed a daily dose of 90mg morphine equivalent units (MMEs), which the Centers for Disease Control and Prevention set last year as the highest recommended dose for primary care physicians and their patients.  

Such a ceiling, if adopted by the FDA, would take all OxyContin 80mg tablets off the market, as well as many other high-dose oral painkillers. A single OxyContin 80mg tablet, according to the petition, is equivalent to 160 MME.

Another example cited in the petition would be immediate release oxycodone 30mg tablets. If four such pills are taken daily, as they are often prescribed, that adds up to 180 MME.

The petition claims high dose opioid pills raise the risk of overdose and addiction, and are especially harmful to children.

“These products are just too dangerous, there's no need for them," said Pete Jackson, who lost his teenage daughter to an OxyContin overdose.

"These are not medicines. These are lethal weapons that should be removed from the market," said Andrew Kolodny, MD, an addiction treatment specialist and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), one of five anti-opioid activists who signed the petition. None are considered experts in pain management.

“Removing UHDU (ultra-high dosage unit) orally-administered opioids from the market will result in patients having to swallow more tablets or capsules. But this is unlikely to result in a significant inconvenience or hardship for patients,” the petition states. “For patients that may have difficulty swallowing it is important to note that opioid analgesics are available in liquid preparations, sublingual preparations, patches and suppositories.”

Opioids ‘Can Be Appropriate’

In a rare acknowledgement that opioids "can be appropriate" for some pain patients, Kolodny and the other petitioners wrote that "the benefits of prescribing high doses may outweigh the risks when treating severe pain from a life-limiting illness."

But then they make the dubious claim that flooding the market with lower-dose pills will somehow be safer. Reducing the potency of painkillers would mean patients need more to get pain relief – resulting in more pills being prescribed, stored in medicine cabinets, and possibly stolen or diverted – hardly a prescription for reducing abuse.

Having to take more pills could also be risky to patients.  

"With a very large number of pills to manage, they are going to be at more risk of taking the wrong number of pills and of having some of those pills swiped by others without them noticing," Stefan Kertesz, MD, an Alabama primary care physician, told the Associated Press.

“Given the significance of the nation’s opioid crisis, this petition and issue should be discussed by the scientific experts at FDA and we look forward to participating in such a discussion,” Purdue Pharma, the maker of OxyContin, said in a statement. “It is critical that we seek the appropriate balance of treating pain severe enough that requires opioid treatment for which alternative treatments are inadequate, with efforts combating the opioid crisis.”

The FDA had no immediate comment on the petition.  Any U.S. citizen can file a petition with the agency to seek the removal of a drug or medical device for safety issues.

In June, the FDA asked Endo Pharmaceuticals to take Opana ER off the market because it was being abused, the first time that sales of an opioid painkiller have been halted. FDA commissioner Scott Gottlieb, MD, has hinted the agency could take other painkillers off the market.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said in June.

To make a comment on the PROP petition to the FDA, click here.