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From Health Law Daily, March 24, 2016

Immediate-release opioids get new boxed warning, all Rx opioids get labeling changes

By Harold Bishop, J.D.

In response to the opioid epidemic and in an effort to further educate patients and prescribers, the FDA announced class-wide safety labeling changes for immediate-release (IR) opioid analgesics, including a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. The FDA also announced several additional safety labeling changes across all prescription opioid products.

Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone, and morphine. Other opioids, such as methadone and buprenorphine, are used in combination with behavioral therapy and counseling to treat opioid addiction. This treatment is known as medication-assisted treatment (MAT). Prescription opioids are divided into IR products, intended for use every four to six hours, and extended-release/long-acting (ER/LA) products, primarily intended to be taken once or twice a day.

Prior action on ER/LA opioids. On September 10, 2013, the FDA announced class-wide labeling changes for ER/LA opioid analgesics that included modifications to the products’ indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the serious risks associated with these drugs. The FDA is now requiring similar changes to the labeling of IR opioid analgesics.

Indication updated. The FDA’s updated indication for IR opioid products clarifies that they should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.

New boxed warning. The new boxed warning requires a precaution that chronic maternal use of IR opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts.

Updated labeling of all opioids. The labeling requirements of all opioids (ER/LA and IR) are also being updated, as outlined in a FDA Drug Safety Communication to: (1) include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome: (2) include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) and decreased sex hormone levels (androgen deficiency); and (3) make it clear that negative outcomes can occur whether a patient is taking an opioid to treat pain or if the product is being used for MAT.

Benzodiazepine interactions. The FDA is also reviewing scientific information related to interactions between benzodiazepines (i.e., tranquilizers such as Valium® and Xanax®) and opioids. Once a review of all available scientific information is completed, the FDA plans to take steps to ensure prescribers and patients are informed of the risks involved with the use of these medications.

Opioid antidote (naloxone). On March 26, 2015, the FDA announced an evidence-based HHS opioid initiative focusing on three informing opioid prescribing practices, increasing the use of naloxone (an opioid overdose antidote), and expanding access to and the use of MAT.

House hearing. On March 22, 2016, the House Committee on Oversight and Government Reform held a hearing to highlight the alarming increase in abuse of illegal opioids, such as heroin and fentanyl, as well as controlled prescription opioids such as hydrocodone and oxycodone.

At the hearing, Rep. Elijah Cummings (D-Md) addressed the issue of price gouging by Amphastar Pharmaceuticals Inc., the manufacturer of naloxone. . Cummings accused Amphastar of raising prices for the antidote as demand has increased. Cummings said, “As more first responders began using this drug, the company that makes it, Amphastar, began to increase its prices by staggering amounts. In May 2014, a 10-dose pack cost the Baltimore City Health Department roughly $190. Guess what? Today, it costs more than $400 for a life-saving drug.”

According to the witnesses at House hearing, the following facts are clear:

  • Drug overdoses are the leading cause of accidental death in the United States.
  • Experts believe the current epidemic of opioid abuse has contributed to an increase in heroin deaths as opioid consumers move towards heroin use.
  • In recent years, opioid-related overdoses have begun to decrease while heroin-related overdoses have sharply increased.
  • According to the Drug Enforcement Administration, Mexican-based criminal organizations are the principal suppliers of heroin in the United States.
  • Primary and secondary prevention programs are in place to decrease the use of potential gateway drugs in youth and others vulnerable to heroin use.
  • In 2015, $400 million was appropriated to address the opioid epidemic, an increase of $100 million. To date, none of the money has been spent.

In their comments, the House committee members emphasized the need to stop the flow of heroin across the southern border. Subcommittee Chairman John Mica (R-Fla) stating, “Treatment is at the end of the process — they’ve already been addicted. We have got to stop this stuff at our borders.”

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