July 24, 2016

Partly cloudy

FDA approves ‘rescue pen’ for opiate overdoses

WASHINGTON — Friends and family will be able to take the first step to save a loved one from an overdose of heroin or powerful painkillers called opioids.

The Food and Drug Administration on Thursday approved an easy-to-use device that automatically injects the right dose of an overdose antidote named naloxone before an ambulance arrives. Doctors could prescribe it for family members or caregivers to keep on hand, in a pocket or a medicine cabinet.

Opioids include legal prescription painkillers, such as OxyContin and Vicodin, as well as illegal street drugs like heroin.

Called Evzio, the device contains naloxone, a long-used antidote for overdoses that is usually administered by syringe in ambulances or emergency rooms.

But with the rise in drug overdose deaths, there has been a growing push to equip more people with the protection.

The FDA said Evzio’s design makes it easy for anyone to administer. Once Evzio is turned on, it provides verbal instructions, much like defibrillators that laymen frequently use to help people who collapse with cardiac arrest. It is about the size of a credit card or small cellphone.

The antidote is not a substitute for immediate medical care, the FDA said, as anyone who has overdosed will need additional treatment.

Still uncertain is how much the antidote will cost. Executives of the drug’s manufacturer, kaleo Inc., of Richmond, Va., said it is too soon to say, but they are working with health insurers to get broad coverage.

Eric Edwards of kaleo said the antidote is intended not just for heroin or prescription drug addicts, but also for people who have accidental overdoses, unexpected drug interactions or are on very high doses of the drugs. People who overdose may suffer slower breathing or heart rates or loss of consciousness.

FDA Commissioner Margaret Hamburg said in a statement that 16,000 people die every year because of opioid-related overdoses, and that drug overdose deaths are now the leading cause of injury death in the United States, surpassing motor vehicle crashes. She said the increase in overdose deaths largely has been driven by prescription drug overdoses.

“While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives,” Hamburg said.

The announcement follows several state efforts to widen access to the antidote. At least 17 states, including Ohio, and the District of Columbia now allow naloxone — commonly known by the brand name Narcan — to be distributed to the public. Some of those states allow for third parties, such as a family member or friend of an intravenous drug user, to be prescribed it.

On Thursday, New York announced that every state and local law enforcement officer now will carry syringes and inhalers of naloxone.

Last month, Gov. John Kasich signed a law allowing police to distribute Narcan. Summa Lake Medina and Medina Hospital have made an arrangement with Medina police and squads from Medina and Montville Townships to arm officers with Narcan.

Thanks to a collaboration between the Cleveland Clinic and Summa Health System, taxpayers won’t have to foot the bill, said Dr. John Surso, who serves as the physician for the Medina Police Department, director of Summa Lake Medina and operates a family practice through the Cleveland Clinic’s Medina Hospital facility.

During a five-month-long pilot program in Lorain County, police used Narcan 30 times to revive 28 people. The success of the pilot program is what prompted state lawmakers to pass the legislation, said Medina Mayor Dennis Hanwell, who lobbied local state lawmakers to pass the law. Hanwell said the pilot program initially was intended to last a full year, but with heroin abuse on the rise, Hanwell said he asked state Sen. Larry Obhof, of Montville Township, and House Speaker Bill Batchelder, of Medina, to pass the law sooner.

“We wanted them to move along sooner,” Hanwell said. “If we have a chance to help save or prolong a life, we should be using those resources as best as we can.”

Staff reporters contributed to this story.