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FDA approves easy-to-use heroin overdose antidote

By Lauran Neergaard and Mary Clare Jalonick
Associated Press

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; anyone who has overdosed will need additional treatment.

Still uncertain is how much the antidote will cost. Executives of the drug’s manufacturer, Kaléo 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 Kaléo 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 due to 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 has largely 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 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, the state of New York announced that every state and local law enforcement officer will now carry syringes and inhalers of naloxone.



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