In a move that was intended to help avert deaths caused by the nation’s addiction to prescription drugs, on Thursday the Food and Drug Administration decided to go ahead and approve a new device that would permit family or care givers to administer emergency medicines to battle any overdoses.
The product, which is known as Evzio, quickly gives a dosage of naloxone, which is a drug that has long been used to change the effects created by overdosing on a potent class of painkillers which are known as opioids to the reverse. The usage would be directed through an automatic injector, which is held in the hand. It would be tiny enough to put inside someone’s pocket.
Evzio could possibly end up preventing several of the 16,000 deaths per year that are ascribed to the abuse of painkillers. This is a problem which has become steadily worse over the last decade and now has left behind the number of individuals who die in automobile crashes. Because the victims of opioid overdoses usually lose consciousness before death, this allows either care givers or members of family to give naloxone outside of a hospital situation and this could easily mean the difference between living and dying for several people.
Overdose and death resulting from the mistreatment and abuse of prescription and also illegal opioids has become a major public health problem in the United States, explained Bob Rappaport, who is the director of the FDA’s division of analgesia, anesthesia and addiction products. He added that Evzio was the first combination of both drug and device that was made to carry a measured quantity of naloxone for administration outside of a health care location. By making the product available, it could end up saving more lives by enabling faster use of the drug in crisis situations.
Even though the FDA recommends that caregivers or members of family should become familiar with Evzio before they ever use it, the device instructs users on how to administer the drug inside if an emergency situation ever arises, much the same as an automated defibrillator does.
The naloxone is injected under the patient’s skin or into the muscle. The medication is designed to reverse the symptoms of opioid overdose, which include extreme fatigue, slow breathing and various changes in heart rate.
By approving the Evzio device, regulators warn that it must not be used as some sort of substitute for actual medical treatment, and that by using the drug, there can be serious opioid withdrawal symptoms, including vomiting, nausea, uncontrollable trembling, sweating and increased blood pressure and heart rate.
This approval comes among continuing reproach of the FDA over the recent announcement of a new opioid drug called Zohydro being put on the market. It would be the very first prescribed narcotic which containes a dosage of hydrocodone. That is the key element in the powerful drug known as Vicodin.
Before Zohydro, hydrocodone was only available in mixtures of non-addictive pain medicines, such as acetaminophen. The FDA approved a pure form for long-term usage without any chance of liver damage and would give much-needed pain management for chronic pain victims.
In the meantime, opponents have warned that such a creation will make the drug easier to abuse. They also contend that Zohydro’s lack of tamper resilient features, combined with its power, the strongest form contains at least ten times the volume of hydrocodone in most Vicodin pills, is nothing but a set-up for tragedy.
The FDA gave its approval for the debated drug in the fall of 2013 even though there was a large reference against it by its own advisory panel. The agency has continued to face pressure to reexamine its verdict from police officials, addiction specialists and lawmakers from either political party, though officials continue to defend its qualities as a quality painkiller.
In a move that will hopefully help avoid deaths caused by the nation’s addiction to prescription drugs epidemic, the Food and Drug Administration decided to approve a new device that would permit family or caregivers to administer emergency medicines to battle overdoses.
By Kimberly Ruble