Health Editor’s Note: You have probably seen this scenario at least once on a TV show or in a movie. A character is in convulsions, unconscious, foaming at the mouth, etc. and someone brings out a syringe and thrusts the needle into the person, usually through clothing which is weird to me since that would almost certainly lead to an infection at the injection site, and thrusts it into and arm or leg or squirts a spray up the nose and the person who has overdosed on narcotics dramatically regains consciousness and usually asks what happened. Well, this is not just for dramatics as a use of entertainment, but can really happen. Naloxone will reverse opioid/narcotic overdoses. As you can imagine, a drug that has the power to reverse a strong hit of narcotics, is something that could seem rather awesome to use. The FDA believes that if the instructions for use could be dumbed down, you know for anyone who could read, then naloxone could be sold over the counter (OTC) and every family, company, taxi and bus driver, train conductor, trucker, etc. could have some on hand for that time that someone overdoses. Could it be recommended that anyone who has access to narcotics, whether prescribed or illegally purchased should also carry OTC narcotic reversing agents? Only problem I see with that is that if the person who overdoses is by him or herself, which just might be the case, he or she will not be able to give/take the reversing agent as he or she will probably be unconscious and on the way to overdose death…..Carol
Naloxone Labeling Streamlined in Unprecedented Move
FDA tries to speed OTC Naloxone products
byContributing Writer, MedPage Today
The FDA announced new efforts to expand naloxone access Thursday by making it easier for companies to make over-the-counter (OTC) versions of the opioid overdose treatment.
Naloxone is not yet available OTC, prompting the FDA to try streamlining the label-development process by proactively creating two Drug Fact Label (DFL) templates to support OTC nasal spray and injectable products. DFLs are the consumer-friendly instructions that must accompany OTC drugs. Normally, applicants seeking approval for OTC status propose and test the DFL. This is the first time the agency has created and tested DFLs itself, said FDA Commissioner Scott Gottlieb, MD.
“One of the key components for OTC availability is now in place,” he said in a statement. “In short, we’ve crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access.”
The agency also conducted label comprehension testing to ensure the instructions were simple to follow. Some companies have said the requirement to perform comprehension studies had been a barrier to developing OTC naloxone products, Gottlieb said.
The FDA labels contain pictures showing how to use naloxone nasal sprays and auto-injectors. Product-specific instructions are not included and have not been tested by the FDA; companies will have to tweak the labels before they can be used. “Apart from this product-specific information, the model DFL otherwise contains all the key information needed for an untrained bystander to administer naloxone,” Gottlieb said.
The FDA announcement follows a Department of Health and Human Services recommendation last month that naloxone should be prescribed with opioids for patients at risk for overdosing. Last year, the U.S. Surgeon General issued a public health advisoryurging more Americans to carry and learn the drug. Most states allow naloxone to be sold without a prescription, but not all pharmacies carry it.