Home » Too many overdose deaths, FDA approves naloxone nasal spray without a prescription

Too many overdose deaths, FDA approves naloxone nasal spray without a prescription

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Too many overdose deaths, FDA approves naloxone nasal spray without a prescription

In one year in the USA over 100,000 died from opioid overdoses, especially Fentanyl. To stop this massacre, the FDA has decided to make a naloxone nasal spray “over the counter”, which counteracts the effects of drug overdose.

La Food and Drug Administration (FDA) first approved the use of a drug against theoverdose and opioids without a prescription. In practice, he has become a over-the-counter drug, which can also be sold in supermarkets, online, in petrol stations and wherever it is possible to buy this kind of product. The medicine in question is the naloxone hydrochloride (commercial name Narcan), administered as spray nasally in doses from 4 milligrams. It’s a real one drug life-saving, able to rapidly reverse the consequences triggered by opioid overdose, such as depression of the central nervous system and respiratory systemwhich can lead to the death of drug abusers.

But why did the US federal agency decide to approve such a drug without a prescription? The reason is the real massacre that opioids cause every year in the stars and stripes country. The FDA points out that only between October 2021 and October 2022 did they die over 100 thousand people due to opioid overdoses, especially synthetic formulations such as the notorious Fentanyl (or Fentanyl) illegal. It is a very powerful analgesic, about 100 times more powerful than morphine. It is used for chronic pain control and as an anesthetic in surgery, however it is also widely used as a narcotic substance, which triggers a very strong dependence. US drug overdose deaths skyrocketed during the pandemic of COVID-19it is also believed due to the devastating psychological impact caused by social isolation, lockdown, economic problems, bereavement and other consequences triggered by the spread of coronavirus SARS-CoV-2. Many people started abusing drugs and many of those who had come out fell back into the tunnel. It is estimated that about 70 percent of overdose deaths in the US are caused by synthetic opioids such as Fentanyl. Other potentially lethal opioids areheroin and theossicodoneboth of which can be “defused” by the Narcan.

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In light of this veritable massacre, the FDA has decided to intervene by making the drug capable of blocking the effects of widespread narcotics “over the counter”. However, the long-term consequences of this decision will all have to be evaluated. The free sale should take place within the summer, but only for the formulations administered in nasal spray, while those for injection and with different dosages they will remain under strict medical prescription for longer. “The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this transaction, the agency used its regulatory authority to facilitate greater access to naloxone by encouraging the development and approval of an over-the-counter naloxone product to address acute public health needs. , agency commissioner Dr. Robert M. Califf said in a news release. “Today’s approval of the over-the-counter naloxone nasal spray will help improve access to naloxone, increase the number of places where it is available, and reduce opioid overdose deaths across the country. We encourage the manufacturer to make product accessibility a priority by making it available as soon as possible and at an affordable price,” the executive added.

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Having it approved for use as an over-the-counter drug could have consequences with health insurers, who may decide they no longer cover it as a prescription drug. Also, because it could become much less profitable, some fear that manufacturers may stop making it. Two doses of naloxone retail for about $50. The FDA also stresses the importance of taking naloxone correctly, of which multiple doses may be needed to counteract the effects of an opioid overdose (which can last longer than those of the inhibitor). The US agency recalls that in people addicted to opioids, the use of the drug can trigger severe withdrawal symptomsincluding diarrhea, rapid heartbeat, nausea, vomiting, restlessness, tremors, fever, and many more.

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