Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.
Monthly Drug News
On March 29, 2023, the U.S. Food and Drug Administration (FDA) approved Emergent BioSolutions to sell Narcan® (naloxone) 4 mg/0.1 mL nasal spray over- the-counter (OTC). Used to reverse the effects of an overdose with opioid drugs, Narcan soon will be available to buy online as well as at convenience stores, gas stations and other easily accessible locations. However, implementation of labeling changes and administrative procedures may take several months before the switch is finalized and the OTC product becomes widely distributed.
It is used in emergency situations to resuscitate patients who are in respiratory failure after an acute opioid overdose. By blocking opioid receptors, it displaces the opioid drug and decreases the negative effects of a drug overdose. Its directions are to administer one dose (one spray) as soon as an overdose is observed or suspected. Emergency medical help should be requested immediately after giving the drug. If needed, one additional dose (in alternating nostrils) can be given every two to three minutes until professional assistance arrives. Few side effects are associated with the use of Narcan, but some patients may experience temporary constipation, headache and/or nausea. It is not effective for overdoses of non-opioids, such as methamphetamine; but it is not harmful if administered accidentally to a person who has not overdosed – someone who is unconscious as a result of very low blood sugar, for example.
Harm Reduction Therapeutics, a non-profit organization, also has requested OTC status for its 3 mg/0.1 mL nasal spray naloxone, RiVive™. The FDA is expected to rule on this application on or before April 28, 2023. Higher strengths and other dosage forms of naloxone will remain prescription only. Pricing information for OTC Narcan is not yet known.
Impact to Workers’ Comp
Considering the potential of misuse and overdose, opioid antagonists are of interest in those claims where an opioid is prescribed.
For any questions about the use of naloxone, opioids, and potential relatedness to a claim, please consult with your myMatrixx pharmacist.