Autoinjected Midazolam Receives FDA Approval

The U.S. Food and Drug Administration (FDA) approved Midazolam 10mg/0.7mL autoinjector on Aug. 8, 2022. It is indicated to stop the extended seizures of status epilepticus in adults. Sustained seizures can cause permanent neurological damage. Since status epilepticus may be caused by nerve agents that could be used in combat situations, the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) of the U.S. Department of Defense partnered with Rafa Laboratories to develop the delivery device. Eventually, it will be the main convulsant antidote for nerve agent (CANA) in the U.S., succeeding diazepam 10mg autoinjectors, which is the current standard of care. A benzodiazepine that has been used for more than 35 years to produce and sustain sedation and anesthesia during invasive procedures, midazolam is a C-IV controlled substance. In the same way that an epinephrine autoinjector delivers the drug immediately, a Midazolam autoinjector can be used by a healthcare provider who is trained to recognize status epilepticus for giving an intramuscular (IM) injection into the patient’s thigh. Doses should not be repeated. A boxed warning cautions that using it or any other benzodiazepine along with opioids may cause respiratory depression, coma, and death.

Emergency Use Authorizations for New COVID-19 Boosters

Moderna and Pfizer/BioNTech each received FDA emergency use authorizations (EUAs) for a new type of COVID-19 vaccine booster on Aug. 31, 2022. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) gave approval for both of them the following day. The manufacturers already have begun sending them to doctors’ offices, pharmacies, and other vaccination sites. The new boosters are bivalent, which means that they can protect against the widely circulating BA.4 and BA.5 variations of the SARS-CoV-2 virus’ Omicron variation, as well as against its initial, Alpha form. COVID-19 vaccine, bivalent, from Moderna, is authorized for patients who are 18 years of age or older. Pfizer/BioNTech’s COVID-19 Vaccine, bivalent, can be administered to patients as young as 12 years old. Either is given as one shot at least 60 days following the patient’s last dose of the initial vaccine or a booster. Modern’s and Pfizer/BioNTech’s current monovalent (single-strain) vaccines are no longer authorized as boosters, except for children between the ages of five years and 11 years who still may receive the original Pfizer/BioNTech shot as a booster. The monovalent injections remain the standard for initial vaccinations as a two-dose series, however. The new boosters cannot be used for primary vaccination. A Prescriber’s Fact Sheet for Moderna’s bivalent vaccine is here; an updated one for patients and caregivers is here. Fact sheets on the Pfizer/BioNTech bivalent product are here for providers and here for patients and caregivers. Look here for general information on bivalent vaccines.

New Omeprazole Combination Approved

Konvomep^™ (omeprazole/sodium bicarbonate – Azurity Pharmaceuticals) oral suspension was FDA approved on Aug. 30, 2022. It contains both a proton pump inhibitor (PPI) and the antacid, sodium bicarbonate, for the treatment of adults who have active gastric ulcers that are not cancerous. It also is indicated to lower the risk of bleeding into the upper gastrointestinal (GI) tract for patients who have critical illnesses. For patients who cannot swallow, Konvomep can be administered through gastric tubes. To treat ulcers, the recommended dose is 40mg (20mL) once a day for one month to two months. To help prevent GI bleeding, the dose is 40mg per day for 15 days after two 40mg doses taken between six and eight hours apart on the first day. Taking a PPI may cause serious diarrhea. Other side effects may include abdominal pain, headaches, and nausea. Konvomep should not be used at the same time as clopidogrel, methotrexate, or rifampin. The launch is planned for the first quarter of 2023, but the cost has not yet been announced.