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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 3 | Issue 22
November 15, 2021

Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Authorizes COVID-19 Vaccination in Children and CDC Updates Recommendations

On October 29, 2021, the U.S. Food & Drug Administration (FDA) authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in children ages 5-11 years, becoming the first COVID-19 vaccine authorized for this age group in the U.S. The FDA’s independent advisory committee was also involved in the decision-making process Clinical data showed that the vaccine, given at a lower 10 microgram dose (compared to the standard 30 mcg given to those 12 and older), was 90.7% effective in preventing COVID-19 in children ages 5-11 and provided comparable immune responses to individuals ages 16-25. The safety of the vaccination in children ages 5-11 was studied in approximately 3,100 children and no serious side effects have been detected as of the publishing of the trial results. With this approval, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has updated their recommendations to support the new FDA authorization of the Pfizer-BioNTech COVID-19 vaccine for emergency use to include children ages 5-11 years. Also on October 29, the CDC published a report which suggests that the immune response developed from a previous case of COVID-19 infection does not provide the same protection as a COVID-19 vaccine. Data analyzed showed that unvaccinated people who had previously recovered from infection were still five times more likely to get COVID-19 than those fully vaccinated with the Pfizer-BioNTech or Moderna vaccines. With this, the CDC is recommending that vaccination remains the most effective way to prevent COVID-19 infection. 

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Drug Safety

Methocarbamol Recalled Due to Mislabeling with the Incorrect Strength

On October 19, 2021, the FDA announced Bryant Ranch Prepack’s voluntary recall of a single lot of methocarbamol 500 mg tablets. The bottles labeled as 500 mg tablets were found to contain methocarbamol 750 mg tablets instead. Methocarbamol is a skeletal muscle relaxant with sedative properties. It is used in combination with rest, physical therapy and other measures for the relief of muscle spasms associated with acute pain in musculoskeletal conditions. In the event a patient were to take a 750 mg tablet instead of a prescribed 500 mg tablet, they would be at risk for experiencing a higher-than-expected level of sedation. This may result in nausea, fainting, falls, seizure, coma and even death. Bryant Ranch Prepack has not received any reports of adverse events since the recall. The company is notifying its distributors and customers that the lot has been recalled and has provided instructions for returning all recalled products. All consumers and patients who are in possession of the recalled product should discontinue use immediately and return the product to their pharmacy. Individuals who experience any problems related to using this product should contact their physician or health care provider for additional consultation. Adverse reactions or quality problems related to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

FDA Approves Zimhi™ for the Treatment of Opioid-Induced Overdose

On October 18, 2021, the FDA approved Zimhi™ (naloxone hydrochloride) for the treatment of opioid-induced overdose. Zimhi™ is available as a 5 milligram, single-dose, prefilled syringe, that is administered via injection either into the muscle or under the skin. Naloxone rapidly reverses the effects of an opioid by binding to and blocking opioid receptors, preventing any additional drug from exerting its effect. Opioid products include prescription pain relievers like oxycodone, hydromorphone and fentanyl. Zimhi™, like all naloxone products, can be administered by any individual, regardless of medical training, and should be given to any person who exhibits signs of an opioid overdose. Opioid overdose can be identified by the “opioid triad”, which consist of pinpoint pupils, unconsciousness, and respiratory depression (hypoventilation). Administration of a naloxone product can result in opioid “withdrawal” which can include symptoms such as nausea, headache, fever and sweating. Naloxone is not a treatment for opioid use disorder and has no effect on someone who does not have opioids in their system. This approval will offer an additional treatment option for opioid overdose which is still one of the leading causes of death in the United States.

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FDA Approvals

New FDA Drug Approvals

Novel Drug Approval: Scemblix® (asciminib)
Oral tablets approved for adult patients for the treatment of chronic myeloid leukemia (CML) with a specific chromosomal mutation which leads to abnormal white blood cell growth in the patient’s bone marrow. [10/29/21 – Priority Review; Orphan Drug – NOVARTIS PHARMS CORP]

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New Generics

New Generic Medications Entering the Marketplace

Azasan® (azathioprine)
Indication: Rheumatoid arthritis (RA) and prevention of rejection in kidney transplant
Dosage Form/Strength: 75 and 100 MG Tablets
Average Wholesale Price (AWP): Generic = $621 | Brand = $690