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Pulse Newsletter

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

Volume 4 | Issue 13
July 1, 2022

Chief Authors: Bonnie Broczkowski & Colleen Peehler
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Authorizes Covid-19 Vaccine for Children 6 Months and Older  

On June 17, 2022, the U.S. Food and Drug Administration (FDA) extended emergency use authorization of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine for children as young as 6 months old. Previously vaccination was only authorized for children ages 5 years and older. This approval was granted following an evaluation of clinical trials of each product looking at safety and efficacy in children ages 6 months and older. Compared to the two-dose regimen for older age groups, the Pfizer-BioNTech COVID-19 vaccine, given to children ages 6 months through 4 years in three smaller doses, exhibited similar immune response. An initial dose is followed by a second dose after three weeks, and a third dose should be administered after another eight weeks. The Moderna COVID-19 vaccine follows the two-dose series schedule for both adults and individuals 6 months through 17 years old and showed similar immune response in all age groups studied. Doses are given one month apart, but the strength changes based on age range. For both products, the most commonly reported side effects were similar to those seen in other age groups, including pain, redness and swelling at the injection site, fever, muscle pain and fatigue. Additional reports in younger children included irritability/crying, loss of appetite and swelling/tenderness of the lymph nodes. The Centers for Disease Control and Prevention (CDC) recommends that all children ages 6 months through 5 years receive the vaccine, even if they have already had a COVID-19 infection.  

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Drug Safety

Plastikon Recalls Constipation and Heartburn Medications 

On June 8, 2022, the FDA announced that Plastikon Healthcare, LLC has voluntarily recalled certain lots of their products due to microbial contamination. These products include various formulations of milk of magnesia oral suspension and magnesium hydroxide/aluminum hydroxide/simethicone oral suspension. The products were distributed by and labelled as Major Pharmaceuticals, and they were shipped to hospitals, nursing homes and clinics nationwide. The use of these contaminated products could potentially result in increased risk of infection, which could lead to serious outcomes in patients with weakened immune systems. Plastikon is notifying its customers about the recall. Consumers who have the recalled products should stop using them immediately. Adverse reactions or quality problems relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program. To date, Plastikon has not received any reports of adverse events or injuries related to this recall. 

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From the Pharmaceutical Industry

Skyrizi® Approved for New Indication for Crohn’s Disease

On June 17, 2022, AbbVie announced that the FDA expanded approval for Skyrizi® (risankizumab-rzaa) for the treatment of moderate to severe active Crohn’s disease in adult patients. Crohn’s disease is a type of inflammatory bowel disease (IBD) characterized by inflammation in the digestive tract. Patients with Crohn’s disease often experience abdominal pain, severe diarrhea and weight loss. There is no known cure for Crohn’s disease, but patients may enter a symptom-free period, known as clinical remission, with proper treatment. Skyrizi® was originally approved for moderate to severe plaque psoriasis in 2019. Its approval was expanded to include the treatment of active psoriatic arthritis in January 2022. The safety and efficacy of Skyrizi® in the treatment of Crohn’s disease was evaluated in two randomized, double-blind, placebo-controlled induction (initiation of treatment) clinical trials, ADVANCE and MOTIVATE, and a maintenance clinical trial, FORTIFY. All three trials demonstrated significant achievement of either clinical remission of symptoms or an endoscopy confirmed disease state improvement of greater than 50% from baseline. Common side effects include headache, joint pain and injection site relations. The recommended starting dose for Skyrizi® when treating Crohn’s disease is a 600 mg intravenous infusion given monthly for three months, after which patients self-administer a 360 mg injection under the skin every eight weeks for maintenance treatment. Skyrizi® is the first drug in its class approved for Crohn’s disease. This approval provides gastroenterologists with an additional treatment option for adult patients with moderate to severely active Crohn’s disease.

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FDA Approvals

New FDA Approvals

Novel Drug Approval Amvuttra™ (vutrisiran)
Subcutaneous injection approved for the treatment of nerve damage in adult patients with a certain type of amyloidosis, which is a rare disease characterized by abnormal buildup of a type of protein called amyloids in the body. [06/13/2022 – Orphan Drug – ALNYLAM PHARMS INC]

New Dosage Form:  Skyrizi® (risankizumab-rzaa) 
Intravenous injection approved for induction treatment of moderate to severe active Crohn’s disease in adult patients. [06/16/2022 – ABBVIE INC] 

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New Generics

New Generics Entering the Marketplace

Viibryd® (vilazodone HCl)
Indication: Depression
Dosage Form/Strength: 10 MG, 20 MG, 40 MG Tablets
Average Wholesale Price (AWP): Generic = $297.50 | Brand = $378.18