Drug Shortages Update — December 5, 2021

Shortages are growing because of disruption caused natural disasters and ingredient supply issues, as well as increased demand for certain drugs.

Regulators have found that medications containing levetiracetam and clobazam have led to drug reaction with eosinophilia and systemic symptoms (DRESS), a rare and severe drug allergy.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, for prademagene zamikeracel to treat patients with recessive dystrophic epidermolysis bullosa.

This is the second recall of Sandimmune related to the formulation of crystals in some bottles.

Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.

Based on reports from post-marketing experience, Spravato’s warnings and precautions section now includes the risk of respiratory depression.