Psychiatrist.comFDA Announces ADHD Drug Recall

A Closer Look at the Zenzedi Recall Amidst a National Shortage

In a recent development that underscores the complexities of medication safety and supply in the healthcare industry, Azurity Pharmaceuticals Inc. has voluntarily recalled a batch of Zenzedi CII 30 mg pills due to contamination with carbinoxamine maleate, an antihistamine. This incident not only poses direct risks to patients due to potential under-treatment of ADHD and narcolepsy but also highlights the broader issues of drug shortages and increased demand that have been exacerbated during the pandemic. This summary aims to distill key findings and implications for physicians to navigate these challenges effectively.

Key Points:

• Azurity Pharmaceuticals Inc. issued a voluntary recall for Zenzedi CII 30 mg pills due to contamination with carbinoxamine maleate, potentially leading to under-treatment of ADHD and narcolepsy symptoms.
• The contamination was identified when a Nebraska pharmacist discovered pills containing carbinoxamine maleate, an antihistamine, in a bottle of Zenzedi.
• Patients exposed to carbinoxamine may experience adverse effects including drowsiness, CNS depression, increased eye pressure, urinary obstruction, and thyroid disorder.
• The recall occurs amidst a nationwide shortage of ADHD medication, further complicating treatment options for patients.
• Research indicates a significant increase in demand for ADHD medications during the pandemic, particularly among young adults and women, with prescriptions for C-II stimulants and non-stimulant ADHD drugs jumping by 14% and 32%, respectively.
• The shortage has been attributed to supply constraints, manufacturing challenges, and federal regulations limiting production, with the DEA noting a shortfall of 1 billion doses in production potential.
• The pandemic has contributed to the surge in ADHD medication prescriptions, possibly influenced by the prevalence of “quick and dirty” self-diagnoses through social media and online platforms.

HCN Medical Memo
Zenzedi 30 mg tablets can be identified by light yellow hexagonal tablet debossed with ‘30’ on one side and ‘MIA’ on the other side and distributed in a white bottle with black writing and ‘30 mg’ highlighted yellow. The description of the suspect tablets was white round tablets with imprints of ‘GL’ on one side and ‘211’ on the other side.

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