Drug Maker Recalls ADHD Medicine Over Label Mixup

The U.S. Food and Drug Administration last week announced the voluntary recall of a medicine used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy after the manufacturer of the drug revealed that the wrong pills were found in packages of the medication. The recall covers one lot of the drug Zenzedi, an ADHD and narcolepsy medication manufactured by Massachusetts-based Azurity Pharmaceuticals.

In a notice about the recall, the FDA noted that a pharmacist had reported finding pills of an antihistamine, carbinoxamine maleate, in a package of Zenzedi. The voluntary recall was announced by Azurity on January 24 and covers packages of Zenzedi 30 milligram tablets with lot number F230169A and an expiration date of June 2025.

The recalled medication was distributed nationwide through retail pharmacies. Pharmacies and drug wholesalers have reportedly pulled the drug from their shelves to comply with the recall. Customers who purchased packages of the recalled lot of Zenzedi are urged to return any remaining pills to the place of purchase. Patients who take the mislabeled medication and have adverse reactions are encouraged to see their doctor. 

The two drugs have opposite effects when taken, according to a report from CBS News. Carbinoxamine maleate is an antihistamine that is used to treat allergies and has a sedative effect on some patients, while Zenzedi, a brand name for the drug dextroamphetamine sulfate,  is a stimulant that generally increases a patient’s attentiveness. Zenzedi is used to treat narcolepsy, a sleep disorder that causes overwhelming daytime drowsiness, and ADHD.

The FDA added that patients who take carbinoxamine maleate instead of Zenzedi will experience undertreatment of their symptoms. Patients can also have a potentially deadly elevated risk of accidents or injuries and may have drowsiness, increased eye pressure, urinary obstruction and thyroid disorder, among other symptoms, according to the FDA’s recall notice.                                           

“Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury,” the FDA wrote in a notice about the recall. “Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.”

Azurity Pharmaceuticals sent recall notification letters to drug wholesalers on January 4 via an overnight letter and has arranged for the return of all affected product at the wholesale level. The company said that no reports of serious injury have been made as a result of the mixup.   

The Zenzedi recall comes in the midst of a nationwide shortage of medications used to treat ADHD. The shortage has been affecting supplies of the drug Adderall since a manufacturer experienced production delays in Fall 2022, according to a report from CNN.

At least 11 manufacturers of Adderall or generic versions of the drug were listed on the FDA’s shortage list in September 2023. The shortage of ADHD medication has left many patients struggling to fill their prescriptions, according to healthcare professionals. 

“A lot of the young people that I’ve been treating have had difficulties getting their medications month to month,” Dr. Warren Ng, a professor of psychiatry at Columbia University Medical Center who also serves as president for the American Academy of Child and Adolescent Psychiatry, told CNN.

When taking their prescribed medication, many patients with ADHD are able to function better. But when they run out of their medication, it can have a tremendous impact on their self-esteem.

“I’ve seen kids who want to drop out of school, don’t want to continue with their educational path or drop out of college suddenly making the honor roll,” Ng said. And “instead of seeing, being seen as being lazy or dumb or slow, they can envision themselves really utilizing all of their mental, psychological and intellectual abilities to really see themselves for who they are, which is so much more.”

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