Drug Maker Recalls ADHD Medicine Over Label Mixup

Last week, the U.S. Food and Drug Administration announced a voluntary recall of drugs used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy. The drug's manufacturer revealed that the wrong pill was included in the drug's packaging. The recall involves one lot of ADHD and narcolepsy drug Zenzedi, manufactured by Massachusetts-based Azurity Pharmaceuticals.

in news Regarding the recall, the FDA noted that a pharmacist reported finding tablets of carbinoxamine maleate, an antihistamine, inside a package of Zenzedi. The voluntary recall was announced by Azurity on January 24 and involves packages of Zenzedi 30 mg tablets with lot number F230169A and an expiration date of June 2025.

The recalled drugs were distributed nationwide through retail pharmacies. Pharmacies and drug wholesalers reportedly removed the drug from their shelves to comply with the recall. Customers who purchased packages of Zenzedi from the recalled lots are urged to return any remaining pills to their place of purchase. Patients who take an incorrectly labeled medication and experience side effects are advised to seek medical attention.

drugs have adverse effects

According to one researcher, the two drugs have opposite effects when taken. report From CBS News. Carbinoxamine maleate is an antihistamine used to treat allergies and has a sedative effect in some patients, but Zenzedi, the brand name for the drug dextroamphetamine sulfate, is generally a stimulant that increases patient alertness. It is a drug. Zenzedi is used to treat narcolepsy, a sleep disorder that causes overwhelming daytime sleepiness, and his ADHD.

The FDA added that patients who take carbinoxamine maleate instead of Zenzedi will have their symptoms inadequately treated. According to the FDA's recall notice, patients are potentially at increased risk of accidents and injuries and may experience symptoms such as drowsiness, increased intraocular pressure, urinary tract obstruction, and thyroid problems.

“Patients who take carbinoxamine instead of Zenzedi® may experience inadequate treatment of their symptoms, which may result in impairment and increased risk of accidents and injuries,” the FDA said in its recall notice. writing. “Patients who unknowingly take carbinoxamine may experience adverse events including drowsiness, drowsiness, central nervous system (CNS) depression, increased intraocular pressure, enlarged prostate, urinary tract obstruction, and thyroid disorders.”

Azurity Pharmaceuticals sent the recall notification to pharmaceutical wholesalers in an overnight letter on January 4 and arranged for the return of all affected products at the wholesale level. The company said there have been no reports of serious injuries as a result of the mix-up.

Recall occurs due to shortage of ADHD medication

The Zenzedi recall comes amid a nationwide shortage of the drug used to treat ADHD. The shortage has affected the supply of the drug Adderall since the manufacturer delayed production in the fall of 2022, CNN reported.

In September 2023, at least 11 manufacturers of Adderall or generic versions of the drug were placed on the FDA's shortage list. Medical experts say a shortage of ADHD drugs means many patients are struggling to fill their prescriptions.

“Many of the young people I have treated have had difficulty obtaining their medications each month,” says Dr. Warren Ng, professor of psychiatry at Columbia University Medical Center and president of the American Academy of Child Sciences. adolescent psychiatry, told CNN.

Many people with ADHD are able to function better when they take prescribed medications. But when the medication runs out, it can have a huge impact on self-esteem.

“I've seen kids who want to drop out of school, who don't want to pursue a career in education, or who drop out of university and suddenly find themselves on the honor roll,” Ng said. And, “Instead of looking and being seen as lazy, stupid, or slow, you can actually use all of your mental, psychological, and intellectual abilities to truly see yourself as you are. That’s wonderful.”