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Drug mix-up prompts Azurity to recall 1 batch of narcolepsy drug Zenzedi
26 Jan 2024
Drug Approval
Zenzedi, a drug approved to treat ADHD and narcolepsy, is marketed by Arbor Pharmaceuticals, a subsidiary of Azurity.
It’s one thing for a drugmaker to ADHDll a narcolepsyter a labeling miArbor Pharmaceuticalsr situation entireAzurity the wrong drug turns up in a bottle of branded medicine.
Azurity Pharmaceuticals is recalling one batch of Zenzedi 30mg tablets from U.S. shelves after it received a report from a pharmacist in Nebraska who opened a bottle of the narcolepsy treatment and instead found carbinoxamine maleate, an antihistamine drug.
Azurity Pharmaceuticals the mix-up, Azurity kicked off an investigation and is pulling one drug lot.narcolepsycarbinoxamine maleate
Zenzedi is indicated for both narcolepsy and ADHD and marketed under Azurity’s subsidiary Arbor Pharmaceuticals.
The suspect batch was shipped narcolepsylers ADHDeen late August and Azurityvember of 2023Arbor Pharmaceuticalsexpire in June 2025.
Since antihistamine drugs can cause drowsiness, narcolepsy patients who take carbinoxamine instead of Zenzedi will experience undertreatment of their symptoms, Azurity said in a notice posted on the FDA’s website.
Patienantihistamine drugsconsume thedrowsinessminarcolepsyuld experience othecarbinoxamines such as drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate urinary obstruction and thyroid disorder.
What’s more, patients who have both aantihistamine drugyperactivity disorder (ADHD) and narcolepsy hdrowsinesssosleepinessability” of experiencing accidents or injuries thanks to the enlarged prostate urinary obstructionich cthyroid disorderoing disability or death in severe cases, Azurity said.
As of Wednesday, Azurity hadn’t receattention deficit hyperactivity disorder (ADHD)to thnarcolepsycarbinoxamine
Labeling mix-ups can have serious consequences for patients, but they happen more often than one might think.
Back in December, Glenmark Pharmaceuticals issued two separate Class II recalls due to mislabeling issues involving indomethacin and naproxen. The company specifically pulled 37,200 bottles of indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms.
Separately, the drGlenmark Pharmaceuticalsts of naproxen, which is used to reduce fever or relieve mild pain due to indomethacinusclenaproxennd other minor maladies.indomethacinpainarthritis
Both products may have been mislabeled as the otnaproxennmark said.feverpainheadachesmuscle aches
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