A drug used to treat ADHD and narcolepsy has been recalled after other pills were found in a bottle of the drug.
The Food and Drug Administration announced a voluntary recall Wednesday by manufacturer Azurity Pharmaceuticals, saying that “a pharmacist in Nebraska … opened a bottle of Zenzedi 30 mg tablets and found tablets of carbinoxamine maleate, an antihistamine.”
Zenzedi is a stimulant medication, which the Mayo Clinic explains is “typically the most commonly prescribed medication for ADHD.” It is also used to treat narcolepsy, a sleep disorder characterized by drowsiness and sudden falling asleep during the day.
However, the antihistamine in the bottle “has sedative properties,” according to the National Institutes of Health.
A bottle of Zenzedia.
FDA
And as the FDA warns in its recall notice, “there is a reasonable likelihood that accidents or injuries occurring due to the sedative effects of carbinoxamine could result in permanent disability or death in severe cases, particularly if individuals using it (are unaware that they have not received Zenzedi) engaged in activities that require significant focus and alertness (eg driving, operating heavy machinery).”
The two drugs look very different, and Zenzedi is a yellow, hexagonal pill with “30” on one side and “MIA” on the other. The carbinoxamine maleate tablets found in the stimulant bottle were white and round, with “GL” on one side and “211” on the other.
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The recalled Zenzedi has lot number F230169A, with an expiration date of June 2025.
The United States still faces a drug shortage for ADHD, a more common abbreviation for attention deficit hyperactivity disorder, which “involves a combination of persistent problems, such as difficulty maintaining attention, hyperactivity, and impulsive behavior,” the Mayo Clinic explains.
Although ADHD is characterized by hyperactivity, stimulants are most commonly prescribed to treat symptoms.
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Zenzedi is small and yellow.
FDA
“Despite their name, stimulants don’t work by increasing your arousal,” explains the Cleveland Clinic. “Rather, they work by increasing the levels of certain chemicals (neurotransmitters) in your brain called dopamine and norepinephrine. These neurotransmitters play an important role in your ability to pay attention, think, and stay motivated. Studies have shown that approximately 80% of children with ADHD have fewer symptoms after finding the right stimulant and dosage.”
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Not taking ADHD stimulant medication regularly “can lead to withdrawal while also increasing ADHD symptoms,” A very good mind wrote.
However, at the time of the FDA’s announcement, no “serious adverse events associated with this recall” had been reported.
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Categories: Trends
Source: HIS Education