A popular anxiety medication taken by nearly 2 million Americans is being recalled nationwide due to a “life-threatening” packaging error.
Sixteen lots of the anti-anxiety drug clonazepam, sold under the brand name Par Pharmaceutical, are being recalled because they were printed with the wrong dosage on the label.
The recall, issued by manufacturer Endo Inc., affects prescriptions for 0.125 milligrams (mg), 0.25 mg, 1 mg, and 2 mg of orally disintegrating clonazepam tablets.
The incorrect dosage is printed on the box in which the medications are sold, and the correct dosage is printed on the blister strips and tablets inside.
Endo warned patients to stop taking the recalled products immediately, saying there was a “reasonable chance” they could suffer “life-threatening respiratory depression,” when breathing becomes dangerously slow.
Patients taking the maximum dose of clonazepam (2 mg), those with lung diseases, or taking other medications that can cause respiratory depression are said to be at greatest risk.
Pennsylvania-based Endo has blamed the error on an unnamed “third-party packager.”
There have been no reports of serious adverse events as a result of the error, the company said.
The image above shows the packaging of the Clonazepam medications that were recalled.
This is just the latest drug recall to hit the US, after 300,000 drugs for kidney conditions were pulled from the market last week over fears they could be contaminated with a cancer-causing ingredient, and that the Antidepressants were recalled last month over fears they contained a chemical used in rockets. fuel.
Patients who have the medication are urged to discard it immediately and contact their pharmacy for a replacement.
Those who have swallowed the recalled pills should contact their doctor immediately.
A total of 16 lots of the drug have been recalled, with each package containing 60 tablets packaged in 10 blister packs, each containing six pills.
It is not clear how many packages there are in a single batch.
Patients are urged to check the lot number of their medication, which is printed on the blister strips, to see if their dose is being recalled.
You can find a list of lot numbers. here.
In its voluntary recall, also released by the FDA, the manufacturer said: “Children and adults who inadvertently consume a higher dose of clonazepam may be at increased risk for adverse events such as significant sedation, confusion, dizziness, decreased reflexes, ataxia and hypotonia”. .’
The above shows the packaging of the Clonazepam medications that were withdrawn from the market. They were branded Par Pharmaceuticals.
Ataxia is the loss of muscle coordination, causing clumsy movements, and hypotonia is the decreased resistance of muscles to movement, making them appear flabby.
The manufacturer added: “There is a reasonable probability that significant and life-threatening respiratory distress will occur.”
“(This is) especially for patients with concomitant lung disease, patients who have been prescribed doses close to the maximum, and patients who are also taking other medications that could cause additional respiratory distress.”
Clonazepam is commonly prescribed to treat seizures, epilepsy, and panic disorders, a type of anxiety.
It works by raising levels of gamma-aminobutyric acid (GABA) in the brain, which helps calm the nervous system and cause muscles to relax.
More than 23 million prescriptions for this medication are issued each year in the United States.