FDA announces mirtazapine tablet recall

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The US Food and Drug Administration (FDA) recently issued a MedWatch Safety Alert for one lot of mirtazapine 7.5 mg tablets.

The FDA says the manufacturer, Aurobindo Pharma USA, voluntarily recalled the lot on December 30, 2019, due to a label error. The company said that although the labels list the tablet strength as 7.5 mg, some bottles may contain 15 mg tablets.

Siobhan DeLancey, RVT, MPH, senior advisor for strategic initiatives at the FDA’s Center for Veterinary Medicine, told NEWStat that although this product is primarily prescribed for the treatment of major depressive disorder in humans, the FDA wants to get the word out to veterinarians because the drug is often used extralabel to treat undesired weight loss in cats whose owners prefer the tablet form.

DeLancey stressed that the recall “doesn’t have any relation to the approved animal product Mirataz.”

Mirataz (mirtazapine transdermal ointment), is a topical formulation that was approved for veterinary use in 2018.

Mirtazapine tablets are packaged in 500-count bottles. The affected lot number for both 7.5 mg and 15 mg mirtazapine tablets is 03119002A3, expiration date March 2022. The product can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle.

Signs of mirtazapine toxicity in cats include vocalization, agitation, vomiting, abnormal gait/ataxia, restlessness, tremors/trembling, hypersalivation, tachypnea, tachycardia, and lethargy.

“We encourage any veterinarians or veterinary technicians who note symptoms of toxicity or other adverse events to report to the FDA,” DeLancey said.

Photo credit: © iStock/Christian Horz