A Broward company recalls a drug with an FDA black box warning about ‘suicidal thoughts’
About 112,865 bottles of an anti-depression and anti-anxiety drug that carries the FDA’s strongest warning has been recalled by its Weston-based distributor for a different problem than addressed by the warning.
Here’s what to know about Apotex’s recall of Paroxetine.
What Paroxetine is recalled and why is it prescribed?
▪ Though Apotex is based in the Broward County suburb 25 miles west of Fort Lauderdale, the company made all four recalled strengths of Paroxetine in Toronto. Each has an expiration date of 08/2024.
▪ 10 mg strength: 100-count bottles, lot Nos. RV2376 and RV2377; 1000-count bottles, lot Nos. RV2379 and RV2380; 30-count bottles, lot No. RV2375.
▪ 20 mg strength: 100-count bottles, lot Nos. RV2384 and RV2385; 1000-count bottles, lot Nos. RV2396 and RV2397.
▪ 30 mg strength: 100-count bottles, lot No. RV8686; 1000-count bottles, lot No. RX0119; 30-count bottles, lot No. RV2254.
▪ 40 mg strength: 1000-count bottles, lot Nos. RV0131, RV2387, RV2389, RW3296 and RV2388.
▪ In addition to depression and general anxiety, according to the National Library of Medicine, it’s designed to address social anxiety, panic attacks, obsessive compulsive disorder (OCD) and post-traumatic stress disorder (PTSD).
Why does Paroxetine have a ‘black box warning?’
As an antidepressant, Paroxetine carries the FDA’s most serious warning, a boxed warning also called a “black box warning.” It warns that there’s an increased risk of “suicidal thoughts” in children and young adults. Paroxetine isn’t supposed to be prescribed for children, although it can be prescribed for young adults.
“In pooled analyses of placebo-controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients,” the National Library of Medicine said. “There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.”
There were 14 additional cases of more suicidal thoughts per 1,000 people tested for those under 18 and five more cases per 1,000 tested for those aged 18 to 24.
Why is Paroxetine being recalled?
The FDA’s enforcement alert says the recall is happening because Amadori glucose, an inactive ingredient, tested out of acceptable specifications.
This is a Class II recall, which means using the drug “may cause temporary or medically reversible adverse health consequences” and “the probability of serious adverse health consequences is remote.”
What should you do now?
If you have any of the lot numbers recalled, take the bottles back to the pharmacy for an exchange or refund. Any medical problems should be taken to a medical professional, then let the FDA MedWatch program know either online or by calling 800-332-1088.
Other questions about this recall should be directed to Apotex at UScustomerservice@Apotex.com or 800-706-5575 from 8:30 a.m. to 5 p.m., Eastern time, Monday through Friday.
