Alvogen Recalls Mislabeled Fentanyl Transdermal Patches

Alvogen Inc voluntarily recalled 2 lots of 12-[mu]g/h fentanyl transdermal patches in April. A number of cartons labeled 12-[mu]g/h fentanyl transdermal system patches actually contained a much higher dose of 50-[mu]g/h patches. The individually labeled patches themselves were correctly described on each individual package as having 50 [mu]g/h; however, they were in the incorrectly labeled cartons that indicated that each individual patch was 12 [mu]g/h.

The transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, Minnesota.

Application of a 50-[mu]g/h patch instead of a prescribed 12-[mu]g/h patch could result in serious, life-threatening, or fatal respiratory depression, the company announced in its recall communications to consumers.

Groups at potential increased risk could include first-time recipients of such patches, children, and the elderly. As of the announcement on April 21, Alvogen reported that it had not received any reports of adverse events related to this issue, according to the company announcement on the FDA website.

The affected lots include Lot 180060 and Lot 180073 of fentanyl transdermal system, 12 [mu]g/h, expiration date May 2020.

The mislabeled product is packaged in a 12-[mu]g/h primary carton. These lots of fentanyl transdermal system were distributed nationwide to the pharmacy level.

Alvogen announced that it notified its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Patients who have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to the point of purchase for replacement. Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to mailto:pharmacovigilance@alvogen. (See FDA. Alvogen Inc issues voluntary nationwide recall of fentanyl transdermal system due to product mislabeling. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts. Published April 21, 2019.)

Study Suggests Acetaminophen Could Dull Positive Empathy

Although it does not look like acetaminophen will be significantly deadening society, a second study has been published in a peer-reviewed journal suggesting a negative emotional effect from the drug.

A double-blinded controlled study published online in March in Frontiers in Psychology using a participant group of 114 undergraduate students at Ohio State University demonstrated that students who took a dose of 1000-mg acetaminophen reacted with slightly less positive empathy after reading scenarios about other people's positive experiences.

"These findings suggest that (1) acetaminophen reduces affective reactivity to other people's positive experiences and (2) the experience of physical pain and positive empathy may have a more similar neurochemical basis than previously assumed," the authors concluded. "Because the experience of positive empathy is related to prosocial behavior, our findings also raise questions about the societal impact of excessive acetaminophen consumption."

It should be noted that the dose taken by the participants is about twice what people normally take, and that the sample size is very small-only 57 students in each arm of the study. (See Mischkowski D, Crocker J, Way BM. A social analgesic? Acetaminophen (paracetamol) reduces positive empathy. Front Psychol. 2019;10:538. doi:10.3389/fpsyg.2019.00538.)

It should also be noted that an earlier study that included one of the same authors demonstrated in 2015 that acetaminophen blunted sensitivity to both negative and positive stimuli. (See Durso GRO, Luttrell A, Way BM. Over-the-counter relief from pains and pleasures alike: acetaminophen blunts evaluation sensitivity to both negative and positive stimuli. Psychol Sci. 2015;26(6)750-758.)