FDA Warns Against Use of Unapproved HCT/Ps

The Food and Drug Administration’s Center for Biologics Evaluation and Research issued a patient and consumer warning March 12 urging the public to avoid using unapproved products derived from human cells or tissues (HCT/Ps).

The communication follows reports of a patient death after injecting themselves with Laennec, an unapproved placental tissue–derived product that was sold online. FDA said it is investigating the incident.

In the notice, FDA cautioned that some clinics and companies market HCT/Ps without evidence of safety and effectiveness, which may pose serious risks to consumers. The agency also instructed patients and clinicians to report any adverse events related to the use of human placental tissue–derived products to the agency’s MedWatch Adverse Event Reporting Program.