Primus Pharmaceuticals advertises Limbrel as a prescription “medical food,” in a distinct category from supplements or prescription drugs.
This week, the FDA warned that Limbrel is an unapproved drug — but the FDA doesn’t have the authority to force Primus to recall Limbrel — and consumers should not take it because of the risk of side effects.
Patients with liver injury were reporting symptoms like jaundice, nausea, and fatigue. Patients with the inflammatory lung condition, called “hypersensitivity pneumonitis,” experienced fever, cough, and trouble breathing. Both conditions are potentially deadly.
The FDA asked Primus to voluntarily recall Limbrel on November 30, but it remains on the market.
In the meantime, the FDA says that anyone who is taking Limbrel should stop immediately and seek medical attention.
The agency is investigating 194 reports of people who experienced serious side effects after taking Limbrel. Of those reports, about 30 were determined to have been likely caused by Limbrel.
Primus continues to advertise Limbrel as safe. Their website states, “Unlike drugs, prescription medical foods generally do not cause severe adverse events or dangerous drug-on-drug interactions.”
Source: FDA urges maker to recall Limbrel after liver and lung injury reports