MHRA recalls St. John's Wort tablets due to contamination that may lead to liver damage

The Medicines & Healthcare products Regulatory Agency in the U.K. is recalling 91,800 packs of St John’s Wort tablets as a precaution because of product contamination that may lead to potential liver damage, according to a medical alert.

Various packages of the tablets were found to have levels of toxic pyrrolizidine alkaloid (PA) above the threshold recommended by the Committee on Herbal Medicinal Products (HMPC), a European expert body. The PAs can lead to symptoms of liver disorders including yellowing of the whites of the eyes and/or skin, nausea, vomiting, dark urine, abdominal pain and unusual tiredness, according to the alert.

Gerald Heddell, director of inspection, enforcement and standards division at MHRA said in the alert: “PAs are known to cause liver problems in humans. … If you are experiencing any of these symptoms you should tell your doctor straight away.”

The tablets affected by the contamination are from six packages with the following batch numbers: 14279, 14255, 14662, 14498, 14660 and 14523. Heddell recommends discontinuing use of the tablets from these batches immediately and returning them to the Herbal Research Company Ltd. Pharmacists or retailers that have these batches should remove them and return any remaining stock to their original supplier.

The release also states the high levels of PAs are not in the tablets themselves, but high levels are due to “accidental collection of local weeds during harvesting,” according to the release.

No safety issues have been reported to the MHRA to date.

Disclosure: Heddell is employed by the Medicines & Healthcare products Regulatory Agency.