FDA Recalls Chinese Medicine Drug for Lead Contamination
The FDA recalled “Side Head Regulator TT” tablets due to elevated levels of lead.
The FDA recently recalled Life Rising brand “Side Head Regulator TT” tablets due to lead contamination that could be poisonous to children.
The product is produced by Ton Shen Health of Chicago, and is a traditional Chinese medicine used to treat a variety of different headaches, including those occurring on the side of the head or behind the eyes.
The drug is said to pacify and regulate liver qi (liver energy), increase blood flow, clears wind, and relieves spasms. According to Life Rising, the drug contains sichuan lovage rhizome, dong-quai root tail, gambir vine, gastrodia rhizome, Chinese thorough-wax root, and earthworm.
However, recent lab tests also discovered that these drugs contain elevated levels of lead.
These high levels of lead can be damaging to children who are younger than 18-years-old, and are above the acceptable level of lead exposure for this population. Children are particularly susceptible to damage from lead poisoning.
Due to these findings, Ton Shen Health is recalling the product. They also decided to suspend the sale of this product in September 2016, according to a press release from the FDA.
Individuals with high levels of lead in the blood could potentially show no symptoms, but it can cause damage to both the nervous system and organs, the FDA said. Acute poisoning can cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, or decreased urine production.
Particularly in children, exposure to lead can cause permanent nervous system damage, which could result in learning and developmental disorders as well as other health problems.
Thus far, there have been no reports of adverse events associated with the “Side Head Regulator TT” tablets. The FDA reports that this recall is precautionary, but it is important for individuals to return or destroy this product before there is a chance for consumption by children.
The product was typically sold in the Chicago area, but was also distributed through the mail. “Side Head Regulator TT” tablets are packaged in a white plastic bottle with the UPC 616042101010 printed on it.
The FDA recommends that individuals who purchased the tablets return them to the place of purchase for a refund. Any adverse events should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program through the agency’s website.
Individuals who have taken the tablets should also discuss blood testing with their healthcare provider to determine any potential lead poisonings to prevent any long-term health effects.