The Growing Safety Concern of Alpha Lipoic Acid and Hypoglycemia: Marketed Health Products Directorate Issues ALA Summary Safety Review

August 2, 2016 By

The Growing Safety Concern of Alpha Lipoic Acid and Hypoglycemia

August 08, 2016 Marketed Health Products Directorate provides Summary Safety Review for Alpha Lipoic Acid.

In an effort to increase transparency and consumer safety, Health Canada’s Marketed Health Products Directorate published a Summary Safety Review (SSR) on Alpha Lipoic Acid (ALA) on June 30, 2016. ALA is a medicinal ingredient generally used, in Natural Health Products (NHPs), as an antioxidant for the maintenance of good health and to help promote healthy glucose metabolism. ALA can also be used in NHPs, as a non-medicinal ingredient, with a preservative function. To date, Health Canada has licensed more than 800 NHPs containing ALA as a medicinal ingredient.

The Health Canada SSR issuance on ALA was prompted by reported international cases of Insulin Autoimmune Disorder (IAS) considered to be linked to the use of ALA containing products. IAS, also known as Hirata disease, is a rare case of serious and spontaneous Hypoglycemia. It is characterized by extremely low blood glucose, and extremely high insulin and insulin autoantibody levels. Current evidence suggests exposure to certain sulfhydryl-containing oral drugs such as ALA, in individuals with specific genetic predispositions, can induce Hypoglycemia and increase the risk of IAS. The reported cases demonstrate Hypoglycemia resolution following discontinuation of ALA oral consumption. At the time of the review, no Canadian cases of Hypoglycemia were reported as a result of ALA oral use. It is however unknown how prevalent the suspected genetic predisposition may be in the diverse Canadian population.

As a result of the SSR findings, Health Canada is looking into updating the ALA labelling standard risk information to inform consumers to discontinue product use and consult a healthcare professional if they experience symptoms indicative of Hypoglycemia (sweating, paleness, chills, headache, dizziness and/or confusion). Health Canada has also committed to publish a Health Product InfoWatch article to raise awareness of this potential risk and continue to monitor safety information involving ALA.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the health sciences and food industries. We evaluate, implement, and provide all the necessary support for your products and operations to gain market access and build confidence in your brand.