Multiple unauthorized L-tryptophan and lithium orotate products sold on amazon.ca may pose serious health risks

Starting date:

May 30, 2017

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Identification number:

RA-63436

• 
  Issue
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Affected products
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing

Issue

Health Canada is advising Canadians that multiple unauthorized products labelled to contain L‑tryptophan or lithium orotate were being sold on amazon.ca, and may pose serious health risks. L‑tryptophan (at doses higher than 220 mg per day) and lithium orotate are prescription drugs in Canada and should be used only under the supervision of a health care professional.

All drug products sold in Canada, including those sold over the Internet, must be approved for sale by Health Canada. Taking drugs that have not been authorized by Health Canada may pose serious health risks as they have not been assessed for safety, effectiveness or quality.

Prescription drugs should be obtained only from pharmacies that are licensed by the applicable province or territory in which they operate. Consumers who take a prescription drug without being examined and monitored by a health care professional may not receive appropriate treatment. They may also put themselves at risk for harmful drug interactions and dangerous side effects.

What you should do

• Individuals taking these products should consult with their health care professional to receive advice on safely discontinuing use of these products, and on appropriate treatment for their medical condition.
• Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.
• Report adverse events to health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Who is affected

• Consumers who have bought or used the affected products

Background

L-tryptophan is a prescription medication at doses higher than 220 mg per day. At these prescription doses, this medication should be used only under the supervision of a health care professional because of the higher risk of serious side effects and harmful drug interactions. L-tryptophan is prescribed in Canada for use in combination with antidepressants for patients with depressive disorders. Side effects of L-tryptophan include dry mouth, dizziness, nausea, headache, and sexual problems. In rare cases, serotonin syndrome has been reported when L-tryptophan is taken with other drugs that affect the central nervous system. Serotonin syndrome is a potentially life-threatening reaction with symptoms that include high body temperature, agitation, sweating, rapid heart rate and high blood pressure, muscle rigidity, confusion, and seizures.

Lithium is a prescription drug and is approved for treatment of manic episodes of manic-depressive illness. Common lithium side effects include increased thirst and urination, hand tremors and drowsiness. Severe dehydration has been reported. Intoxication can occur, especially when taken with other medications. Symptoms of intoxication can include vomiting, diarrhea, muscle twitches and lethargy. Patients should take lithium only after receiving a diagnosis and prescription from a health care professional. Otherwise, patients risk inappropriate treatment for their condition and harmful drug interactions or side effects.

Affected products

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866-225-0709

What Health Canada is doing

As requested by Health Canada, Amazon has removed these products from its website. Health Canada is following up with identified sellers and will take action to remove products from sale and inform Canadians, as appropriate. When Health Canada identifies unauthorized health products being sold online, the Department works with the company to stop the sale of the products and informs Canadians, as appropriate.