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Propylthiouracil shortage in Canada

thyoid

Propylthiouracil (PTU) is used to treat people with hyperthyroidism (overactive thyroid) who can’t take the first-line medication because they are pregnant, trying to conceive or have a drug allergy.

Canada’s only supplier discontinued the drug in December.

On June 18, Health Canada added a new supplier of PTU to its list of “designated drugs” that can be imported in exceptional circumstances.

According to the Canadian Society for Endocrinology and Metabolism (CSEM) — which wrote a letter to the federal health minister expressing “grave” concerns about the shortage and met with Health Canada this week — Phebra Canada has proposed to bring in a limited supply of PTU from Australia by July.

The group says a larger batch of the drug is expected in October.

You even can not imagination it, the whole Canada drug stores have no a single Propylthiouracil (PTU) pills.  Propylthiouracil is the only effective medicine for me. I asked the pharmacists about buying Propylthiouracil (PTU) in USA, they told me it is not legal to buy prescription Propylthiouracil (PTU) oversea. What should I do, my doctor can not do anything for me because I am allergy to the alternative prescription for hyperthyroidism.

I can do nothing but take multi-vitamin to take care of my illness. What a bad low effective government here in Canada.

Drug Shortage Report for PROPYL-THYRACIL

Last updated on 2020-06-16History
Report ID 106837
Drug Identification Number 00010200
Brand name PROPYL-THYRACIL
Common or Proper name PROPYLTHIOURACIL
Company Name PALADIN LABS INC
Market Status CANCELLED POST MARKET
Active Ingredient(s) PROPYLTHIOURACIL
Strength(s) 50MG
Dosage form(s) TABLET
Route of administration ORAL
Packaging size 100 tabs
ATC code H03BA
ATC description ANTITHYROID PREPARATIONS
Reason for shortage Disruption of the manufacture of the drug.
Anticipated start date
Actual start date 2019-12-11
Estimated end date Unknown
Actual end date
Shortage status Actual shortage
Updated date 2020-06-16
Company comments
Health Canada comments
Contact Address 100 BLVD ALEXIS-NIHON, SUITE 600
SAINT-LAURENT, QUEBEC
CANADA H4M 2P2
Company contact information

The only drug safe for pregnant women with serious thyroid disorders to take in the first trimester is no longer available in Canada, leaving doctors, medical organizations and the federal government scrambling to secure an alternative supply.

The discontinuation of the drug, propylthiouracil, known commonly as PTU, poses a major risk to pregnant patients with hyperthyroidism – or an overactive thyroid – caused by Graves’ disease, said Lois Donovan, endocrinologist and clinical professor at the University of Calgary’s Cumming School of Medicine. Graves’ disease is an autoimmune disorder that causes the thyroid to become overactive, and without treatment it can lead to heart, bone and other serious health problems.

“The downstream effects of not having this medication available are serious,” Dr. Donovan said.

The only alternative drug available, methimazole, causes birth defects in up to 10 per cent of pregnant women who take it during the first trimester, she said. The other treatment options, radioactive iodine and surgery, aren’t feasible either. Radioactive iodine is not safe to take during pregnancy and most operations have been postponed and delayed as a result of COVID-19, Dr. Donovan said.

Going without treatment increases the risk of miscarriage, premature birth, fetal heart problems and, in extreme cases, death of the mother and baby, Dr. Donovan said.

Until there is a solution in place, Dr. Donovan said she’s advising some patients with Graves’ disease to avoid pregnancy because of the potential risks.

“It certainly is upsetting,” she said. “We’ve talked about the alternative options, but most of those involve waiting … until we get a reliable source of this medication.”

Health Canada added PTU to its Tier 3 drug shortage list late last month. The list is reserved for shortages that “have the greatest potential impact on Canada’s drug supply and health care system.”

In an e-mail, a Health Canada spokesperson said the department is aware that some patients are having problems accessing the drugs and that it’s working to help secure another supply, such as from a foreign country.

Stan Van Uum, president-elect of the Canadian Society of Endocrinology and Metabolism, said he had a call with Health Canada officials Monday to discuss options to address the discontinuation. Dr. Van Uum said the federal government has identified a supply source outside of Canada, but it’s unclear how long it could take to get the drug here. The CSEM first wrote to the federal government about the drug discontinuation in late April.

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