Propylthiouracil (PTU) No Longer Made by Paladin

November 4, 2021 update: message from Accelera Pharma Canada Inc (APCI) to Health Care Professionals

Accelera Pharma Canada Inc (APCI), in partnership with Halewood Chemicals Ltd., has received approval for HALYCIL™ (propylthiouracil 50mg Tablets) and will be available soon for the following adult Indications:

For the medical management of hyperthyroidism.
In conjunction with radioiodine to hasten recovery while awaiting the effects of radiation.
For the control of thyrotoxicosis prior to surgery.
In the management of a thyroid storm in addition to other therapeutic measures.

The DIN number is: 02521059.

For more information, click here.

August 26, 2021 update: new interim supplier of PTU for Canada

Accelera Pharma Canada Inc. has received approval from Health Canada to import Propylthiouracil (PTU) 50 mg Tablets from Halewood Chemicals, a UK based company, as an interim measure to help mitigate the current shortage of propylthiouracil in Canada. This product now appears on the List of Drugs for Exceptional Importation of Sale for the treatment of hyperthyroidism.

This product is now available through pharmacies and is covered by several provincial and private plans throughout Canada. Propylthiouracil (PTU) 50 mg tablets can be ordered by pharmacies from their preferred wholesaler. The PIN (Pseudo Identification Number) is 09858135.

For further information about the product, including the Dear Health Care Practitioner letter, Summary of Product Characteristics and the Package Leaflet, please refer to the following link: https://halewoodchemicals.com/interim-supply-key-information-propylthiouracil-ptu-50-mg-tablets-imported-into-canada-on-an-interim-basis/.

December 1, 2020 update: “pseudo DIN” assigned

CSEM is aware that some patients may have trouble accessing coverage for PTU via their insurance companies. Because PTU is an Australian product that is imported through Health Canada’s interim Exceptional Importation rule, no DIN has been assigned. Ontario has issued a “pseudo DIN” that most provinces are using. The PIN number assigned to PTU is 09858122. Phebra Canada will begin its application process for a DIN beginning in January 2021 and expects Health Canada to complete an expedited review.

August 6, 2020 update: product available again — use the code for easier ordering

CSEM is aware that some pharmacies have been unable to find PTU. We have reached out to the manufacturer Phebra who assures us that PTU is available. Please see their message:

Dear Healthcare Professionals and stakeholders: | Chers professionnels de la Santé :

As you are aware, Health Canada added PTUTM (propylthiouracil) 50 mg tablets from Phebra to the List of Drugs for Exceptional Importation and Sale, as an interim measure to help mitigate the propylthiouracil shortage in Canada. PTUTM 50 mg tablets is now available for order at McKesson but over the last couple of days, we have been informed that some pharmacies have reported problems accessing PTU. | Comme vous le savez, Santé Canada a décidé d’ajouter les comprimés de 50 mg de PTUTM (propylthiouracile) de Phebra sur la liste des drogues destinées aux importations et aux ventes exceptionnelles. Cette mesure intérimaire vise à améliorer la gestion de la pénurie de propylthiouracile sur le marché canadien. Les comprimés de 50 mg de PTUTM sont disponibles pour commande chez McKesson mais certains pharmaciens ont signalé avoir eu des problèmes pour commander ce produit.

The following information should help with identifying PTU within the McKesson ordering system: | Les informations suivantes devraient vous aider à identifier le PTU dans le système de commande de McKesson :

McKesson code: 153473
description: PROPYLTHIOUR CO 50MG 100 AUS

If you have any questions, please don’t hesitate to contact us. | Si vous avez des questions n’hésitez pas à nous contacter. Nous vous remercions et vous souhaitons une bonne journée!

Phebra Canada Inc.
Tony Romagnino (514) 247-8383
Grazia Maion (514) 571-1750

July 29, 2020 update: PTU is now available

PTU™ (propylthiouracil) 50-mg tablets are now available. Your pharmacy can place an order with the distributor McKesson. Please take note that due to the limited quantities of product available short term, an inventory management program has been put in place. If you have urgent requirements, please contact your McKesson customer service representative to discuss allocation. Read the Letters of Introduction from Phebra:

Phebra has also provided this update with respect to PTU availability since the resupply in the week of July 13:

The demand for product over the first week has been minimal - less then 100 bottles were sold.
The current stock available at McKesson and Phebra should provide for country requirements until the end of August.
A second shipment of product is expected within the next 10 days (maybe sooner) and this inventory should provide coverage until the end of October 2020.
A third shipment is expected in October which will cover another 7 months.

July 10, 2020 update: supply expected end of second full week of July

Phebra Canada now has a limited supply of PTU available in Canada. They are working with the distributor McKesson to ship the medication to pharmacies as quickly as possible. Phebra reports that this 1 month supply will be allocated province by province based on percentage distribution of sales from previous years. Pharmacies can contact McKesson early in the week of July 13 and supply will be shipped to them within a day or two.

As this initial supply is limited, prescribers should continue to reserve PTU for the most urgent indications and limit Rx quantities to no more than 90 days at a time. Pharmacists may need to limit the quantity provided to weekly or monthly allotments depending on availability. Phebra will monitor the use of current supply and will provide product availability updates to Health Canada. CSEM will share these availability updates with members by posting them on our website.

Phebra also reports that they will be importing an additional 2 months' supply in August, and by October they anticipate having a full year's supply available. At least two other companies have also submitted proposals to Health Canada, so it is anticipated that there will be a sustainable Canadian supply of PTU by 2021.

Please check our website for regular PTU updates. CSEM is continuing to advocate for a sustainable supply of PTU for Canadian patients.

PTU update June 18, 2020: supply expected soon

CSEM continues to advocate for access to PTU for Canadian patients. We've had multiple calls with Health Canada and stakeholders, including manufacturers, wholesalers and pharmacy groups.

Health Canada has now approved Phebra Canada’s proposal to add Australian-authorized PTU™ (propylthiouracil 50-mg tablet) to the list of designated drugs for exceptional import and sale in Canada. Phebra Canada is working to bring in a limited supply of PTU in July, and will work with distributors and wholesalers to get it to market as soon as possible. In October, they anticipate a significant increase in supply to be available for Canada.

Other manufacturers have also submitted proposals to Health Canada, so it is expected that there will be a sustainable Canadian supply of PTU by 2021.

Health Canada is also working with wholesalers to determine the remaining inventory of PTU in Canada, and providing guidance to pharmacies to effectively manage the inventory.

Currently, we do not have information about how physicians can best access any remaining PTU or the new supply when it becomes available, but we will keep you informed. Please check our website for regular PTU updates.

May 29, 2020 update: CSEM is working with Health Canada

CSEM is engaged in ongoing meetings with Health Canada’s Drug Shortages Unit, Health Canada Provinces and Territories, and drug manufacturers to develop strategies to ensure an immediate supply of PTU, as well as a long-term, sustainable supply. On Monday, May 25, CSEM participated in a meeting of the Tier Assignment Committee (TAC) for propylthiouracil, which operates under the direction of the Multi-Stakeholder Steering Committee on Drug Shortages in Canada. As the ad hoc member of the TAC for this shortage, CSEM provided evidence to support the assignment of the PTU shortage as a Tier 3 shortage. Tier 3 shortages are the most serious classification of a shortage in Canada as they have the greatest potential impact on the drug supply, health care systems and the health of Canadians.

The following steps are being undertaken by Health Canada, with CSEM’s support and participation where warranted:

Assessment of the current supply of PTU across the country. Through initial outreach to manufacturers and wholesalers, Health Canada has confirmed that there is effectively no more supply of PTU in Canada.
Discussion with stakeholders, including Paladin Labs, and other manufacturers with expired DINs for PTU to encourage a Canadian company to restart manufacturing of PTU. Health Canada is not able to compel any company to manufacture a drug, however, this is the preferred long-term solution.
Exploration of the availability of PTU (approved and sold in a foreign country with a comparable regulatory system to Canada’s) for exceptional importation and sale in Canada.
Consideration of whether PTU can be imported expediently under the Minister of Health’s Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19.

We will continue to keep you informed as the situation evolves.

For patients who cannot use methimazole, you may consider the option of compounded propylthiouracil. Though very expensive, we have learned that some pharmacies can compound this drug.

The Special Access Program (SAP) is another option and some doctors have already begun this process. CSEM has strongly indicated to Health Canada that SAP cannot be the final solution given the often urgent need to start PTU, and considering that about 2,100 prescriptions for PTU are written each month in Canada.

April 29, 2020: propylthiouracil (PTU) no longer made by Paladin

The manufacturing of PTU has been discontinued by the sole Canadian provider, Paladin Labs. To our knowledge, PTU cannot currently be compounded, and there is no avenue to access PTU from different international suppliers. Challenges in accessing PTU have already been reported by patients.

CSEM recognizes the importance of this medication. We have contacted Health Canada (see attached correspondence) to implore them to ensure the availability of PTU in Canada. Please consider contacting your MP or the Minister of Health, Patty Hajdu, on behalf of Canadians who require this medication.

CBC News article: Alberta doctor fears for pregnant patients as supplies of key thyroid medication dwindle

Globe & Mail article: Officials scramble as drug for pregnant women with thyroid disorders discontinued in Canada

Related: Please see Health Canada's Summary Safety Review - Propyl-Thyracil (propylthiouracil): Assessing the Potential Risk of Birth Defects.