Propylthiouracil (PTU) No Longer Made by Paladin
PTU update July 29, 2020: 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.
PTU update July 10, 2020: 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.
PTU update May 29, 2020: 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.
Related: Please see Health Canada's Summary Safety Review - Propyl-Thyracil (propylthiouracil): Assessing the Potential Risk of Birth Defects.