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Coumadin®: Discontinuation of Sale

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Dr. Stephan Moll and Beth Waldron write (last updated April 28, 2020):

The company making Coumadin® (warfarin sodium) tablets, Bristol-Myers Squibb (BMS), announced that it will discontinue the sale and distribution of Coumadin® (see the FDA filing here). A memo on the BMS website says:

“all strengths of Coumadin® (warfarin sodium) tablets will be discontinued in the United States, Canada, Latin America, and Saudi Arabia, due to an unexpected manufacturing issue that could not be resolved expeditiously. Based on stock availability and expiration dates, we anticipate discontinuation of Coumadin® strengths to begin on June 1, 2020. Full discontinuation of all strengths is expected by August 31, 2020.

This voluntary action is the result of an unexpected manufacturing issue that cannot be resolved and is not the result of any quality, safety or efficacy issue regarding the product.”

Joseph Atallah, Head of Medical Affairs for BMS-Canada

The company encourages physicians to contact patients who are taking Coumadin® to explore alternatives.

Source: https://www.bms.com/ca/en

Alternatives

The discontinuation announcement applies to brand name Coumadin® only. Brand Jantoven® and generic warfarin remain available. However, it is unclear if the manufacturing issue which impacted Coumadin® will also affect Jantoven® and generic warfarin production at some point in the future. Prescription drugs have a complex supply chain and the FDA only learns of a drug shortage or discontinuation when notified by the manufacturer after the fact, making it nearly impossible to predict which drugs will come into short supply in the future.

Alternatives to Coumadin® which patients and their physicians may wish to consider at the present time (4/28/20) include:

  • Jantoven® (warfarin sodium), a branded warfarin manufactured by Upsher-Smith.
  • Generic wafarin (warfarin sodium). There are 13 manufacturers on file with the FDA to produce generic warfarin.
  • Direct-acting oral anticoagulants (DOACs): Eliquis®(apixaban), Pradaxa®(dabigatran), Savaysa™(edoxaban), and Xarelto®(rivaroxaban).

A comparison chart of the oral anticoagulant options can be found, here.

Generic warfarin

The most straightforward solution may be to switch from brand name Coumadin® to the branded Jantoven® (warfarin sodium) or generic wafarin.

Generic warfarin has been found to be as safe and effective as brand name Coumadin® (REF 1). When switching from brand name to generic, closer monitoring of a patient’s INR may be reasonable as variations in an individual’s INR response may be seen.

REFERENCES

  1. Dentali F, Donadini MP, Clark N et al. Brand Name versus Generic Warfarin: A Systematic Review of the Literature. Pharmacotherapy Volume 31, Number 4, 2011.

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