Companies’ statements about drugs withdrawn from the Canadian market: A descriptive analysis

Abstract

BACKGROUND:

Companies often defending their products when there are concerns about their safety and/or effectiveness.

OBJECTIVE:

This study looks at drugs removed from the Canadian market from 1990 onward and examines how companies responded.

METHODS:

This descriptive analysis used a previously published article and a hand search of a Government of Canada website to generate a list of drugs withdrawn from Canada from 1990 onwards. For each product the following information was extracted: brand name, generic name, company, date of withdrawal and evidence base for withdrawal. Google and Factiva searches were used to identify sources containing statements from the company about the withdrawal. Statements were independently graded by two people into the following categories: company agrees with the withdrawal; drug could be used safely with certain precautions; company may reintroduce the drug; company disagrees with the withdrawal. Searches were carried out between September 15–20, 2020.

RESULTS:

There were 22 drugs for which there were company statements. In 10 statements, the companies disagreed with the decision to withdraw the drug and in 7 they agreed with the decision. In the other 5 cases they felt that the drug could have been kept on the market with restrictions (2 cases) or they might reintroduce the drug (3 cases). The level of evidence for the withdrawal did not seem to influence the companies’ position.

CONCLUSION:

In 15 out of 22 cases, the company either disagreed with the decision to withdraw the drug or felt that the drug should continue to be available to Canadian patients.