Comparative analysis of the use and control of thalidomide in Brazil and different countries: is it possible to say there is safety?

ABSTRACT

Introduction

One of the biggest drug disasters in history has not prevented thalidomide from being used to treat various clinical conditions. Currently, Brazil has a worrying scenario: high consumption of the drug and, cases of pregnant women using thalidomide, even after adopting restrictive legislation.

Areas covered

This review of the literature and legislation sought to comparatively analyze the monitoring of thalidomide use in Brazil and other countries that use this drug. Finally, we discuss the differences between the countries.

Expert opinion

This analysis allows us to think beyond the safe use of thalidomide, but the safety provided by any type of monitoring system. It seems that out-patients that use unsafe drugs are exposed to some degree of risk. To improve safety, more extensive improvements are needed than monitoring systems related to the use of thalidomide. Its safe use depends on a drastic reduction in the incidence of leprosy and Erythema Nodosum Leprosum in the world; investment in research and development of safe and effective therapeutic alternatives to thalidomide; improvement of health systems and their health surveillance systems, particularly in primary health care; awareness of health professionals and patients for greater responsibility in the use of medicines, especially thalidomide.

KEYWORDS:

• Congenital abnormalities
• contraceptive agents
• drug
• drug approval
• guidelines
• legislation
• leprosy
• pharmacovigilance
• risk management
• thalidomide

Article highlights

The use of thalidomide continues to make victims of embryopathy in Brazil.

Unlike high-income countries, the use of thalidomide in Brazil is of great importance for public health due to the endemic occurrence of leprosy.

The effectiveness of the different models of monitoring systems reported in the literature to ensure the safety of the use of teratogenic drugs, such as thalidomide, is still questionable.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.