Summary Safety Review - ENBREL (etanercept) - Assessing the potential harm to the developing babies of mothers treated with ENBREL

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2016-08-04

Product

Enbrel (etanercept)

Potential Safety Issue

Potential harm to the developing babies of mothers treated with Enbrel

Key Messages

  • Enbrel is used to treat inflammation of joints and skin which occurs when the body's own defence system attacks the joints and/or the skin, including certain forms of arthritis and psoriasis. The product information for Enbrel does not recommend use during pregnancy.
  • Health Canada carried out a safety review after receiving information from a study of a long-term pregnancy registry. In this study, Enbrel use during pregnancy was associated with fewer reports of miscarriages but a slightly increased chance of having a baby with a birth defect, compared to pregnant women who did not take Enbrel.
  • Health Canada will work with the manufacturer to update the product safety information for Enbrel to share information regarding what is known about the potential harm to a developing baby when mothers are treated with this medicine during pregnancy.

Overview

Health Canada carried out a safety review after receiving safety information from the manufacturer related to a long-term pregnancy registry study. In a pregnancy registry study, information is collected from women who take certain medications when they are pregnant and on the health and development of their newborn babies. The information collected from the registry can then be compared to with women who have not taken the medicine during their pregnancy. The product information for Enbrel states it has not been studied in pregnant women or nursing mothers, therefore its effects on pregnant women or nursing babies are not known, and that it should not be used during pregnancy unless the benefits outweigh the risks.

Use in Canada

  • Enbrel is a medicine which works by blocking a chemical produced in the body that causes pain and swelling (inflammation).
  • This medicine treats inflammation that results from the body's own defence system attacking its joints and skin (autoimmune diseases). Examples of autoimmune joint and skin diseases include ankylosing spondylitis, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and plaque psoriasis.
  • Enbrel is given through an injection under the skin and is available by prescription only.
  • Enbrel has been marketed in Canada since March 14, 2001.

Safety Review Findings

  • At the time of the review, Health Canada had received 7 Canadian reportsa of birth defects in the newborn babies of mothers treated with Enbrel. The babies had one of many kinds of abnormalities in parts of the body including the heart, skull and jawbone. Some reports noted that Enbrel crossed the placenta from the mother to the baby (in general, many medicines typically do). However, many of the women were also taking other medications, making it difficult to determine if Enbrel caused the birth defects.
  • The review of the pregnancy registry study, found that women treated with Enbrel had less miscarriages compared to those women not treated with Enbrel. The study also found slightly more reports of major and minor birth defects in children born to pregnant mothers treated with Enbrel than in children born to women not treated with Enbrel. There was no pattern or unique kinds of birth defects.
  • It was not possible to determine whether Enbrel itself caused birth defects because many of the women that were represented in the pregnancy registry took other medications while taking Enbrel.

Conclusions and actions

  • Health Canada's review noted that taking Enbrel during pregnancy was associated with a lesser risk of experiencing a miscarriage but a potential risk of carrying to full term a newborn with a birth defect. The review could not conclude that Enbrel by itself was the cause of birth defects.
  • Health Canada is working with the manufacturer to update the product safety information for Enbrel to share information regarding what is known about the potential harm to a developing baby when mothers are treated with this medicine during pregnancy.
  • Health Canada will continue to monitor safety information involving Enbrel, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new information on this risk is identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this treatment both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Online Database.

Report a problem or mistake on this page
Please select all that apply:
Date modified: