Summary Safety Review - Isoniazid - Assessing the potential risk of inflammation of the pancreas (pancreatitis)

May 10, 2018

Product

Isoniazid

Potential Safety Issue

Inflammation of the pancreas (pancreatitis)

Key Messages

  • Isoniazid is a prescription drug authorized for sale in Canada to treat tuberculosis (TB), a disease caused by bacteria that mainly affects the lungs, although it may affect other organs or parts of the body.
  • Health Canada reviewed the potential risk of inflammation of the pancreas (pancreatitis) with the use of isoniazid. The review was triggered after the United States Food and Drug Administration (US FDA) updated the product safety information for isoniazid to include this risk.
  • Health Canada’s review found that there is a link between the use of isoniazid and the risk of pancreatitis.
  • Health Canada is working with the manufacturer to update the safety information for all isoniazid products to include information about this potential risk.

Overview

Health Canada reviewed the potential risk of pancreatitis with the use of isoniazid. The safety review was triggered because in the United States the product safety information for isoniazid was updated to include the risk of pancreatitis. Pancreatitis is an inflammatory disease of the pancreas and is most commonly caused by gallstones and alcohol use, but can also be caused by a drug reaction (drug-induced pancreatitis).

Use in Canada

  • Isoniazid is a prescription drug authorized for sale in Canada to treat TB, a disease caused by bacteria that mainly affects the lungs, although it may affect other organs or parts of the body.
  • Isoniazid can be used alone (prevention) or in combination with other anti-tuberculosis drugs for treatment.
  • Isoniazid has been marketed in Canada since 1997 under the brand name PDP-Isoniazid.

Safety Review Findings

  • At the time of the review, Health Canada had received 3 Canadian reportsFootnote a of pancreatitis in patients receiving isoniazid. In these reports, the timing of isoniazid use and the development of pancreatitis was either unclear or did not match the diagnosis of drug-induced pancreatitis. As such, Health Canada removed these 3 cases from further assessment.
  • Health Canada also reviewed 14 international published reports of pancreatitis and the use of isoniazid. Of these, 3 reports were considered to be likely linked to the use of isoniazid, 9 were possibly linked and 1 case was considered unlikely to be linked. The remaining report could not be assessed because there was not enough information.
  • The review also looked at the published scientific literature. These publications suggest that there is a link between isoniazid use and the potential risk of pancreatitis, although in some cases there may have been other factors that played a role in causing pancreatitis.Footnote 1Footnote 2Footnote 3Footnote 4
  • Both the US FDA and the European Medicines Agency (EMA) list the risk of pancreatitis in the isoniazid product safety information.

Conclusions and Actions

  • Health Canada’s review concluded that there is a rare potential risk of pancreatitis with the use of isoniazid.
  • Health Canada is working with the manufacturer to update the Canadian safety information on isoniazid products to inform about this risk.
  • Health Canada will continue to monitor safety information involving isoniazid products, 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 health risks are 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 drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

Footnote 1

Badalov N. et al. Drug-Induced Acute Pancreatitis: An Evidence-Based Review. Clin. Gastroenterol. Hepatol. 5, 648 (2007).

Return to footnote 1 referrer

Footnote 2

Balani A.R. & Grendell J.H. Drug-induced pancreatitis: Incidence, management and prevention. Drug Saf. 31, 823-837 (2008).

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Footnote 3

Prevent and manage drug-induced pancreatitis by identifying the offending agent and understanding the underlying mechanisms. Drugs & Therapy Perspectives 25, 19-22 (2009).

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Footnote 4

Gubergrits N., Klotchkov A., Lukashevich G. & Maisonneuve P. The risk of contracting drug-induced pancreatitis during treatment for pulmonary tuberculosis. J. Pancreas 16, 278-282 (2015).

Return to footnote 4 referrer

Footnotes

Footnote a

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

Return to footnote a referrer

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