Incomplete patient drug information still a problem
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* Robert G. Peterson

Traditionally, physicians and pharmacists have interpreted for patients the technical prescribing information provided by drug manufacturers and approved by Health Canada. More recently, it has become apparent that manufacturers should be providing information more oriented to consumers, to bridge the gap between the technical product monograph and information needed by patients. As a result, a new section of the product monograph, entitled “Information for the Consumer,” is required for all new submissions filed with Health Canada as of October 2004.

With regard to the situation raised by Sana Sukkari and Larry Sasich, in 1999 Health Canada notified health care providers, through its *Canadian Adverse Reaction Newsletter*, of 9 cases of hepatic dysfunction in Canada among patients receiving Serzone.1 In July 2001, Health Canada issued an advisory on the risk of severe hepatic injury with Serzone.2

The product monograph for Serzone was updated in October 2001 to warn of potential hepatoxicity. This update included a warning to patients that Serzone had been associated with very rare cases of severe liver damage. It advised patients being treated with the drug to seek immediate medical attention if they experienced any of the symptoms on the list provided.

Health Canada reviews and authorizies updates to product monographs and patient information for drugs sold in Canada, and drug manufacturers have a responsibility to ensure that the most recent versions of these documents are released to health care professionals. It appears, for reasons unknown to Health Canada, that the changes made to the 2001 product monograph and information to the consumer were not transmitted for the 2002 and 2003 editions of the *Compendium of Pharmaceuticals and Specialties*. The product was withdrawn from the Canadian market in 2003.

Health Canada continues to pursue initiatives to make product monographs, including information for the consumer, more readily available to the Canadian public. Certainly, the number of notifications to health care professionals about important safety issues — via the Health Canada Web site ([www.hc-sc.gc.ca/english/protection/warnings.html](http://www.hc-sc.gc.ca/english/protection/warnings.html)) and mailings — reflects the need for physicians and pharmacists to remain current with respect to the drugs they prescribe and dispense.

**Robert G. Peterson** Director General Therapeutic Products Directorate Health Products and Food Branch Health Canada Ottawa, Ont.

## References

1.  1. Hepatotoxicity associated with nefazodone (Serzone). *Can Adverse React Newsl* [serial online] 1999;9(3). Available: [www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adrv9n3_e.html#NEFAZODONE](http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adrv9n3_e.html#NEFAZODONE) (accessed 2004 Oct 4).
    
    

2.  2. *Risk of severe liver injury associated with use of the antidepressant nefazodone* [advisory]. Ottawa: Health Canada; updated 2001 Jul 9. Available: [www.hc-sc.gc.ca/english/protection/warnings/2001/2001\_74e.htm](http://www.hc-sc.gc.ca/english/protection/warnings/2001/2001_74e.htm) (accessed 2004 Oct 4).