The Editorial Executive Committee welcomes letters, which should be less than 250 words. Before a decision to publish is made, letters which refer to a published article may be sent to the author for a response. Any letter may be sent to an expert for comment. When letters are published, they are usually accompanied in the same issue by their responses or comments. The Committee screens out discourteous, inaccurate or libellous statements. The letters are sub-edited before publication. Authors are required to declare any conflicts of interest. The Committee's decision on publication is final.
Letter to the Editor
Editor, -The article 'Should consumers be warned about aspirin, alcohol and gastric bleeding?' (Aust Prescr 2005;28:18-19) contains some peculiar logic. It suggests there is evidence that the risk of upper gastrointestinal bleeding is increased in patients consuming at least three to five drinks daily. However, it appears that commercial considerations dissuaded the Therapeutic Goods Administration (TGA) from adding an appropriate warning label to aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). The primary concern of the TGA should be the health and protection of the public, not the commercial interests of the pharmaceutical industry. Why should marketing considerations enter into the TGA's deliberations at all? Have we not learned from the rofecoxib debacle?
If, as the US Food and Drug Administration (FDA) concluded, there is a problem with moderate-high alcohol intake in combination with the use of aspirin/NSAIDs, then a warning statement for consumers is required. Equally, a similar warning should be required for paracetamol if there is good evidence of an increased risk of hepatotoxicity with alcohol consumption.
It may have been acceptable to conclude that a warning label is not currently warranted because the literature is not clear on alcohol increasing the risk of gastrointestinal bleeding due to aspirin/NSAIDs. However, it is bizarre to conclude that there is a real problem with moderate-high alcohol intake yet not warn consumers because of a need to maintain commercial parity in the analgesic market.
Clinicians are recommended to identify 'at-risk' patients. Would not this be easier if there was an appropriate warning label on analgesic packages, particularly as health professionals may have no knowledge of their patients' consumption of analgesics purchased at supermarkets and other retail outlets?
PhD Scholar, National Institute of Clinical Studies
Unit for Medication Outcomes Research and Education
School of Pharmacy
University of Tasmania
- http://www.tga.gov.au/docs/html/mecinfo.htm#member[cited 2005 July 4]
- Newgreen DB. Medicines Evaluation Committee review of non-prescription analgesics: an update. Canberra: Therapeutic Goods Administration; 2003. http://www.tga.gov.au/docs/html/analgupd.htm[cited 2005 July 4]