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Letter to the editor

Editor, – Roche Products recently announced plans to discontinue production of naproxen suspension in Australia.1 Their letter communicating these plans implies that rofecoxib suspension is a viable alternative. This is irresponsible, for several reasons, and demonstrates a clear lack of consideration of the best interests of children.

First, naproxen suspension is currently the most widely used non-steroidal anti-inflammatory drug (NSAID) in children with chronic arthropathies worldwide.2 It has a well-established efficacy and safety profile in children. The liquid formulation also has a convenient dosage schedule (twice daily) and is affordable. The only other NSAID with demonstrated efficacy and safety in children currently available in liquid formulation in Australia is ibuprofen. However, its lower effectiveness, need for more frequent dosing and greater cost are disadvantages in chronic therapy. The discontinuation of naproxen suspension will therefore mean that children will be unfairly disadvantaged by having their already limited NSAID options even further restricted.

Second, children's risk of significant gastropathy with NSAID therapy is negligible.3 There is therefore little rationale for considering a COX-2 inhibitor in the vast majority of children. Evaluable data regarding their safety/efficacy in children is lacking. The question of whether there is any gastrointestinal safety advantage with COX-2 specific inhibitors,4 the emerging safety concerns in adults,5 and the considerably higher cost, mean that rofecoxib suspension cannot be considered a 'viable alternative' to naproxen suspension for children.

It is time to stop treating children as second class therapeutic citizens and time to start paying more serious attention to ensuring that they have fair and equitable access to appropriate medications.

Madlen Gazarian
Paediatric Clinical Pharmacologist & Rheumatologist
Senior Lecturer, School of Women's & Children's Health, University of New South Wales
Sydney Children's Hospital
Randwick, NSW

Kevin Murray
President, Australian and New Zealand Paediatric Rheumatology Group
Consultant Paediatric Rheumatologist, Princess Margaret Hospital for Children
Subiaco, WA

Don Roberton
Professor
President, Royal Australasian College of Physicians (Division of Paediatrics)
Head, Rheumatology Service, Women's and Children's Hospital
Adelaide

Comments

Dr David Kingston, Medical Director, Roche Products, comments:

The decision to discontinue production of Naprosyn (naproxen) suspension on a global basis was made because of the discontinuation of one of the flavouring agents. This meant extensive reformulation work, stability testing and then registering the new formulation on a worldwide basis. The low use of Naprosyn suspension led to the decision to discontinue production. This left Roche Australia with no source of Naprosyn suspension. We have been trying to interest some local companies in producing naproxen suspension but so far there is no agreement to do so.

We are sorry that it has not been possible to arrange an alternative supply of naproxen suspension but are continuing in our efforts.

References

  1. Circular letter from Andrew Derijk, Mature Products, Roche Products Pty Ltd.
  2. Laxer RM, Gazarian M. Pharmacology and drug therapy. In: Cassidy JT, Petty RE, editors. Textbook of pediatric rheumatology. 4th ed. Philadelphia: WB Saunders Company; 2001.
  3. Keenan GF, Giannini EH, Athreya BH. Clinically significant gastropathy associated with non steroidal anti-inflammatory drug use in children with juvenile rheumatoid arthritis. J Rheumatol 1995;22:1149-51.
  4. Juni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior to traditional nonsteroidal anti-inflammatory drugs? Br Med J 2002;324:1287-8.
  5. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors [review]. JAMA 2001;286:954-9.