Appendix A - GlaxoSmithKline press release

21 Sep 2012 - Public roundtable Arachnoiditis

GlaxoSmithKline (GSK) provided information to the Standing Committee on Health and Ageing’s public roundtable on Arachnoiditis through an ‘in- camera’ basis.

GSK has the utmost sympathy for the people who have been, and are, afflicted by arachnoiditis. Arachnoiditis is a complex condition that may be caused by a number of conditions such as spinal infections, surgery and trauma.

Myodil was an injectable dye used by doctors as a contrast medium for x-ray purposes in myelography and supplied by Glaxo from 1950.

Although a causal link between Myodil and arachnoiditis was not established, when the company became aware of a possible association, it included a precautionary warning in the Myodil product information sheet that there was a possible risk of arachnoiditis from the use of this medicine.

Myodil was not withdrawn from the market in Australia but discontinued in 1987 when newer diagnostic radiographic techniques became available.

All pharmaceutical products have side-effects, which doctors have to take into account by weighing them against the benefit to be gained by using the products.

In Australia, a court action around Myodil was launched against Glaxo and in 1999 Glaxo reached a settlement with claimants. The settlement was without admission of guilt. GSK is not at liberty to divulge the details of the settlement as these are confidential.

GSK believes that it acted responsibly at all times in relation to the supply of Myodil. Glaxo supplied this diagnostic product with the information available at that time to meet the needs of a very knowledgeable and specialist medical profession for many years, until it was superseded by newer products and technology.

GlaxoSmithKline is a global research-based pharmaceutical and healthcare company with a proud history in Australia dating back to 1886. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.