Developing countries, injection safety

Schmunis GA, Zicker F, Cmz JR, Cuchi P (2001) Safety of blood supply for infectious diseases in Latin American countries, 1994-1997. Am J Trop Med Hyg 65(6) 924-930 Simonsen L, Kane A, Lloyd J, Zaffran M, Kane M (1999) Unsafe injections in the developing world and transmission of bloodborne pathogens a review. Bull World Health Organ 77(10) 789-800... 

Because the older formulation of diclofenac for parenteral injection was approved in the UK decades ago and marketed there continuously since, with ample experience as to its safety and efficacy, the regulatory pathway for approval of the new formulation in that country as an essentially similar product was relatively straightforward. The new formulation was approved and has been marketed in the UK since late 2007 for parenteral use, 75 mg every 12 hours as needed for the treatment of acute moderate to severe pain. This dose, dosing interval, and indication are the same as for the earlier formulation. Other European submissions are planned and our new formulation of injectable diclofenac is currently under clinical development in the USA. Because no injectable diclofenac has previously been approved in the USA, the US clinical development program has been more comprehensive than that in the UK, including clinical trials that have assessed various doses and dose intervals in several pain models and in subjects ranging from healthy normal subjects to post-surgical patients, and patients with renal or hepatic insufficiency. 

---