Anaesthetic Prexige is not permitted at the the American market
FDA experts have recognized Prexige produced by Novartis AG unsuitable for sale in the USA. This decision was not unexpected - recently this preparation has been withdrawn from sale in Australia in connection with possible influence on liver.
Now this preparation is sold in Europe; experts consider, that there it will not be withdrawn from the market in the foreseeable future. In USA Novartis plans to continue negotiations with FDA. Representatives of the company declare, that Prexige - «is a valuable preparation for treatment of pains at patients with osteoarthritis, who do not have contra-indications».
In Australia the preparation has been withdrawn from the market after eight registered cases of the serious side-effects connected to influence of the medicine on liver. In two cases patients died, in two more liver had to be grafted.
Prexige is allowed to sale in 50 countries of the world. For first half of this year its sale have made 52 million dollars. In its time the company hoped for the greater commercial success of a preparation.
Last month Novartis has informed the European doctors on new contra-indications to the treatment. Prexige now is not recommended for the patients, who suffer from diseases of liver, and who had similar diseases earlier, and also to patients who take other preparations influencing liver.