The drugmaker sent a letter to healthcare professionals last week warning about severe kidney failure and deaths that have been reported in patients using Exjade, which removes excess iron from certain organs in patients receiving blood transfusions.

The side effects were found in post-marketing reports and mentioned on the FDA web site today. The agency noted tht most of the patients who died already had other complications and their illness was advanced. Exjade was approved in late 2005.

“The relationship of these episodes to treatment with Exjade is uncertain,” the agency says, adding that most patients already had disorders often linked to bone marrow failure. Other complications, including blood vessel inflammation, hives and hypersensitivity, were also reported. The FDA says Novartis has already included the new concerns on the drug’s label. T

Further reading…
Reuters;
FDA Medwatch alert;
Novartis letter to doctors.[tags]Exjade, Novartis[/tags]