Product Liability

FDA cautions about adverse events, deaths associated with anemia drug

The Food and Drug Administration (FDA) is notifying hemotology-oncology providers of an ongoing review of safety issues with Exjade (deferasirox), an oral medication used to treat patients aged 2 and older with chronic anemia and iron overload as a result of receiving blood transfusions. According to the early communication, new safety data suggests there may be a greater number of adverse events and deaths in patients using Exjade who are older than 60 years of age and who have myelodysplastic syndrome (MDS), a potentially fatal condition that can require frequent blood transmissions.

Patients with MDS and other chronic anemias may need frequent blood transfusions, which can lead to “iron overload,” or too much iron in the body. Iron overload can cause heart, liver or other organ damage. Exjade is often prescribed for such patients to address iron overload issues.

The FDA is working with Novartis, the makers of Exjade, to add new information on the Contraindications, Warnings, and Precautions sections of the prescribing information, and to alert health care professionals of the risks and adverse events associated with the medication. Adverse events include acute renal failure and gastrointestinal hemorrhages that in rare cases, especially in older patients with blood-related malignancies and/or low platelet counts, have been fatal.

The FDA is still determining whether patients with MDS or older patients treated with Exjade are at greater risk for adverse events or death compared to patients of a similar age or diagnosis who were not treated with Exjade, or compared to patients who are younger who have other chronic anemias and have been treated with Exjade. Patients who are taking Exjade should direct questions or concerns about the medication to their health care provider.

Adverse events experienced while using Exjade should be reported to the FDA’s MedWatch Adverse Event Reporting program.