Black Box Warning Added About Side Effects of Exjade

The FDA has announced that it is requiring a new “black box” warning to alert patients to the potential dangers of Exjade side effects, an iron-reducing medication made by Novartis AG, which could increase the risk of kidney problems, liver problems and gastrointestinal bleeding.

According to a statement posted Thursday on the FDA MedWatch website, the new label will contain a boxed warning indicating that Exjade may cause renal impairment, including kidney failure, hepatic impairment, including liver failure, and gastrointestinal hemorrhage. Among some reported cases, these problems with Exjade were fatal.

The warnings come approximately five months after the FDA issued an early communication in September 2009 to alert healthcare professionals that they were reviewing the potential side effects of Exjade.

Exjade (deferasirox) is an iron chelating medication manufactured by Novartis for people with chronic anemia and iron overload due to a blood transfusion. It was approved by FDA in November 2005, and generated $531 million in sales in 2008.

In 2007, the FDA warned that the drug could cause kidney failure and had resulted in at least eight deaths. The drug’s warning label was subsequently updated to include risks of kidney failure, blood vessel inflammation, hives, and hypersensitivity.

In the most recent safety review, the FDA looked at adverse event data for Exjade and data from a global safety database. The agency concluded that that older patient suffering from myelodysplastic syndrome (MDS) may face a greater risk when compared to younger patients with other chronic anemias.

MDS is a disorder where the patient’s bone marrow does not create enough normal blood cells, resulting in anemia. Those with MDS often need regular blood transfusions, which can cause a buildup of iron in the blood known as iron overload. Iron overload can cause damage to the heart, liver and other organs.

The new warning suggests that doctors closely monitor patients taking Exjade. In particular, they should watch for changes in creatinine levels, as well as changes in the levels of transaminases and bilirubin.