The Food and Drug Administration is evaluating cases of pediatric fever and dehydration associated with Exjade and Jadenu, iron chelating agents to treat iron toxicity.
The cases were identified in the quarterly (January-March 2017) Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS). A drug appearing on FAERS does not mean that the FDA has concluded that the medication causes the listed side effect. It means that the FDA has identified a potential safety issue. If under further evaluation the agency determines the drug is linked to the risk, the FDA may take a variety of actions including requiring changes to the drug’s safety label, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
Both Exjade and Jadenu contain the active ingredient deferasirox. Exjade is administered through oral suspension. Jadenu is given in the form of an oral tablet. The medication is used to treat iron overload caused by blood transfusions in adults and children at least 2 years of age. The drug is also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old.
Iron overload is a condition that increases the risk of cirrhosis and hepatocellular carcinoma, the most common type of primary liver cancer in adults and the most common cause of death in people with cirrhosis.
Any adverse events, including pediatric fever or dehydration, that may be associated with these drugs should be reported to the FDA FAERS at www.FDA.gov/MedWatch/Report.htm.
Source: FDA FAERS