There's a new precaution section for Gleevec
The occasional occurrence of severe congestive heart failure and left ventricular dysfunction with use of imatinib (Gleevec) has prompted manufacturer Novartis to revise the Precautions section of the prescribing information. According to the company, most patients experiencing cardiac events had other comorbidities and risk factors, including a prior medical history of cardiac disease and advanced age. At-risk patients should be monitored carefully, and any patients with signs or symptoms consistent with cardiac failure should be evaluated and treated.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
