The US Food and Drug Administration (FDA) has detailed a safety plan for a class of drugs known as ESAs, which are used to treat chemotherapy-related anaemia despite studies that have shown they can actually make tumours grow faster.
In April 2008, the FDA required ESA manufacturer Amgen to establish a risk management programme based on studies that found that ESAs caused tumours to grow faster and resulted in earlier deaths in some cancer patients.
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The Risk Evaluation and Mitigation Strategy requires healthcare professionals to provide patients receiving an ESA with a medication guide that contains information on how to safely use a drug.
In addition, the company’s Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs programme requires specific training and certification of healthcare professionals who administer chemotherapy to patients with cancer and counselling of their patients.
FDA Centre for Drug Evaluation and Research director of the Office of Oncology Products Richard Pazdur said that evaluation of ESAs has been an ongoing and intensive process since 2004.
“This new risk management programme will help ensure that patients and their healthcare professionals have fully considered the benefits and risks of using ESAs,” Pazdur said.
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By GlobalDataESAs are approved for the treatment of anaemia that may occur as a result of kidney failure, from certain kinds of chemotherapy and from the drug AZT, which can be used for the treatment of HIV infection, and for the treatment of anaemia among certain patients undergoing surgery.
