Cancer patients will learn more from their doctors about the possible risks and benefits of erythropoiesis-stimulating agents (ESAs) to manage anemia during chemotherapy under a new program just approved by the FDA.

ESAs can be given to chemotherapy patients to reduce the need for blood transfusions.  However, there can be problems with ESAs including causing some tumors to grow faster or some patients to die sooner.  They can also increase risk for blood clots, heart failure, heart attack or stroke.

ESAs, including Procrit®, Epogen®, and Aranesp®, are now covered by a REMS or Risk Evaluation and Mitigation Strategy which requires that patient receive a Medication Guide from their health care providers that tells them how to safely use an ESA drug.

In addition, health care providers who use ESAs with their patients must be be actively enrolled in  the APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) Oncology program and receive training in their safe use.  Read the rest of this entry »

House Energy and Commerce Committee Chair, John Dingell (D-MI) and Oversight Subcommittee Chair, Bart Stupak (D-MI) sent letters to Johnson & Johnson, Merck, Schering-Plough and Pfizer asking them to stop using “misleading and deceptive” direct-to-consumer advertising.

Dingell in a statement said, “Marketing department leaders have failed to commit to reducing misleading and deceptive ads, so we’re now asking the CEOs to make this agreement.” Stupak said, “We intend to make certain that drug companies market their product properly in order to protect American consumers from manipulative commercials designed to mislead and deceive for profit.”

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The House Energy & Commerce Subcommittee on Oversight convened a hearing May 8th to address Direct to Consumer (DTC) drug advertising by Johnson and Johnson, Pfizer and Merck Schering-Plough. C3 first raised questions in summer 2007 about Procrit® DTC advertising that ran from 1998 to 2005. Procrit is an anemia drug sold by Ortho Biotech, a subsidiary of Johnson and Johnson.

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