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Drug Safety and Availability

Editor's Note - Volume 1, Number 3, Spring 2008

In our third issue, an article on pemetrexed (Alimta), an antimetabolic antineoplastic agent, summarizes postmarket cases of radiation recall, an inflammatory reaction that may occur years after radiation exposure. Pemetrexed is the first drug to be approved for the treatment of malignant pleural mesothelioma (MPM), a rare type of cancer usually associated with a history of asbestos exposure. It is also approved as a second-line therapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).

We also describe the occurrence of serious liver injury in patients treated with the monoclonal antibody, natalizumab (Tysabri). This drug is indicated for the treatment of relapsing multiple sclerosis and moderate-to-severe Crohn's disease. Tysabri is also associated with other serious adverse events, including, but not limited to, anaphylaxis, opportunistic infections, and progressive multifocal leukoencephalopathy (PML). Patients receiving Tysabri for multiple sclerosis and Crohn's disease must be enrolled in a special restricted distribution program designed to help ensure the safe use of this product.

In the third article, we revisit carbamazepine (Carbatrol, Equetro, Tegretol, and generics) and the research and data behind the findings of increased risk of rare serious skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) for patients of Asian ancestry. As a follow-up to the feature article in the second issue of the Newsletter, it describes the role of pharmacogenomics in making a therapeutic and safety-based decision.

Finally, this Newsletter presents a brief description of FDA's Adverse Event Reporting System (AERS). The several hundred thousand adverse event and medication error reports FDA receives every year from manufacturers, healthcare professionals, and the public are vital in identifying postmarket drug safety issues. The summary statistics of the AERS data and information about access to the public data files are available at www.fda.gov/cder/aers/default.htm.

We would like to thank all who report adverse events to FDA and for their contribution to improve product safety and protect the public health. We value your comments. Let us know what you think of the Newsletter by contacting us at www.fda.gov/cder/comment.htm.

Renan A. Bonnel, PharmD, MPH
Senior Scientific Editor


Page created: June 12, 2008