Pfizer Inc has updated the US product labelling for Exubera (insulin human [rDNA original]) inhalation powder to include a warning with safety information about lung cancer cases observed in patients who used Exubera.
The update is based on an ongoing review of the data from the Exubera clinical trial programme and post-marketing experience by Pfizer and the Food and Drug Administration (FDA). Since the inception of the programme, Pfizer has continuously monitored respiratory safety. Over the course of the clinical trial programme, 6 of the 4,740 Exubera-treated patients versus 1 of the 4,292 patients not treated with Exubera developed lung cancer. In addition there was a post-marketing report of lung cancer in one Exubera-treated patient. The update to the labelling states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the development of lung cancer is related to the use of Exubera.
"Pfizer is vigilant in monitoring adverse drug reports for all its products, including Exubera, which has shown in clinical trials to be a safe and effective medicine in the treatment of adults with type 1 or type 2 diabetes," said, Joe Feczko, chief medical officer, Pfizer.
Pfizer announced in October 2007 that it would stop marketing Exubera because it did not meet customers' needs or the company's financial expectations. Nektar Therapeutics has also stopped its search for a new marketing partner. Pfizer would be discussing the timing of marketing authorisation withdrawals with regulatory agencies.
"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies. Physicians should seek alternate treatment options to maintain patients' glycemic control," said Dr. Feczko.
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