[IP] Inhaled Insulin Gets Lung Cancer Warning
April 9, 2008 Updated labeling for insulin human (rDNA origin) inhalation
powder now warns smokers regarding a potential risk for lung cancer, the US Food
and Drug Administration (FDA) warned today. The product is marketed as Exubera
by Pfizer under license from Nektar Therapeutics. The product is marketed as
Exubera under license from Nektar Therapeutics.
Data from the company's clinical trial program have revealed that 6 of 4740
patients taking inhaled insulin developed lung cancer compared with 1 of 4292
patients who received an active comparator (incidence, per 100 patient years
exposure, 0.13 vs 0.02). Postmarketing reports also identified 1 case of lung
All patients who were diagnosed with lung cancer had a prior history of
cigarette smoking, according to an alert issued by MedWatch, the FDA's safety
information and adverse event reporting program. However, the data were
insufficient to establish a causal role for the product.
Pfizer previously announced that it would cease marketing the product because
it did not meet either consumer needs or the company's financial expectation.
Today's announcement coincides with that of Nektar Therapeutics stating that it
has terminated all negotiations with potential partners for inhaled insulin.
"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 Joe Feczko, MD, Pfizer's chief
Insulin inhalation powder is indicated to improve glycemic control in adult
patients with diabetes mellitus.
Adverse events associated with use of inhaled insulin should be reported to the
FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at
1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600
Fishers Lane, Rockville, MD 20852-9787
http://tinyurl.com/5u7lmb - Will need a medscape acct to view.
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