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'''Exubera''' is an inhalable insulin treatment for diabetes produced by [[Pfizer]]. [http://www.exubera.com/exubera/Active/content/index.jsp] It Was approved for use by the [[U.S. Food and Drug Administration]] in late January 2006. [http://www.fda.gov/bbs/topics/news/2006/NEW01304.html]
Announcing its approavla approval the FDA also stated that "Like any insulin product, low blood sugar is a side effect of Exubera and patients should carefully monitor their blood sugars regularly.Other side effects associated with Exubera therapy seen in clinical trials included cough, shortness of breath, sore throat, and dry mouth. Exubera is not to be used if you smoke or if you recently quit smoking (within the last 6 months). Exubera is not recommended in patients with asthma, bronchitis, or emphysema. Baseline tests for lung function are recommended after the first 6 months of treatment and every year thereafter, even if there are no pulmonary symptoms." [http://www.fda.gov/bbs/topics/news/2006/NEW01304.html]
Pfizer's media ket on the day of the announcement also included a [[video news release]] [http://xgen.vitalstream.com/mcasx.asx?media=1970281&package=1848098] produced by [[MultiVu]] [Pfizer's media ket on the day of the announcement also included a [[video news release]] produced by [[MultiVu]][http://www.prnewswire.com/broadcast/22903/consumer.shtml]
==Problems highlighted by the FDA==
:"FDA scientists who reviewed Exubera's new drug application identified a number of potential safety risks with the drug, including respiratory problems and hypoglycemia, but the advisory panel determined the health risks shouldn't prevent the product from being approved. For example, a large number of clinical trial participants reported experiencing cough when taking Exubera, but the panel found the severity of the coughing problems were generally mild." (Learner & Niven, 2005)
:"One panel member noted that Exubera's clinical data appear to show "a little bit of a signal of lung cancer risk," but she acknowledged the signs are faint and would require a large clinical study to confirm." (Learner & Niven, 2005)
:"Panel members did caution, however, that Pfizer and sanofi-aventis shouldn't overstate the convenience of the Exubera, which, in most cases, would decrease the number of a patient's injections but not eliminate injections altogether." (Learner & Niven, 2005)
==External links==
* Neal Learner & Michael Niven, Exubera's Benefits Outweigh Its Risks, Say FDA Advisers, ''Drug Industry Daily'', Vol. 4, No. 177, 9 September, 2005.
*U.S. Food and Drug Administration, "[http://www.fda.gov/bbs/topics/news/2006/NEW01304.html FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes]", Media Release, January 27, 2006.
*Pfizer, "[http://www.pfizer.com/pfizer/are/news_releases/2006pr/mn_2006_0127a.jsp Pfizer Receives FDA Approval for Exubera, the First Inhalable Form of Insulin for Controlling Type 1 and Type 2 Diabetes in Adults]", Media Release, January 27, 2006.
*Beth Herskovits, "[http://www.prweek.com/us/news/article/539477/ Pfizer selects WS for Exubera work]", ''PR Week'', February 2, 2006. (sub req'd).
[[Category:Health]][[Category:Pharmaceutical industry]][[Category:Fake News]]
