Lotronex™ led to at least four deaths and nearly 200 cases of severe intestinal complications before being withdrawn from the market after only eight months. Such frightening statistics are exactly why so many physicians and patients were stunned by the selective re-release of Lotronex™ in June of 2002.

Lotronex™ was initially introduced to women suffering from irritable bowel syndrome (IBS), a painful condition affecting an estimated 10-20% of the general population. IBS is one of the most frequently diagnosed disorders found by primary care physicians. Also called spastic colon, symptoms of IBS include lower abdominal pain and irregular bowel habits. Irritable bowel syndrome does not require surgery, but can be incredibly frustrating and painful, and IBS patients often seek treatment in the form of prescription medications.

Surprisingly, in June of 2002, GlaxoSmithKline submitted an appeal to the FDA to allow prescription of Lotronex™ to a select group of patients whose IBS is considered debilitating. Thus, a landmark re-release of a withdrawn medication took place, and Lotronex™ was actually approved for prescription under limited distribution. A stringent screening process is necessary to obtain a prescription to Lotronex™, but if a woman can prove her IBS is exceptionally severe she may obtain a Lotronex™ prescription. A physician-patient agreement must be signed before a woman begins treatment with Lotronex™.

While it is claimed that some cases of IBS are debilitating enough to justify endangering women’s gastrointestinal health to the extent seen in Lotronex™ use, many doctors do not agree. Even more questionable is the fact that GlaxoSmithKline heads the risk management program for Lotronex™ users. Many wonder how those profiting from robust Lotronex™ sales can truly provide an objective safety assessment. Read more about Lotronex™: http://www.fda.gov/cder/drug/infopage/lotronex/lotronex-qa.htm
http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm

If you or a loved one took Lotronex™ to manage IBS and suffered from health complications, contact our Philadelphia Lotronex™ lawyers today. Lotronex™ victims and their families should not have to bear the burden of medical bills alone. Our attorneys will review your Philadelphia area Lotronex™ case and assess your history with the drug to determine the proper path for you.