Yourlawyer.com (Ditropan News) http://www.yourlawyer.com/topics/overview/ditropan Sat, 21 Nov 2009 22:57:32 -0800 pixel-app en FDA: Bolster warning on bladder drug http://www.yourlawyer.com/articles/read/12749 Tue, 10 Apr 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12749
The drug, also known as oxybuty nin, already lists insomnia, nervous ness, confusion and other central nervous system risks on its label, but staff reviewers said more expli cit cautions are needed.

Specifically, labeling should point out that the drug can cause such problems and the risks have been reported in patients taking the drug. It should also call on doctors to monitor for symptoms, they wrote in a memo last month.

The staff reviewed 202 reports of central nervous system side effects in Ditropan patients -- 37 in those 17 and younger and 143 in adults; no age was reported in 22 cases. Those 202 reports mentioned hallucinations in 27 percent of the pediatric cases and in 25 percent of those aged 60 and older. Hallucinations were reported in 11 percent of cases for adults aged 17 to 59.

The documents were released ahead of an FDA advisory panel meeting scheduled for tomorrow to review use of Ditropan and several other drugs in children.]]> Ditropan Hallucinations Side Effects Injury Lawyer http://www.yourlawyer.com/topics/overview/ditropan Tue, 10 Apr 2007 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/ditropan Ditropan Has Been Linked to Hallucinations

On April 9, 2007, the FDA released documents stating the Johnson & Johnson’s drug Ditropan for overactive bladders needs stronger warnings about the threat of hallucinations and other related problems in children and older patients. The Food & Drug Administration originally approved Ditropan (generic: Oybutynin) in June 1999.

To date, the label for Ditropan already lists insomnia, nervousness, confusion and other central nervous system risks, but staff reviewers said more explicit cautions are needed. The FDA’s gatherings state that, the labeling for Ditropan should point out that the drug can cause such problems and that the risks have been reported in patients taking the drug. It should furthermore call on doctors to monitor for symptoms, they wrote in a memo dated March 2007.

An FDA team evaluated 202 reports of central nervous system side effects in Ditropan patients; 37 in those 17 and younger and 143 in adults; no age was reported in 22 cases. Of those 202 reports mentioned hallucinations in 27% of the pediatric cases and in 25% of those aged 60 and older. Hallucinations were reported in 11% of cases for adults aged 17 to 59.

If you or a loved one has taken Ditropan and experienced hallucinations or related side effects, please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney. Alternatively, call 1-800-LAW-INFO (1-800-529-4636).

]]>