The U.S. Food and Drug Administration staff released documents which indicate a risk of hallucination and similar problems in children and older patients. The drug Ditropan, known generically as oxybutynin, already lists a variety of other nervous system risks on its labeling, but more explicit cautions are needed.

Of 202 side effect reports in Ditropan patients, roughly 1/4 of younger than 18 and older than 59 patients reported these unlisted hallucination problems. The manufacturer, Johnson & Johnson, had no immediate comment.

Once again, great caution is urged before using any prescription drug that has not been in the marketplace for many years, since tests for side-effect safety of these new drugs are conducted unknowingly by consumers.

Source: FDA: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4295b1-index.htm