Contact us for free information or to start a free case review.
The Food and Drug Administration said that the label on a Johnson & Johnson drug administered to treat bladder conditions should have warnings about the drug's potential to cause agitation or hallucinations in children.
The Proposed Label Change
The drug is Ditropan, known generically as oxybutynin. The FDA proposes to update the warning label to note that the hallucinations and agitation as a result of the drug's use were most common among children.
The current label does discuss the drug's potential to cause central nervous system side effects such as nervousness, confusion, convulsion and hallucination, but it doesn't specify that children are the ones most likely to experience it.
The proposed label would also tell doctors to monitor patients taking the drug for these side effects.
A meeting of a panel of medical experts was scheduled to discuss the issue today.
Johnson and Johnson spokesperson, Gloria Vanderham, said that the company plans to update the label.
The Drug Review
A review of the drug by the FDA found that it had a higher rate of central nervous system events in children than adults.
It looked at 202 reports (37 in children) of central nervous system side effects and found that hallucination was the most common one in children.
Hallucinations accounted for 27 percent of the reported events in children aged 17 and younger, while they accounted for only 11 percent of events in adults between the ages of 17 and 59.
Elderly people displayed similar rates of hallucination. Of the reported central nervous system events in patients aged 60 and older, 25 percent were hallucinations.
Harmed by a dangerous drug? If you or a loved one has been seriously injured or killed as a result of using a dangerous or defective drug, you may be able to recover compensation for your losses, including pain, suffering, missed work, medical expenses and more. Please contact us today for a free consultation with an experienced product liability attorney who can help you plan the appropriate recourse.
Copyright © 2001 - 2012 Online Lawyer Source
ATTORNEY ADVERTISEMENT—Thank you for your visit. The content published on this website was not written by medical professionals and should not, at any point, be mistaken for medical advice. Furthermore, the information on this site is intended for educational purposes only and should never interfere with a patient/site visitor and his or her healthcare provider. In addition, viewing the content on this website, requesting additional information, or transmitting information through a contact form should never be considered the formation of an attorney-client relationship. The material published on this site is general and may not apply to your specific circumstances. Every case comes with its own set of unique circumstances; past success discussed on this site does not guarantee future performance. Information found on this website should not be used as incentive to act without seeking counsel from a professional. For more information, please read our disclaimer.