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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by SLS on April 22, 2005, at 11:43:02
From Medscape:
Trileptal May Cause Serious Dermatologic Reactions
April 20, 2005 — The U.S. Food and Drug Administration (FDA) and Novartis Pharmaceuticals Corp have warned healthcare professionals of the risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) associated with use of oxcarbazepine (Trileptal) in adults and children, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program. A limited number of multi-organ hypersensitivity reactions have also been reported.Oxcarbazepine tablets and oral suspension are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and in children aged four to 16 years.
The FDA has received reports of serious and potentially life-threatening dermatologic reactions, including SJS and TEN, in adult and pediatric patients receiving oxcarbazepine. Median time of onset was 19 days and some patients required hospitalization; fatal outcomes were rare.
The FDA notes that the reported incidence of SJS and TEN, which is generally considered an underestimate due to underreporting, exceeds the background incidence rate estimate (0.5 - 6.0 cases/million person-years) by a factor of 3- to 10-fold.
Replacement of oxcarbazepine with another antiepileptic medication should be considered in patients who develop a dermatologic reaction during treatment.
Multi-organ hypersensitivity reactions have also been reported after initiation of oxcarbazepine therapy in adult and pediatric patients, with a median time to detection of 13 days (range, 4 - 60 days). Although the number of reports is limited, many of these patients required hospitalization, some for life-threatening conditions.
Signs and symptoms were diverse due to the variable nature of disease expression, but patients typically presented with fever and rash associated with other organ system involvement. Manifestations included (but were not limited to) lymphadenopathy, hepatitis, liver function test abnormalities, hematologic abnormalities (eosinophilia, thrombocytopenia, neutropenia), pruritis, nephritis, oliguria, hepatorenal syndrome, arthralgia, and asthenia.
Replacement of oxcarbazepine with alternative therapy is recommended if multi-organ hypersensitivity is suspected. The FDA notes the possibility of cross-sensitivity to other drugs associated with this syndrome.
Posted by Phillipa on April 22, 2005, at 17:39:39
In reply to Trileptal May Cause Serious Dermatologic Reactions, posted by SLS on April 22, 2005, at 11:43:02
So I guess I was lucky when I changed pdocs and the new one dc'd the trileptal. I was only on l50mg. He had planned to titrate up as a sleep aid. Fondly, Phillipa
Posted by Minnie-Haha on April 22, 2005, at 18:27:45
In reply to Trileptal May Cause Serious Dermatologic Reactions, posted by SLS on April 22, 2005, at 11:43:02
I got off Depakote cause I gained 30 pounds on it. (I think it messed up my metabolism and periods, too, but that's another story.) I had to quit Lamictal cause I got a rash. Trileptal has worked pretty well for me and I've thought, "Well, at least no serious side effects." Sometimes I feel like I'm banging my head against the wall...
Oh well, I'll keep pushing on.
Posted by SLS on April 23, 2005, at 7:17:15
In reply to Re: Trileptal May Cause Serious Dermatologic Reactions, posted by Minnie-Haha on April 22, 2005, at 18:27:45
> I got off Depakote cause I gained 30 pounds on it. (I think it messed up my metabolism and periods, too, but that's another story.) I had to quit Lamictal cause I got a rash. Trileptal has worked pretty well for me and I've thought, "Well, at least no serious side effects." Sometimes I feel like I'm banging my head against the wall...
>
> Oh well, I'll keep pushing on.
I think the skin reactions described are very infrequent, and show up early in treatment. If you were going to get it, it would have showed up by now.I plan on giving Trileptal a try in the not-too-distant future if necessary. I wouldn't hesitate, despite this warning.
- Scott>
Posted by Minnie-Haha on April 23, 2005, at 13:11:21
In reply to Re: Trileptal May Cause Serious Dermatologic Reactions, posted by SLS on April 23, 2005, at 7:17:15
> I think the skin reactions described are very infrequent, and show up early in treatment. If you were going to get it, it would have showed up by now.
>
> I plan on giving Trileptal a try in the not-too-distant future if necessary. I wouldn't hesitate, despite this warning.Thanks for the reassurance. I hope your try on it goes well. The only advice my pdoc gave me was to make sure every third drink I take is something besides water (to help your serum sodium from going too low... which I think is only a real problem at higher doses).
This is the end of the thread.
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