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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 9 of 9. This is the beginning of the thread.
Posted by Phillipa on April 25, 2018, at 19:17:17
Add to Email Alerts
The anticonvulsant medication lamotrigine can cause the rare but serious immune system reaction hemophagocytic lymphohistiocytosis (HLH), the US and Food and Drug Administration said today in a safety communication.The FDA said a warning about the risk for HLH will be added to the prescribing information on lamotrigine drug labels.
Lamotrigine is used alone or with other medicines to treat seizures in patients age 2 years and older. It is also indicated for maintenance treatment in patients with bipolar disorder to help stave off mood episodes (depression, mania or hypomania, and mixed episodes).
HLH is a hyperinflammatory syndrome that can lead to hospitalization and death, especially if not diagnosed and treated quickly. Diagnosis is often complicated because early signs and symptoms, such as fever and rash, are not specific, the FDA notes. HLH may also be confused with other serious immune-related adverse reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).
Lamotrigine was approved in 1994 and is available under the brand name Lamictal (GlaxoSmithKline) and in generic forms. In the 24 years since approval, the FDA has identified eight cases (two in the United States and six abroad) of confirmed or suspected HLH associated with lamotrigine in children and adults but says there are "likely additional cases" that they are unaware of.
There is "reasonable evidence" that lamotrigine was the cause of HLH in these eight cases, based on the timing of events and the order in which they occurred, the agency said. All eight patients required hospitalization and received drug and other medical treatments. One patient died.
The FDA recommends that patients taking lamotrigine who develop fever or rash be evaluated promptly; the drug should be stopped if HLH or another serious immune-related adverse reaction is suspected and an alternative cause for the signs and symptoms cannot be established.
Patients receiving lamotrigine should be advised to seek immediate medical attention if they experience symptoms of HLH. HLH can be diagnosed if a patient has at least five of the following eight signs or symptoms:
Fever and rash;
Enlarged spleen;
Cytopenias;
Elevated levels of triglycerides or low blood levels of fibrinogen;
High levels of blood ferritin;
Hemophagocytosis identified through bone marrow, spleen, or lymph node biopsy;
Decreased or absent natural killer cell activity; and
Elevated blood levels of CD25 showing prolonged immune cell activation.
Healthcare professionals are encouraged to report adverse events related to use of lamotrigine to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Posted by Phillipa on April 25, 2018, at 19:19:31
In reply to FDA alert on Lamictal just issued Rare Autoimmune, posted by Phillipa on April 25, 2018, at 19:17:17
Just received this Alert in my e-mails. Not even googleable yet. Phillipa
Posted by Phillipa on April 26, 2018, at 17:44:02
In reply to Re: FDA alert on Lamictal just issued Rare Autoimmune, posted by Phillipa on April 25, 2018, at 19:19:31
Google FDA update available now. Phillipa
Posted by ed_uk2010 on April 28, 2018, at 9:47:33
In reply to FDA alert on Lamictal just issued Rare Autoimmune, posted by Phillipa on April 25, 2018, at 19:17:17
That's interesting. Thanks Phillipa.
Posted by Phillipa on April 28, 2018, at 11:32:06
In reply to Re: FDA alert on Lamictal just issued Rare Autoimmune, posted by ed_uk2010 on April 28, 2018, at 9:47:33
Ed you're welcome. PJ
Posted by Jeroen on May 7, 2018, at 16:03:34
In reply to FDA alert on Lamictal just issued Rare Autoimmune, posted by Phillipa on April 25, 2018, at 19:17:17
this lamictal almost killed me i ended up in emergency room in 200X, abilify got me out of this mess, police brought me to emergency room in 200X stay away from this evil medicine
rash, psychosis, immune disease, seizures, death!
Posted by Lamdage22 on June 1, 2018, at 12:11:42
In reply to this lamictal almost killed me i ended up in emerg, posted by Jeroen on May 7, 2018, at 16:03:34
> this lamictal almost killed me i ended up in emergency room in 200X, abilify got me out of this mess, police brought me to emergency room in 200X stay away from this evil medicine
>
> rash, psychosis, immune disease, seizures, death!Oh wow. Sorry you had to go through this!
Posted by Jeroen on June 1, 2018, at 12:22:46
In reply to Re: this lamictal almost killed me i ended up in emerg, posted by Lamdage22 on June 1, 2018, at 12:11:42
thanks for your tap on my shoulder Lamdage22
Posted by Lamdage22 on June 1, 2018, at 12:39:38
In reply to Re: this lamictal almost killed me i ended up in emerg, posted by Jeroen on June 1, 2018, at 12:22:46
Nardil made me psychotic. But i am no longer angry. Its the past
This is the end of the thread.
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