My sweet Lamictal
Looks like Glaxo is having some trouble getting a patent for its extended release version of Lamictal, an anti-seizure med that I use (off-label?) as a mood stabilizer. From Reuters (belatedly):
NEW YORK, Sept 21 (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) said on Friday that U.S. health regulators stopped short of approving a new long-acting version of its widely used epilepsy drug, Lamictal, until certain concerns are addressed.Europe's largest drugmaker, which received a so-called approvable letter regrading its Lamictal XR, said it is committed to working with the U.S. Food and Drug Administration to address any questions the agency has and to evaluate the best way forward to outright approval.
The company did not specify what FDA questions or concerns must be addressed in order to gain approval.
Lamictal XR is a once daily extended-release formulation of the older medicine, which is taken twice daily by most epilepsy patients. The older version, which had nearly $2 billion in sales last year, is already facing competition from cheap generic versions in Europe and generic competition in the United States could come as soon as next year. (Reporting by Bill Berkrot)
I know Lamictal can have dangerous side effects upon initial treatment; maybe those are intensified with the long-acting version. I've been taking it for years -- knock wood -- with excellent results.
[Image from The Chem Blog]
Comments
“I know Lamictal can have dangerous side effects upon initial treatment; maybe those are intensified with the long-acting version. I've been taking it for years -- knock wood -- with excellent results.” --- Liz Spikol
Now just imagine if those patients who did experience the “dangerous side effects” of this drug and their support people decided to request the banning of this medication. It is similar to groups that want to see ECT banned even though there are other patients who benefit.
Just imagine where you would be if other patients were successful in banning Lamictal from which they had serious side effects.
I can assure you I read similar advocacies for banning numerous medications. Imagine if I had lobbied and successfully campaigned to ban Lamictal because of my spouse’s serious and life threatening side effects from the drug; how happy you’d be now.
The point is I have an understanding that all medications should be properly tested and certified for reasonable safety and efficacy and any patient taking any medication or therapy should be reasonably educated to make informed decisions in collaboration with an attending physician and weigh the benefits against the risks.
From my personal experiences as a support person I’m well aware there is a price to pay whether short-term or down the line from the use of any psychotropic medications. The fact that my spouse encountered serious side effects from Lamictal does not cloud or anger my feelings toward the medication knowing full well that others are more fortunate and are benefiting from the same medication.
What properly have to be addressed are the shortcomings and improprieties on the part of the sponsors of these various therapies to fudge test results and/or promote off label use without proper testing in my opinion.
Warmly
Herb
VNSdepression.com
Posted by: Herb | October 8, 2007 08:02 PM
Herb, I couldn't have said it better myself. We each come from a unique genetic pool, have one-of-a-kind brain chemistry and our life experiences and environment are so personal. A treatment that reeks havoc on one person can be a miracle for another. Like Liz, Lamictal has been a godsend for my daughter. Of course, we need to be cautious about big Pharma and there are some awful and tragic stories out there. Thank you for your balanced viewpoint and for your open-mindedness.
Posted by: Helen | October 11, 2007 11:47 PM
Liz:
Lamictal is now officially FDA-approved for maintenance treatment of bipolar disorder.
Posted by: Larry Parker | October 13, 2007 02:58 AM