Larry Lewis said:Is there anyone out there currently relying on Serdolekt who might be willing to share their honest take on the drug? I’m looking for some actual insight—not just the glossy brochure version—regarding how it actually feels to use it.
USAAbbott Labs First applied for U. S. food and drug Administration approval for sertindole back in 1996,[1] but
they ended up pulling the plug on that application in 1998—mostly due to worries regarding an increased risk of sudden death caused by QTc prolongation.[2] To give you an idea of the scale, in one trial involving 2,000 patients, 27 people passed away unexpectedly, which included 13 sudden deaths.
Europe in EuropeOver in Europe in Europe, the drug was actually approved and sold in 19 different countries starting in 1996,[3] but
its authorization was suspended by the Food and Drug Administration in 1998[7], leading to it being pulled from the market entirely. Fast forward to 2002: after looking at fresh data, the FDA's advisory committee suggested that Sertindole could be reintroduced for restricted Use in clinical trials , with strong safeguards including extensive contraindications and warnings for patients AT risk of cardiac dysrhythmias, along with dropping the max dose from 24 mg to 20 mg (unless there's a really good reason not to) and requiring strict ECG monitoring both before and during treatment.[8][9] Eventually, the marketing ban was lifted in 2005.[10]
http://en.wikipedia.org/wiki/Sertindole 😲
http://www.facebook.com/topic.php?ui...88&topic=14057 😲
The maker of the antipsychotic med sertindole (Serdolect) chose to voluntarily stop making it available.
This move came down to serious concerns regarding reports of heart arrhythmias and sudden cardiac death linked to its use.(Reference: (GBRCW) Communication, 02 Dec 1998)
Safety and serious adverse events
Out of the 97 serious adverse events recorded, 10 were fatal. This included 2 suicides, 3 sudden deaths (specifically 2 heart attacks and 1 pulmonary embolism), 4 "other" deaths (one pulmonary embolism, one unspecified intoxication, one heart attack, and one mesenteric artery infarction), plus 1 death where the cause couldn't be determined.