Posted by Leo on March 29, 2001, at 8:43:32
In reply to Anyone had success on Effexor XR? , posted by jp on October 24, 1999, at 14:59:14
IF YOU'RE ANGRY NOW..........WAIT UNTIL YOU READ THE INFORMATION......SUPPLIED BY THE FDA..... IN THE FOLLOWING. ANYTIME THE FDA HAS TO "FORCE" THE MANUFACTURER TO COME CLEAN, THERE IS A HUGE DEGREE OF UNDERLYING PROBLEMS. THIS IS JUST THE BEGINNING.................MORE TO COME
The text below is taken from the drug data sheet for Effexor XR (Venlafaxine HCI) which was approved in it's new form by the FDA on 12 July 2000. A full copy of the 20 page document in Adobe Acrobat format can be downloaded by clicking the link at the end of this page.
The first section, relating to the short term premarketing trials, confirms the link between the drug and many of the side effects which I have mentioned on this web site (and many of which are the symptoms of serotonin syndrome) including; amnesia, confusion, depersonalization, hallucinations, paranoia, gastrointestinal problems, increased depression and vision impairment.
The second section confirms that postmarketing reports have suggested links with serotonin syndrome, neuroleptic malignant syndrome-like events, involuntary body movements and shock-like electrical sensations subsequent to discontinuation or tapering of the dose.
Having regard to the Safety Related Drug Labelling changes forced by the FDA in March 2000, which confirmed the existence of a severe dose and time related withdrawal syndrome, I believe that everything that I have said about this drug has been proven; that patient's prescribed Venlafaxine are at risk of developing severe and potentially fatal side effects to the drug and that in many cases such patients are unable to discontinue the drug or taper withdrawal. Nevertheless I'm convinced that there is lots more to come.
The question which begs to be asked is, why weren't we warned!EFFEXOR & EFFEXOR XR (venlafaxine HCl) Tablets
[March 3, 2000: Wyeth-Ayerst]
DRUG ABUSE AND DEPENDENCE:
Physical and Psychological Dependence: New third paragraph -
"Discontinuation effects have been reported in patients receiving venlafaxine (see DOSAGE AND ADMINISTRATION)."
DOSAGE AND ADMINISTRATION:
Discontinuing Effexor (venlafaxine HCl): First sentence revised (new text in italics) -
"When discontinuing Effexor after more than 1 week of therapy, it is generally recommended that the dose be tapered to minimize the risk of discontinuation symptoms. Patients who have received Effexor for more than 6 weeks or more should have their dose tapered gradually over at least a 2-week period."
New second paragraph -
"Discontinuation symptoms have been systematically evaluated in patients taking venlafaxine, to include prospective analyses of clinical trials in Generalized Anxiety Disorder and retrospective surveys of trials in depression. Abrupt discontinuation or dose reduction of venlafaxine at various doses has been found to be associated with the appearance of new symptoms, the frequency of which increased with increased dose level and with longer duration of treatment. Reported symptoms include agitation, anorexia, anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth, dysphoric mood, fasciculation, fatigue, headaches, hypomania, insomnia, nausea, nervousness, nightmares, sensory disturbances (including shock-like electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting. It is therefore recommended that the dosage of Effexor be tapered gradually and the patient monitored. The period required for tapering may depend on the dose, duration of therapy and the individual patient. Discontinuation effects are well known to occur with antidepressants."
Discontinuing Effexor XR:
"When discontinuing Effexor XR after more than 1 week of therapy, it is generally recommended that the dose be tapered to minimize the risk of discontinuation symptoms. In clinical trials with Effexor XR, tapering was achieved by reducing the daily dose by 75 mg at one week intervals. Individualization of tapering may be necessary. [The remainder of the paragraph beginning with "While the discontinuation effects of Effexor XR have not been systematically evaluated in controlled clinical trials, retrospective..." has been deleted] and replaced with -
"Discontinuation symptoms have been systematically evaluated in patients taking venlafaxine, to include prospective analyses of clinical trials in Generalized Anxiety Disorder and retrospective surveys of trials in depression. Abrupt discontinuation or dose reduction of venlafaxine at various doses has been found to be associated with the appearance of new symptoms, the frequency of which increased with increased dose level and with longer duration of treatment. Reported symptoms include agitation, anorexia, anxiety, confusion, coordination impaired, diarrhea, dizziness, dry mouth, dysphoric mood, fasciculation, fatigue, headaches, hypomania, insomnia, nausea, nervousness, nightmares, sensory disturbances (including shock-like electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting. It is therefore recommended that the dosage of Effexor XR be tapered gradually and the patient monitored.
poster:Leo
thread:13781
URL: http://www.dr-bob.org/babble/20010327/msgs/57897.html