5/24/2000 – Effexor – FDA Discontinuation Warnings

Thanks to Steve Whiting for alerting us to the following warnings from the
FDA. It is about time the gave us some warning about the terrible withdrawal
associated with the SSRI and SNRI antidepressants. I have highlighted a few
spots in this warning that I want you to take note of in particular.

Knowing HOW TO safely withdraw from serotonergic medications is one of the
most critical pieces of information patients need about these drugs –
information they are unfortunately not getting from their doctors. How one
withdraws can make the difference between life and death and can prevent the
long term debilitating effects that come from an abrupt or a much too rapid
withdrawal. Let me remind you once again that I have made an hour and a half
long audio tape to give patients and doctors withdrawal tips on safe and
successful withdrawal from these drugs as well as information on rebuilding
the body after their use. I could not longer find time to eat or sleep
because I was spending all of my time answering questions from doctors and
patients about safe withdrawal. A tape answering those questions seemed the
logical solution. The tape is inexpensive and very helpful. You can find
order information at

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org
________________________________

The FDA has forced safety related drug labeling changes regarding Effexor.

The changes acknowledge the existence of severe
discontinuation problems which are both dose and time
related and that the evidence of the problems has been
obtained from a retrospective survey of the clinical trials
database.

Steve Whiting
http://www.effexorfx.freeuk.com
__________________________

Please refer to
http://www.fda.gov/medwatch/safety/2000/mar00.htm#effexo

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 –

“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. I
t 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. The period required for tapering may
depend on the dose, duration of therapy and the individual patient. Discontinu
ation effects are well known to occur with antidepressants.”

Return to Quick Reference

699 total views, no views today

4/14/2000 – Safety Study Skimping?

This article appeared yesterday on the ABC News site. We know
that drugs are given only cursory tests before being introduced
into the marketplace. Pharmaceuticals counter that they do
extensive follow-up testing (post-marketing) to assure that the
drugs are in fact safe. Now, it appears that this is something to
which they only give lip service. Mark

http://abcnews.go.com/onair/WorldNewsTonight/wnt_000413_fd
a_feature.html

Report Says Drug Companies Fail to Complete Required Tests
When the Food and Drug Administration approves a drug it may
still have lingering questions about its safety or effectiveness
which it expects will be answered by the drug company.
(ABCNEWS.com)

By John McKenzie

N E W Y O R K, April 13 Evidence gathered by an
independent advocacy group suggests that many drug
companies in the United States are not keeping all of their
promises.

When a drug is approved by the Food and Drug Administration,
pharmaceutical firms are required to fulfill “post-marketing”
commitments to continue studying the safety and effectiveness
of the new product. Such research is necessary because the
FDA often approves drugs that have been tested on only a few
thousand people and lingering questions may remain about
how the drugs interact with other medicines or foods and what
kinds of side effects they may create in various patients.

The new study indicates, however, that many companies
routinely fail to follow through with these studies after the new
drugs reach the market. And the FDA is virtually powerless to do
anything about their lack of compliance.

The group that issued the report, Public Citizen, presented the
evidence to the FDA today, based on information obtained
through the Freedom of Information Act.

“Reliance on post-marketing studies as a way of safely
approving drugs is a dumb idea,” says Dr. Sidney Wolfe of Public
Citizen. “And a very dangerous idea because the studies mainly
are not getting done.”

Non-Compliance, No Consequences

According to Wolfe and the other authors of the report, FDA files
reveal that five drugs that were approved in the past decade and
later withdrawn from the market for safety reasons never had all
of their required follow-up studies completed.

And as of last December, only 11 out of the 88 new drugs that
were approved with post-marketing commitments between 1990
and 1994, had been subjected to the necessary studies or
properly filed the results. That€ ‘²s a compliance rate of just 13
percent.

“Five to ten years is certainly more than enough for the
overwhelming majority of these studies to be completed,” says
Dr. Brian Strom of the University of Pennsylvania. “The longer it
takes to answer these questions the longer patients are
exposed to potentially unnecessary risks.”

FDA Lacks Power

Representatives for the drug industry, however, say such studies
require greater patience.

“Specific studies that have to be designed, executed’. and if
they’re done in a comprehensive way they take a long time
to
do,” says Wayne Pines, a pharmaceutical industry spokesman.

But while the FDA can tell the drug companies to conduct
additional post-marketing studies, the fact is that once a drug is
on the market there’s little it can do to enforce the order.

Consumer advocates say Congress needs to give the FDA the
authority to impose fines on drug companies that break their
promises.

526 total views, no views today

09/07/1999 – Celexa & Alcohol

This is being remailed to make a minor correction. It comes from Dr.
Tracy and our ICFDA Director in Norway–

“I feel that this information coming in from our director in Norway is
so critical that it needs to get to all of you immediately. Hope you
can translate his English =-) Celexa has frightened me more than any
of these drugs since long before it was ever approved. We will be
hearing MUCH more about this extremely dangerous med. But if this is
happening with Celexa, the damage from the others being mixed with
alcohol is also there. How long will it take before anyone begins to
see this, who knows? The tragic twist to this is that these drugs
produce such an overwhelming craving for alcohol.” Ann
_________________________________

In Denmark the magazine: “Ugeskrift for Laeger” (a weekly magazine for
doctors) will publish a study that says that Celexa (citalopram,
Cipramil) can lead to death in combination with alcohol. They have
found that 4 users of celexa have died, and the obduction showed
normal doses of both Celexa and alcohol (0.8 per thousand) for some of
them. They say it’s to early to draw any conclutions, but the Danish
Legemiddelstyrelsen (the Danish FDA), are saying they will contact
other countries, and ask if they have noticed any of this problems. I
will try to pass along an abstract of this “obduction-study” when it
becomes available.

539 total views, no views today