Re: Warning on Propulsid and the FDA

From: Karla Nygren (ifirgit@up.net)
Tue Jan 25 23:59:53 2000


Believe me Karen....I have virtually no faith in the FDA....yet alone blind faith. I still firmly believe that they were very negligent in the approval of fenphen. Having worked for the federal government I have little faith in any government agency.

Thanks for making me feel welcome!

Karla

DA is watching out for everyone, but don't place >blind faith in them.
>They have a very hard job, and medicine is still pretty primitive when you
>think about it - how long has it been since the local barber did surgery
and >doctors used leeches?
>
>Recent articles in the New York Times have included the following:
>FDA concern over the barrage of advertisements for prescription drugs -
they >also watch for side effects AFTER a drug is introduced (which seems to be
>what happened with Propulsid). Their concern now is, with the TV ads
sending >people to the doctor asking for a drug they saw advertised, the initial
>usage will be much higher and more widespread than before ads were allowed,
>creating situations where the "other side effects" do much more harm, and
>faster. Of course, it's good that the ads have to include warnings of
known >side effects.
>
>Also, there was an article about the apparent poor statistical validity of
>many clinical trials, which is why some side effects don't show up until
>after approval.
>
>And, there is increasing pressure from patients who want the actual drug in
>clinical trials instead of a placebo, making it more difficult to field
>trials.
>Combine that with the recent article on how placebos seem to work just as
>well as the treatment, and it makes you want to find a Chinese herbalist
>with 3000 years of "trials" as backup!
>
>I now ask for the Rx insert to study the known side effects of a drug
BEFORE >I take anything. When my PCP prescribed Axid, he gave me a two-week trial
>kit with good info. I still was reluctant to take it for a couple of weeks.
>It seemed to help more than the candied ginger (ginger is the best herbal
>remedy for nausea and heartburn, and also has a beneficial effect on female
>reproductive system - you can make ginger tea with powdered ginger and hot
>water that works better than any tea-bag ginger tea). (I've had so many
bad >side effects from drugs, that I try herbal remedies first.)
>
>When I tried to fill the Rx, USHC told the pharmacist that I had to try
>Tagamet or another drug first - I researched all three on
>http://www.medicinenet.com (very accessible, good Rx info although they still
don't >have an entry for adhesions in the disease section). Found the two USHC
was >recommending were for ulcers more than GERD, and had more side effects that
>would have been bad for me. So I told that to the nurse who had to call
>USHC to get approval for Axid, and that I had already tried over the
counter >for 3 months, so they approved it.
>
>By the way, my first stomach problem was last May 1 - it felt like the baby
>Alien (you had to see the movie) was trying to poke through my stomach. I
>used candied ginger after every meal for two months and it healed
>completely. If it wasn't for the post-op Motrin on Aug 12, I think my
>stomach would now be ok. The strange part is that I now think the baby
>alien spasms were adhesions. I had endo spread to my stomach back in the
>80's, and wonder if I have adhesions from that inside my stomach. I hate
>to contradict Bev, but I do think adhesions can form well after the first
>few days after surgery, or at least existing adhesions can get worse.
>I always feel some sort of internal spasm that later reveals itself as
>adhesions. My first "back spasm" in 1987 was like that. I felt a flutter
>inside just before the spasm started. That was two years after my first
>laparatomy.
>
>Take care all, and glad you are with us, Karla.
>Karen
>

>>----- Original Message -----
>From: Karla J Nygren <ifirgit@up.net>
>To: Multiple recipients of list ADHESIONS <adhesions@forum.obgyn.net>
>Sent: Tuesday, January 25, 2000 1:56 PM
>Subject: Re: Warning on Propulsid
>
>> Wow! Thank you Karen! It is so critical to know of all of these
problems >> before we take the drugs. I have already dealt with one drug
>> problem.....phenfen. I don't need to take on another. Thank you Bev for
>> catching that. The FDA is working for us....trying to make sure that
>these
>> drugs are totally safe for us to take.....we shouldn't want them to do
>> anything else....in fact after the phenfen issue we should demand that
the >> FDA follows very strict guidelines in giving approval.
>>
>> Karla

>>> ----- Original Message -----
>> From: Bernie and Beverly Doucette <bnb@cybrzn.com>
>> To: Multiple recipients of list ADHESIONS <adhesions@forum.obgyn.net>
>> Sent: Tuesday, January 25, 2000 9:42 AM
>> Subject: Re: Warning on Propulsid
>>
>> > Man....what a scare! I just mentioed this to a fellow ARD memeber who
>> DOES
>> > have a heart problem and is about to receive a prescription TODAY for
>> GERD!!
>> >
>> > Now can people understand just why it may have been in our best
interest >> NOT
>> > to have had the Intergel appproved by the FDA?? Better to be safe then
>> sorry
>> > and I sure don't want to have to know the first fatality in the event
>> > something isn't ready to be be approved...let the experiments stay in
>the
>> > research labs and not get out until things are ready to be used safely
>on
>> > those who need them!
>> >
>> > If any of you still harbored any feelings against the FDA for not
>> approving
>> > the Intergel...may those feelings be laid to rest with this
>announcement!
>> >
>> > Thank-you Karen
>> >

>>> > ----- Original Message -----
>> > From: Karen Kaplan <kkaplan@eclipse.net>
>> > To: Multiple recipients of list ADHESIONS <adhesions@forum.obgyn.net>
>> > Sent: Tuesday, January 25, 2000 8:20 AM
>> > Subject: Warning on Propulsid
>> >
>> > >
>> > > The FDA announced yesterday that Propulsid can cause dangerous
>irregular
>> > > heartbeats and even sudden death.
>> > > So, those of you with GERD, try something else - my PCP has me on
>Axid,
>> > > which has very few side effects and is specifically for GERD.
>> > > I also find candied ginger very helpful - the Axid is to repair the
>> damage
>> > > to my stomach from Motrin last August.
>> > > Karen
>> > >
>> > > to the unsubscribe form at
>http://www.adhesions.org/forums/listcmds.htm
>> >

http://www.adhesions.org/forums/listcmds.htm >> >
>>
>


Enter keywords:
Returns per screen: Require all keywords: