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
> >
>