Report Problems with
Prescription Drugs
Healthlink on Air (05/11/08)
... from
the Every Patient's
Advocate Tip of the Week...
In the past several years, we’ve heard news
reports of a number of drugs that have been pulled from the market. Why? There
are a couple of reasons – and they are important so we can learn about taking
new drugs ourselves.
You’ve heard of Vioxx – you may have taken Vioxx – Vioxx was approved by the FDA
in 1999, and became practically an overnight success for treating pain. Within
the next few years, some patients who had previous heart problems began to get
sicker, some even died after taking Vioxx. Since then, Merck, the manufacturer,
lost a multi billion dollar lawsuit lost a 4.85 billion dollar lawsuit and now
hundreds of thousands of people will collect a piece of that. Why? because it
turns out they knew about the problems with those drugs, and withheld that
information when they applied for approval from the FDA.
Another example of why drugs are pulled from the market is the case of Zelnorm a
drug used to relieve gastrointestinal problems. It was approved in 2002 to
relieve gastrointestinal problems and then removed from the market in early 2007
because patients began showing symptoms of heart problems. In this case, it was
pulled from shelves because wasn’t that the manufacturer, Novartis, had hidden
anything from the FDA; rather, it was the fact that doctors began reporting that
their patients suffered the negative side effects….
An this week we learned that Singulair, a drug used for asthma has been
questioned because suicides have been reported…
You may have even heard this week about FDA hearings on Singulair. Many people
have reported problems with behavioral side effects as they have taken Singulair
for asthma. Families have reported that teenagers have committed suicide after
using singulair.
The bottom line is that it’s the patients and families making these reports –
and that’s today’s tip…
The bottom line is that it’s up to us patients and families to make sure our
doctors and the FDA know about problems with drugs --
Since we patients are the ones who take these drugs that newly come on the
market, it’s up to us to let our doctors – and the FDA – know about problems
with them. If drugs are dangerous, or create more problems than they solve…. We
need to step up to the plate to report them to make sure others we, and others,
aren’t harmed by them.
Now, let’s make sure we’re distinguishing drugs here. When your doctor
prescribes a drug that’s new to you, it may or may not be a new drug to the
market –
You can get a sense of how long that drug has been on the market from your
doctor. Just ask! If the drug has been around for more than 5 or 6 years, then
it’s reasonable to expect that the side effects and contra indications have been
well documented and are public. You can look them up and learn about your drug.
However, If your doctor indicates the drug is relatively new – fewer than 5 or 6
years on the market, then it could be that not all side effects or contra
indications have been made public…. That’s when we patients need to let our
doctors, and the FDA, know about them.
So, if you are given a relatively new drug, and you begin to experience any
unusual – to you – side effects or something just doesn’t feel right to you,
then here’s what you’ll need to do:
Write down exactly what it feels like, when you feel it, and under what
circumstances…. So for example, if you take a pill and a bit later you feel
woozy or lightheaded, or your stomach gets upset – whatever it is, record the
time you took the pill, exactly what your experienced side effect was and maybe
what food you ate just before or just after. After you’ve experienced that side
effect a few times, then contact your doctor’s office.
If it has already been well documented, then your doctor may already know about
it. And it will give you an opportunity to review whether it’s exactly the right
drug for you.
Your doctor may or may not report your problems to the FDA – sometimes it
depends on how busy he is – regardless, you should report the
In addition to your
doctor, take the time to report
your problems to the FDA through
their MedWatch program. You can
do that by calling a phone
number, 1-888-INFO-FDA
(1-888-463-6332) or by accessing
the FDA’s website at fda.gov/medwatch,
where you’ll find a form to fill
out. This reporting structure is
called Medwatch – and it’s an
excellent way the FDA can track
potential problems with drugs.
Don’t get me started on why the FDA doesn’t do a better job of vetting these new
drugs before they are approved! That would take weeks worth of tips! But in the
meantime, it’s great to know that we patients do have tools for reporting
problems and perhaps preventing problems for others as well.
Are you
interested in more tips?
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Trisha Torrey is Every Patient’s
AdvocateTM.
She offers no medical advice,
but empowers those who
want to learn more about
diagnosis and treatment options
by
providing useful tools and
resources.
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