Problem with a medicine or side effects? Report to the FDA!

susiestar

Roll With It
There is a way we patients can report problems with our medicine to the FDA.

It seems more and more of us see problems with what we take, or what our children take. If you are like me you have told the doctor and felt like the doctor really didn't treat it very seriously. I knwo when I was on Effexor the doctor acted like she had never heard of the problems I was having and she seemed truly STUNNED when I spoke of withdrawal from it. Other docs reacted similarly when I reported problems with celexa and many other similar medications.

So here is a link to report problems to teh FDA. The more we consumers let the FDA know what we are experiencing, the more warnings, and appropriate measures to treat side effects and withdrawal, will be created.

http://www.fda.gov/medWatch/report/consumer/consumer.htm

It isn't just up to the docs to report anymore. now WE have a way to report also!

While Jessie's reaction to elavil (amitryptyline) is certainly very rare, it is wellworth reporting. Even though this medication has been around a LONG time I am still reporting it. Because who knows if this has been happening in kids and no one knew?
 

Shari

IsItFridayYet?
Thanks, Susie.

Thanks to this website, I can go back and find several of wee difficult child's reactions and report those with accurate dates, too.
 

totoro

Mom? What's a difficult child?
You know I have always wondered about reporting it.
I never knew if they actually *listened* LOL

I never now if I am overreacting you know.
But like with Risperdal, the first 2 weeks she started taking it, she started having tics and movements. They continue to this day. Tongue thrust, hand movements, different things that come and go, but always something.
Same as most of us, when I have mentioned it to any of the doctor's. They have never seen this happen so quickly before so it could not be the Risperdal.

But she had never been on a medication prior to this and it started when she started the Risperdal.... hmm
They also said the, "Well the dose is to low"

So this would be a good one to report, I think?
I wonder if you can report things years after the fact?
I hate when Docs discount our thoughts, findings and fears.

Thanks Susie
 

susiestar

Roll With It
Totoro,

When in doubt, REPORT. Usually a mom's instincts, you know - that nagging feeling that just doesn't go away?- are right. Especially when it comes to something with our kids. We may be off when it comes to ourselves, but when it comes to the kids we are on target.

So report it, and if enough parents report things then there will be more warnings. Part of reporting's importance is that the studies done on medications are paid for by drug companies. Reactions, findings, etc. that do not support what the drug companies what to hear are hidden or ignored, sometimes even entire studies are buries. The researchers are bound by contracts to not tell anyone about it, even if the whole study is hidden and it is dangerous.

So if we parents find something, and can report it enough, we will have some say over the drug companies.

Just an example of what the drug co's can hide: There was a study that showed very clearly that amoxicillin does NOT treat ear infections. It was worse than a placebo. The drug co forced the doctor who did the research to NOT say anything. They wanted amoxicillin (the pink bubblegum antibiotic) to become the first drug that docs rx'd for ear infections. The study was buried and millions of doses of amoxicillin were given to kids.

Kids who had to suffer with ear infections (which are extremely painful in my opinion) for a full week to 2 weeks while taking a medication that clearly had been shown to NOT treat ear infections. So the bacteria in the body for other things learned all about how to become resistant to antibiotics and kids lost school time, parents lost work time, etc all so that the drug companies could make their $$$.

The researcher eventually broke his confidentiality and came forward to the press - the Wall Street Journal covered this whole thing - it RUINED the man's career and it was not covered as widely as it should have been because drug companies are very very powerful. Plus docs already had it in their heads that amoxicillin is the first medication you should give to a kid with an ear infection. So even now they give it to kids if parents don't argue against it.

THIS is why we parents need to report problems to the FDA directly!

Off my soapbox now!
 

susiestar

Roll With It
Shari, it has been quite a few years. I remember it because all the adults in my family are heavily into statistics and it was also somthing my mom's marketing class studied(she was a professor). AND because Wiz had ear infections like crazy for a lot or years.

I will look around and see if I can find it online, or maybe the paper copy in my old medical files about Wiz. I know I took the article in to the pediatrican AND the ear-nose-throat guy and htey were all stunned because they had just gotten more stuff from the drug rep about amoxicillin and ear infections .

If I can find it I will let you know.

Susie
 

TerryJ2

Well-Known Member
Neat idea.
I hope it works. The FDA is so understaffed, they have files that are about 10 yrs old.
They also have mgmt with-political leanings and ties to certain pharm companies, which makes them suspect.
Big article in today's paper about whether Obama will create an overhaul.
In the meantime, all we can do is hope they see our emails and act appropriately.
 
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