Pharmaceutical research symptoms and conditions

I just want to reply to you and everyone else who is having difficulty with doctors acknowledging mirena side effects. I work in pharmaceutical research and what people need to understand is that clinical trials only test on samples of about 5,000 patients and the side effects observed in those people are the ones acknowledged in the literature your doctors are referring to. The problem with that is for a drug sample population to statistically represent the actual US population it would have to be at least 30,000 people. This is not feasible even for the most profitable big pharma companies. So once these drugs get to market, there are inevitably going to be people experiencing side effects not reflected in clinical trials.

That said, I had Mirena put in 6 weeks after giving birth to my son in August 2008. Pre-preg I weighed 132, at 9 months I was 173. I left the hospital weighing 152. When i got mirena inserted i had been loosing slowly due to breastfeeding, but I was loosing and weighed 145. By Christmas 2008 I weighed 155. So I started working out, circuit training 45 minutes, 5 days a week, and eating much healthier for 6 weeks. Like others assuming it was a change in lifestyle, stress whatever. I didn't loose a pound. After no success I cut down to less intense workouts but kept eating well. By June 2009 I was 163. At 132 lbs pre-preg at 5'4" I never worked out, I'm not kidding, ever and I was not a healthy eater, I just wasn't a big eater.

So August 10th 2009 at 168 lbs and fed up, I went to the doctor to have it removed. They insisted it was not the mirena, but if for no other reason I had to find out for myself why I could not loose weight, if i was still overweight afterwards then so be it, but I had to know.

I'm glad to announce that today September 21st, I have "inexplicably" lost 21 pounds in counting. I have not worked out like I did in those six weeks, brisk walks at the most,and I have continued eating healthy. I'm not advising anyone on what to do, I just know when I was contemplating getting this thing removed, I wanted to hear from someone who had actually gotten it removed. Also, I did not the emotional or dermatological side effects others described.

I have posted a couple of times previously about negative side effects, i.e. migraines, weight gain, acne, chin hair, eczema, lower back pain, no sex drive...and the list could go on. As a mature 36 year old woman I have educated myself over the past couple of years and can really only attribute all these issues to having the Mirena inserted 4 months after the birth of my daughter 3 years ago. Although at this time my doctors will not openly acknowledge these side effects, I am confident that one day they will. I encourage women to report adverse side effects to the FDA. It onlt takes a minute or two. Who knows, it may be the hormones or it may be the silicone plastic? It has to be something. It should also be acknowledged that some women, my very best friend for one, have had wonderful experiences with the Mirena. I really think it may just depend on the woman and her own body. I am having mine removed tomorrow after researching all of this for about 8 months. All I can say is, thank goodness. I am also scheduled for the Essure(permanent birth control). Food for thought for the older women in the group. Whatever each of you decide, realize you are not alone and you do not have to continue to feel the way you do if you believe that the Mirena could be making you feel so bad. Take care.

First of all, a big thanks to all of you who have shared your experiences. I am a biochemist, with a background in pharmaceutical research...I chose the Mirena IUD after careful consideration of it's active ingredient, Levonorgestrel. The side effect profile seemed pretty acceptable...until I started to experience nearly ALL of them...I am 33 years old and had the Mirena IUD placed in October of 2008 after the birth of my second child in June of 2008. The initial reaction was to be expected...cramping, a little spotting etc...nothing to be alarmed about. I still have yet to have a period (which I really don't miss so no problem there) I never gave a second thought to this until now...for the past month or so (coinciding with the weening process, since I have been nursing the entire time, I believe the side effects were not as noticeable) I have been experiencing the following (that may or may not be related to Mirena as my OBGYN has so adamantly pointed out, but after reviewing your posts I'm willing to bet they're connected) and are in order of occurrence: Major, but temporary, hair loss after 2 months or so; Major respiratory infection lingering over a month with difficulty breathing, tightness and pain in the chest at around 6 mos; And in the past month, several instances of motion-like sickness/ nausea, dizziness, blurred vision, major impatience/ mood swings, loss of appetite (pregnancy-like symptoms...yep, I was thinking man I'd be pretty pissed if I was that 0.01% pregnant statistic), and as of this past weekend, my first aurora migraine with tunnel vision and serious nausea and vomiting, to the point where I went to Urgent Care...who referred me to the ER...who wants to perform a battery of tests including a head CT. I have an appointment with a trusted GP tomorrow to discuss possible root causes...but it is to coincidental that so many women are experiencing these same symptoms! I am certainly leaning towards having this removed. CAN THOSE OF YOU WHO HAVE HAD THIS REMOVED PLEASE RESPOND IF YOUR SYMPTOMS SIGNIFICANTLY IMPROVED OR WERE RESOLVED!!! THANK YOU!
These side effects seem to go well beyond a 5% rate of incidence according to all of you who have reported. I will investigate further and keep everyone posted. As someone who is highly experienced in the pharmaceutical industry, you bet your a$$ I'm going to get to the bottom of this! Good luck ladies!

I was put on Singulair about three weeks ago, and noticed immediately that my mood had changed. I am an adult ,and felt this sense of sadness, anxiety, solitude, not wanting to be around anyone. I took myself off the drug and have tics all over my body and eyelids ,which is driving me crazy! I even had heart palpitations ,which are very distressing. Today it seems to be better, and this is day three off the med. The only way I can explain how I felt on this drug is doom and gloom.

October 2, 2008, 7:26 pm
FDA Contract: Prescription for a Big Headache
Alicia Mundy reports on drug regulation.

It’s unusual for a regulator and the industry it regulates to share the same public relations firm.

But that’s just what’s happened with the Food and Drug Administration and the pharmaceutical industry’s lobbying arm.

Qorvis Communications, an influential PR group in Washington, was hired this year by the FDA as a subcontractor to help heal the agency’s ailing image with a $300,000 “FDA 2008 Public Awareness Campaign.” Qorvis, however, has been working for the Pharmaceutical Research and Manufacturers of America, the Washington-based lobby for drug makers, since 2006.

Ironically, the FDA has been under fire for being too lax in enforcing drug safety regulations with PhRMA’s members – and the big effort to burnish its reputation has backfired.
Qorvis also has been representing UST Inc., whose U.S. Smokeless Tobacco unit is the largest American maker of chewing tobacco, which supports a controversial bill in Congress that would allow the FDA to regulate the tobacco industry. The FDA commissioner has opposed the bill. UST is being acquired by Altria Group...........................this was in yesterdays Wall Street Journal...maybe if they did their job right they wouldn't need a publi relations group to up its image,maybe if they separated themselves from the drug companies we would believe them