Docket Management
Docket: 00N-1637 - Advertising & Promotional Labeling for Drugs & Biologics
Comment Number: EC -7

Accepted - Volume 1

Comment Record
Commentor Mrs. Stephanie Morales Date/Time 2001-02-19 23:21:20
Organization Mrs. Stephanie Morales
Category Individual

Comments for FDA General
5. General Comments I only heard about depo-provera twice, before deciding to get the shot myself. One of my friend's sister was on it after her first child and I knew she was having trouble conceiving (took 5 years before conceiving her second). My other friend was on it and didn't seem to have problems until she started to try and conceive her second child (she has miscarried and as far as I know became very depressed, before moving). After having my second child 13 months apart from my first I decided to find a birth control. I knew I would have feelings of wanting another baby before the time was right, that is how I ended up with the two I have, so close, so I knew condoms wouldn't work. Birth control pills was the next option, but I had a hard time remembering pre-natal vitamins let alone trying to remember a BCP everyday around the same time with 2 babies needing me constantly. So that option was out. IUD's had a chance of puncturing the uterus. And a few others seemed like too much of a hassle for me. So Depo-Provera seemed like the right choice. I was told I only need to worry about it every 3 months or so. I would stop menstruating after about a year of using depo. I was only slightly educated in some of the side effects from my experiences of my friends. So I asked questions that concerned me. My friend miscarried after taking depo, is that a side effect? The answer I received was a resounding NO that it was not a documented side effect of Depo-Provera and that it is just a coincident in some women. I also asked I am looking to get pregnant again in about 9 months, should this be a problem? their answer Well most women tend to take about 12-18 months to get pregnant again, even after the first shot, and some women tend to get pregnant right away, so it is hard to determine from woman to woman. Still not a clear answer. So I took home the brochure and read it over with my husband. We discussed the pros and cons of what was written in the brochure as side effects. ( I strongly urge you to read one and judge for yourself.) None of the side effects seemed to terrible and none of them were said to be a side effect every woman will have, almost like they were down-playing them. The only one that they seemed to repeat the most was not having a period.( Well, hell who wants one to begin with. If I could be fertile and Aunt Flow free I would.) It didn't sound like a bad side effect to me at all. So my first mistake was about to take place. About 3 months after delivering my second daughter, I went in and received an injection of Depo-Provera. I was astonished by the uncontrollable acne I was having, but didn't thnk it was from the depo. But who has acne that lasts for 9 months straight?! I cetainly never did til now.I didn't have a period for 9 to 10 weeks before I started to bleed. I bled lightly for 3 weeks where I went in for my 2nd shot. At that time I asked the nurse practitioner a few questions. I asked if bleeding for 3 weeks was normal, and the answer was a, yes. I also at that time mentioned about wanting to try for a 3rd child towards the end of the year, (which to me now should have been a clue for the NP to ask a few questions of me and or not recommend Depo to me as a patient.). She just said , Oh how nice, so hopefully we will see you back in here then for a different reason. (wink, wink) So I felt a little better. It was about 6 months after I gave birth and now after a 2nd injection, things started to come together as suspicious. I didn't know at the time what was happening to me. But only after learning a lot more through research and my own experiences did I truly know what happened. So now six months post birth my mind was still not coming back to me, ( a pregnant woman's brain will shrink 3-5%, thus causing the temporary absent mindedness, and or forgetfulness. It takes an average of 6 months post delivery to regain full capacity.) it actually seemed to be getting worse which frustrated me beyond belief. I couldn't think of simple words for things that were right in front of me. I would forget appointments and I would stumble my words and stutter when speaking to some one, which made me feel stupid at times. I knew I had a 130+ IQ so what was wrong with me. I started to get irritated at the stupidest, smallest, things and would take my anger out on my husband. I threatened suicide and even attempted it by consuming 2 boxes of sleeping pills. I the felt guilty for getting upset at him, which only made me wonder about my ability as a wife and mother, and made me even more depressed. I feared my husband would leave me, which made me push him away when I needed him the most and he had no clue as how to deal with me. Pushing him away made him not want to be around me, when that was all I wanted from him. But how was he supposed to know. At one point I saw a Dr. Phil show on Oprah saying tell your husbands what you want from them. So I did. I point blank told him all I needed from him was 3 things #1 hug me once a day even if I fight it, because that might be when I need it the most. #2 Kiss me passionately once a day, and leaving for work doesn't count, and last #3 take the garbage out on your way to work. I even wrote it down for him. But he still has a hard time accomplishing any of them. I would cry for no reason. I was tired all the time and slept whenever I could, while letting the TV and kids movies baby-sit. I had no energy, no desire, and no will to do ANYTHING other than sleep. I would sleep all day and then sleep more at night. In between diaper changes, bottle feedings (between 2 kids),and daily chores, which sometimes wouldn't get done at all during the week. The weight started to creep on. I hadn't changed my eating habits at all, in fact I was eating less because I was sleeping more, and over the course for 6 months gained about 20 - 30 lbs.. My hair would fall out and as September approached a whole plethora of new symptoms were invading me. I never had a kidney infection in my entire life until this fateful September. My side was killing me I could barely walk. My fever was reaching beyond 103. We had a few pain killers left over from previous diagnoses, but they barely dulled the pain. I was nauseous, and had no clue what was happening to me. After a ride and a couple hour wait in the hospital, I was diagnosed with a kidney infection. Okay, but why did I get it. You would be amazed at how quickly a doctor will tell you, and how even more quickly they will dismiss it as a side effect. (Why is that?!) Later after reading other women's posts I found I was not the only one who ended up with kidney infections. Back to August, I started to have mild migraines and constant headaches which progressed in getting worse every week or two, with occasional tingling sensations in my fingers and feet. By the end of October my husband convinced me to have a neurologist look at me. He ordered an MRI and an MRA. I was nervous that maybe the memory loss and the headaches were going to turn out to some kind of cancer and I might die leaving my children and family behind. But at the same time hoping they would find something just so I would know I wasn't going crazy. The MRI ended up showing that I had a congenital defect called Chiari-malformation, an over growth of cerebellum that falls into the brain stem and blocks the flow of cranial fluids, causing headaches and tingling. My Dr. also said that I had a good flow of fluids and that it wasn't the cause of my memory loss. This just left me kind of empty, I wanted my memory back and all my neurologist said was that I might need to retrain my brain, and with that left. He took all of about 10 minutes with me never sitting once to discuss anything and left. This made absolutely no sense to me,and very angry, but my Dr. at the time wasn't interested in my theories. Back to mid September, I started to bleed again about 3 weeks before the next injection was about to be due so I didn't think anything of it. I assumed it would stop in about 3 maybe 4 weeks. Not my luck at all. I did not stop bleeding for about 2 and a half months. At that time I stopped for a couple days towards the end of November and started to have pregnancy symptoms, so I took a couple of home pregnancy tests, which came back positive. I was happy but at the same time in the back of my head I kept thinking I was going to miscarry. I set up a Dr. appointment with my OB and told them I had a positive HPT and was spotting. At the word spotting, they decided to have me come in that day to test and make sure. The next day I tested again and found a lighter and diminishing pregnancy test staring back at me. Later I got a call saying I wasn't pregnant.I believe I miscarried. The next day I started to bleed again. This time I was sure it was just a period. Two weeks went by before I stopped bleeding. As of right now while writing this I have not had a period for, going on now, 10 weeks. It would be nice except I wanted to be pregnant by now!! Getting pregnant gets even more difficult when the total thought of sex or even desire is non-existent. I was not turned on by anything. I love my husband and wished I could be more fun or useful in the bedroom. But I just do not want anything to do with sex, other than to appropriate. I would only put out when I thought there might be a good chance at conceiving. Even then I wasn't really into it. I still had my original prenatal appointment set up for Dec 28th. I went this time with my husband to discuss options in our efforts to try and conceive again, and to check my thyroid. I had just heard that a thyroid problem can cause a lot of the symptoms which I was experiencing (came back negative to my disapproval). So we decided, with our Dr., to try until mid March, the natural way. If we weren't pregnant by that time, he will then start me on a low dose Birth Control Pill. I would be on this until July of 2001 giving my body a chance to try and re adjust for a month where we will pick up again TTC in Sept 2001, If by the end of the year, 2001, we still haven't conceived, the next option would be for another drug, to try and get me ovulating, called Clomid. I didn't come across the web site until late January. After reading a lot of the stories and crying a lot. I was able to realize what had been happening to me for the past 8-9 months. I was able to realize what my irrational behaviors were from, why I had my memory loss (which is slowly returning) the kidney infections, and the whole slew of other problems. Stephanie Morales P.S. I apologize for it being so long, I only hope you got something out of it, and I would be extremely grateful for anyone who read this completely. Thank You for reading my plight. I am starting to think of this drug as a conspiracy to get us to pay more, through all of the extra testing, drugs, and treatments. Just so a doctor can make a buck. But how many lives will be sacrificed before some one takes this POISON for WOMEN off the market

EC -7