Drospirenone symptoms and conditions

I am in my second month of Yaz having switched from Yasmin -- Yasmin (or rather, the generic form) did not seem to have perfect results for my acne and after a year I decided to switch to Yaz because I thought that the longer amount of the drospirenone would help my skin.

Unfortunately, it seems as if my skin has gotten WORSE. I have no cysts on my face, but I have a lot of small whiteheads on my forehead and around my chin. And additionally, I seem to have little bumps on my chest and back -- places where I never had acne before. While my skin was not perfect with Yasmin, it was DEFINITELY clearer and more manageable, and this is just terrible.

I am worried that this is because Yaz has less estrogen than Yasmin. Is it the estrogen or the drospirenone that helps prevent acne? Is this just my skin reacting to the change in hormones? Should I stick with Yaz for a third month, or should I switch back to Yasmin at the end of this second month? How long should I wait before giving up?

I should also note that I started Epiduo gel about two and a half weeks ago, so I don't know if that would contribute to the fact that my acne has been getting worse, too.

HELP!

I am 41 years old; I've been on several different birth control pills since I was 19 (never had any problems with any of them). I took a break for 2 years recently while trying to get pregnant. After two miscarriages, I decided to go back on the pill until the genetic tests come back.
I am into my 3rd pack of YAZ pills & all I can say is they are by far the WORST birth control pills I have ever taken. After reading all of the side effects that are posted, I am discontinuing immediately. It also eases some of my worries that I am not the only one suffering. These are the side effects that I have experienced since starting YAZ:

1. Daily migraine headaches.
2. Throbbing pain in my head if I turn too quickly.
3. Sensitivity to light.
4. Frequent cramps in my feet.
5. Clouded vision & sharp pain in my eye sockets.
6. Sinus pain.
7. Constipation.
8. Ringing in my ear.
9. Insomnia.
10.EXTREME mood swings.
11.Depression.
12.ZERO sex drive.
13.Fatigue, along with constant neck & back pain.
14.Painful cyst-like acne on my face.

With all of the birth control pills out there, there is no reason to have to take YAZ. It is the only pill on the market that contains drospirenone, which leads me to believe that drospirenone is causing the side effects I am experiencing.

I am 49 and my bad acne started to return and I started getting a receeding hairline. My OB put me on Yaz. The hair has continued to reced at an alarming rate - so it did not help with that. I still am breaking out alot, but I have since discovered a device called the ZitZapper which works really well (I wish it had been invented 30 years ago when I was at my worst). My skin has dried out alot which I really like. It's still oily in comparison to other peoples, but at least my eyeliner is not melting in 4 hours like it used to. I have no experienced any of the moodiness others complain of.

But I have gotten a yeast infection every other month and I am very dry. And my sex drive has never been lower. In fact, I have no sensation in the exterior tissues; I cannot acheive an orgasm, which I have never had problems with at all. The drospirenone in Yaz is derived from a "water pill" that gives men erectile disfunction, so the lowered libido is not a surprise.

I have lost weight (about 5 lbs); the pill makes your appetite diminish, especially if you drink alot of water. My breasts seem fuller but are not sore. In general I like the effect it has has on my body.

The first week of every month, I feel very tired but this only lasts the first week.

The package insert fot YAZ is clear that you should get tested for Potassium levels your first month. Your kidneys cannot process the minerals and be trying to clear other substances. The itching all over that I was feeling and others complain of - this is limited kidney function. A blood test will confirm this.The first month I was on Yaz I could not eat any high potassium foods without feeling sick. I ate a can of tuna and was sick for 2 days. I had a weird metallic taste in my mouth for the first 6 weeks. I can pretty much eat anything now without feeling sick.

I take fish oil daily to thin the blood to try to stave off clots.

I am going to try something else though to try to stop the hair loss.

Yaz and Yasmin are two different pills!

(http://www.yaz-us.com) For Yaz

(http://www.yasmin.com) For Yasmin

I have been taking Yasmin for 2 months now and everything is going great!

I just wanted to post this because I noticed that some of you seemed confused and you were mistaking Yaz for Yasmin and vice versa.

I did hear a lot of bad things about Yaz though. Please check out the websites.

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service Food and Drug Administration
Rockville, MD 20857
TRANSMITTED BY FACSIMILE

Nancy Konnerth
Associate Director,
Advertising and Labeling
Drug Regulatory Affairs
Berlex Laboratories
340 Changebridge Road P.O. Box 1000 Montville,
NJ 07045-1000

RE: NDA 21-098 Yasmin (drospirenone/ethinyl estradiol) Tablets
MACMIS ID# 11730

Dear Ms. Konnerth:

This letter notifies Berlex Laboratories (Berlex) that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a direct-to-consumer (DTC) broadcast advertisement (TV ad) for Yasmin (drospirenone/ethinyl estradiol) Tablets that is misleading and in violation of the Federal Food, Drug, and Cosmetic Act (Act) and applicable implementing regulations. Specifically, the 60-second TV ad entitled "Goodbye Kiss" is misleading because it makes implied clinical superiority claims to other combination oral contraceptives and minimizes the important risk information that distinguishes Yasmin from other combination oral contraceptives. As a result, the TV ad raises significant public health and safety concerns. Background Yasmin is a combination oral contraceptive ("COC" or "birth control pill") prescription drug product. Yasmin, like any oral contraceptive, is associated with increased risks of several serious conditions (including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension), although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.

The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. (See the WARNINGS section of the Yasmin approved physician labeling (PI)) Yasmin contains the estrogen ethinyl estradiol and the progestin drospirenone. Drospirenone has antimineralocorticoid properties, which means that it can work against the body's normal mechanism for regulating salt and water balance, a situation that can lead to hyperkalemia in high risk patients, resulting in potentially serious heart and health problems. This additional risk is described in the Bolded Warning of Yasmin's PI: Nancy Konnerth. 2 Berlex Laboratories NDA 21-098 Yasmin contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in highrisk patients, comparable to a 25 mg dose of spironolactone . Yasmin should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium, should have their serum potassium level checked during the first treatment cycle. Drugs that may increase serum potassium include ACE inhibitors, angiotensin -- II receptor antagonists, potassium-sparing diuretics, heparin, aldosterone antagonists, and NSAIDs.

Consequently, Yasmin can exacerbate serious heart and health problems, in addition to the potential problems common to all COCs. Women taking Yasmin must be concerned about drug interactions that will increase potassium, in addition to the drug interactions common to all COCs. Therefore, these women and their healthcare providers must weigh Yasmin's additional health risks when considering Yasmin over COCs without drospirenone. Misleading Efficacy and Safety Presentations Prescription drug ads are false or misleading if they contain a drug comparison that represents or suggests that a prescription drug is more effective or safer than another drug when it has not been demonstrated to be safer or more effective by substantial evidence or substantial clinical experience (21 CFR 202.1(e)(6)(ii)). The TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone. The unifying theme of the ad, typified by the tagline "Ask about Yasmin, and the difference a little chemistry can make" (emphasis added) suggests that Yasmin is better than other birth control pills because of drospirenone and the way in which it is metabolized in the body. This "chemistry" difference is presented as a product benefit. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone as communicated in the Warnings/Bolded Warning, and Precautions/Drug Interactions sections of the PI.

Specifically, the following claims in the TV ad address Yasmin's efficacy: "You don't settle when it comes to the guy...so why settle when it comes to the pill? The Yasmin birth control pill uses a different kind of hormone. One that may work with your body chemistry. Yasmin is over 99% effective at preventing pregnancy. So when you're looking for the right pill, ask your doctor about the difference a little chemistry can make." (emphasis added) These claims are misleading because they suggest that Yasmin's "different kind of hormone" offers unique "chemistry" benefits and that this difference contributes to the high rate of drug efficacy. Moreover, these claims are misleading because they imply superiority to other COCs (and thus do not offer the same product benefits as Yasmin Tablets) when such has not been demonstrated by substantial evidence or substantial clinical experience. Finally, these claims are misleading because they misrepresent Yasmin's mechanism of action by stating that Yasmin "uses a different kind of hormone. One that may work with your body Nancy Konnerth. 3 Berlex Laboratories NDA 21-098 chemistry." However, COCs, including Yasmin, prevent ovulation by working against the usual body chemistry of a woman of childbearing potential by suppressing endogenous gonadotropins and, thereby, inhibiting ovulation and altering other changes associated with the menstrual cycle.

In addition, the statement "Yasmin contains a different progestin, which may increase potassium" is misleading because the "may increase potassium" disclosure fails to communicate that the potential to increase potassium is a risk. Furthermore, consumers may interpret the statement as a product benefit claim rather than a risk disclosure due to the overall positive message that Yasmin's "chemistry" is a product benefit. The ad conveys this positive message to consumers, notwithstanding the disclosure that "You should not take Yasmin if you have kidney, liver, or adrenal disease," because the "different kind of hormone" and "chemistry'" messages are never clearly identified as potentially leading to increased potassium levels or that increased serum potassium can be dangerous. This important risk information is in a Bolded Warning in the PI and clearly conveyed in the Yasmin Brief Summary Patient Package Insert and in the Detailed Patient Package Insert: Yasmin is different from other birth-control pills because it contains the progestin drospirenone. Drospirenone may increase potassium. Therefore, you should not take Yasmin if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether Yasmin is right for you, and during the first month that you take Yasmin, you should have a blood test to check your potassium level. Thus, by failing to add the necessary context to clarify that increased blood potassium is a safety risk rather than a clinical benefit, the ad misleadingly represents or suggests that Yasmin is safer than has been demonstrated by substantial evidence or substantial clinical experience. In summary, the TV ad not only misleads consumers about the efficacy of Yasmin, the ad also minimizes important context about the health risks of the drug. ]

Conclusions and Requested Actions
Berlex should immediately discontinue the TV ad and all other promotional materials and activities for Yasmin that contain the same or similar violative presentations. Berlex should submit a written response to DDMAC on or before July 24, 2003, describing its intent and plans to comply with the above. In its letter to DDMAC, Berlex should include the date on which these and other similarly violative materials were discontinued.

Berlex should direct its response to the undersigned by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications HFD-42, Rm. 8B-45, 5600 Fishers Lane, Rockville, Maryland 20857.

Nancy Konnerth. 4 Berlex Laboratories NDA 21-098 In all future correspondence on this matter, please refer to MACMIS ID# 11730 as well as the NDA number. DDMAC reminds Berlex that only written communications are considered official. Sincerely, {See appended electronic signature page} Joan Hankin Consumer Promotion Analyst Division of Drug Marketing, Advertising, and Communications

--------------------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. -------------------------------------------------------------------------------------------------------------------- /s/ --------------------Joan Hankin 7/10/03 03:40:53 PM

hi ladies,
further to guest 35696 's point about reporting side effects to the fda etc here is the website for the uk's equivelent. www.mhra.gov.uk click on the "yellow card" tab this will send a report about the side effects of medicine. if you also want to look up reported side effects then go to the download side effects page but remember when you do the alphabetical search that yasmin will be listed under it's chemical ingredient (D for drospirenone not under Y for Yasmin.) it makes for quite interesting reading.
It really is very important that we report the bad effects as if no one reports it, it will never be taken off the market or even prescribed with more caution than it is now,it is our responsibility to try to protect other young ladies from this hell that we have all suffered.

silke,maybe i have mis-read the previous post, i find it so hard to figure out meaning when reading a post or text messages,a perfectly harmless comment can sound rude in a message, as i said i did not mean my posting to sound rude,i agree that we should have a "chat room" for all the ladies who want and need contact with other sufferers,this site is getting pretty heavy going now for newcomers that are just looking to see if their specific symptom is here.there are a lot of pages to get through!!!!! if i knew how to start up a chat room i would do it myself but i am a total idiot at anything to do with computers!
hope your gig went well the other night,i love the abba song you were going to sing.

remember ladies please report your side effects.

sarah

Also just a note Dejay and I took Yaz not Yasmine same maker same company the wicked step sister to Yasmine Iam not sure if the ingrediants differ or not Yaz has drospirenone and ethinyl estradiol 3 mg/0,02 mg 28 tabs

Does this mean anything to anyone??

to gigi:

Yes, there are many women here on this site, who have experienced weight gain after stopping Yasmin!! I've posted several times about this here. Perhaps you should read more posts on this site, it really might help!!

But I'm not sure, if it's really good to take another diuretic against the water retention now. You should know, that Yasmin's hormone "drospirenone" is very similar to a diuretic named spironolacton. So all of us were taking a water pill with our bcp without knowing for a long time.

And everywhere I searched in the internet and even asking my doctor brought out, that a withdrawal effect of diuretics is more water retention then before taking such pills!!! Thats the explanation for the massive and in most cases immediate weight (or the better "water-") gain many of us were experiencing after stopping Yasmin!! My weight gain doesn't seem to look "normal", too, it looks just like every cell of my body was filled with water, a really unnormal look (and I swear before Yasmin I was a very fit, thin and good figured person!!). Everybody who knows me and especially has known me before this Yasmin desaster tells the same!!

So I and even my doctor think, that it might be better to let your body recover first before taking another chemical against the weight gain and especially going on diswatering your body with a diuretic. You might not get out of this vicious circle if you don't stop every medication that is diswatering your body!!

I know (and I mean I REALLY know!!) what it means to go through this massive weight gain (I had gained about 30 pounds after getting off Yasmin without eating more or doing anything else different than before and I went up 2 sizes in clothes, which was and still is really shocking for me!!! I SWEAR!!) without being able to do anything against it unless my body hasn't fully recovered from this Yasmin poison, yet.

But the only chance seems to be to give your body and all the diswatered cells the time they need to get back to normal by themselves!!!

Please think about that and probably talk to your doctor!! Not every doctor knows that the drospirenone in Yasmin is working like spironolacton but it really is!!! If you have any doubt about that, you might search google or anything else about drospirenon and diuretic or spironolacton. And you'll find out, that all the effects we are now experiencing (even the muscle fatigue in my case or cellulite and so on) are the same as you get if you have taken any diuretic or especially spironolacton!!

All the best to you out there and everybody stay strong!! We'll be better and pretty again some day!!! ;-)

@guest 13099:

I completely agree with sherry!!

Perhaps it might help you a little bit to read my post Nr. 12857 (page 4 or 5 on this site) where I had written my and my family doctor's theory about this extreme weight gain after getting off this horrible pill.

A few days ago I got even water in my feet (they looked like they were completely pumped up with water and even poured out of my shoes, I was so shocked!!!) which I never had before in my life!!!

Yesterday I found a website where the effects of diuretics were reported (Yasmin, or better the drospirenone in it is very similar to a diuretic named "spirolacton"!!! and so this pill diswaters your body the whole time while taking it!!!). It was very interesting to read, that if you get off such water pills your body may retain the more water than before taking the water pills. So it's pretty normal how some of us are "bloating up" I fear... :-(

I just hope (and my family doctor also thinks so!), that if I give my body enough time to recover, all this water and bloatedness will go away by itself when everything in my body is working normal again.

So there is hope for all of us but we need much more time and patience!!