Gallbladder disease symptoms and conditions

Hi there... I came off of Yasmin just 2 weeks ago and thought I should share with you my story since yours is a skin issue. I took Yasmin for 3 years. This past year I would wake up some bumps on my lip.. then on my hands.. then (this is over a period of months) I would wake up and have a slightly swollen lip... this was over the last year or so. I would also get a feeling in my throat, like something was in it and swallowing felt funny.
WELL, 2 weeks ago, I took my bc like I always do, right before I go to bed and my lip starts to tingle and itch.. and in the morning my face was swollen 3x the normal size on on side, mostly at the lips... I couldn't really talk.. it was like those awful photos on google. It was angioedema and can kill you by swelling of the throat. I had also for about a year- an ear issue.. it would sound like I was talking under water and felt like swimmer's ear- related to the swelling I found out later. Turns out I'm allergic. I developed this allergy over the period of time I was exposed.

I just want to say to anyone out there that has FACIAL/LIP SWELLING, or swelling of the hands... GO TO THE ER. It can kill you. I got lucky.. my swelling started slow and after about a year if was full blown. It is not something to mess around with!I was prescribed an epi pen. I developed an allergy to a preservative in it and I'm not an allergen sensitive person. That was just the parms/doctor guess I might add.

The first year I took Yasmin I had numb and tingling toes. and the whole tie I've had on and off leg pain.. no sex drive, that's the truth..definite bloating issues about 6 lbs weight gain, sometimes more without change in diet. I haven't noticed any hair loss thankfully. Migraines. Lots of nausea in the morning, every morning like morning sickness. Car sick even when driving.. not normal! I used to work on an airplane and I never got motion sickness.

I'm now on day 4 of Mirena IUD and I'm having having severe diarrhea and trouble sleeping.. I really, really don't want to get pregnant. Our next step is a vasectomy for the hubby. I'm 25 and I weigh 140 5'10 if that helps. I wasn't an 'at risk' like the pamphlet said.

I was on yaz for close to 4-5 years. I started taking antibiotics and my husband and I became pregnant while on the pill. We were well aware of chances of becoming pregnant. From the day I found out i was pregnant I started throwing up. I LOST 15 pounds during my pregnancy due to being sick all of the time. I had constant heartburn and choked all of this up to being pregnant with a little girl with a head full of black hair! The day my husband was suppose to go back to work from his leave (exactly 2 weeks after having my baby) i started throwing up at about 3am due to intense stomach pain that radiated into my chest and back and couldn't stop. He stayed home. The next day it happened again, my husband assumed i had postpartum depression and told me i would be fine and left for work. I tried to go back to bed but couldn't stop throwing up long enough to go into the next room and check on my crying newborn. I had to beg him to come home from work, we got a babysitter, went to the hospital, they did an ultrasound and admitted me. 12 hrs later I was on the operating table having my gallbladder removed. I now suffer with DAILY diarrhea immediately after I eat ANYTHING and stomach pain. I try to stick to a low fat diet but it doesn't help!!!! i have constant stomach pain, headaches, nausea and heartburn. Not to mention the FOUR scars that i have from the surgery. When i started taking Yasmin and eventually yaz NOWHERE did it say that it could cause gallbladder disease!

Hi, I am a mother of 2, and not quite 23 years old and got the Mirena inserted at my 6 week check up after having my second. I read all the literature that the Dr. gave me and I was sure that Mirena was the right thing for me (no where in the brochures did I read anything about the symptoms Ive read about here or anywhere else on the internet). I started having incredibly horrible mood swings, bloating, fatigue, nausea (sooo bad, every day) back pain, neck pain, no sex drive (!!!), depressed, lazy, headaches (to the point where I thought my head was going to explode), constantly hungry, acne, smelled maple syrup constantly, complaining all the time about everything, weight gain (only 7 lbs but I just had a baby, I need to lose weight, and I'm nursing),chest pain, and some other symptoms but the most important one is the stomach pain i was having. The pain in my stomach felt like a knife, and I kept having pain in my right side. So after a few days of this pain I went to the dr. he ordered an ultrasound of my abdomen and I am scheduled to get that done Wednesday. My doctor thinks that I may have gallbladder disease or something else seriously wrong with me that we suspect is induced by the Mirena. Keep in mind that I've had this thing in me for about 4 months!!! So after my doctors appointment I typed into google "side effects from Mirena" and Omg, I wish that I had done that before I got the thing inserted, those brochures about the Mirena make it seem like a Godsend and I am all for a lawsuit due to the problems I am having and the depression Ive felt. My 3 year old has suffered from my mood swings, every time id feel it coming I had to make her go to her room :( that poor girl deserves to have a mother that is not so depressed and ill that she can actually play, and both of them deserve that really, and im doing the best I can.... anyways I removed it myself yesterday, i had a hard time finding it but I took it out and I feel as if a huge burden has been lifted, EXCEPT I have been cramping very bad, spotting and incredibly sick, i also read about this thing called "the mirena crash" no matter how long you've had it in, if the hormones were in your system then you are effected and can feel very ill from it (and it can happen to women who had no problems while on it at all, even after 5 yrs). Im hoping that I have nothing wrong at my doctors appt on Wednesday when I get the ultrasound, and it may just be a cyst, turns out that is a side effect of mirena as well, that and bleeding the first several months (oh yeah, I did for about 2 months maybe 10 weeks altogether) Im also hoping that my daughter whom I am nursing is not sick as well :/

oh and for anybody out there thinking that the only women gaining weight are fat to begin with, well I am usually 105 lbs, after my baby I weighed 145, lost some weight, went down to 130ish gained it all back then some, losing weight is easy for me because I diet and exercise like I should, now I am doing all that and nursing a child.... and hello weight, when it really should be goodbye... well goodbye mirena I WONT miss you!!!!

I too have been experiencing the same side effects listed by most of you. I have also been seeing a gastroenterologist for about 9 months now because of stomach issues. All symptoms point to gallbladder disease but the tests come back normal. I called my gyne today and they seem unconcerned with what I have told them and advised me to continue to take my pills until my annual visit in October. I'm done with this pack on Saturday and am thinking of going sans pills for the next month until my appt. Any advice on what pill I should switch to when I do see my dr.?

I am 24 years old. I started using the Nuvaring about 9 months ago, back in November shortly after my youngest son was born. In January, only two months after starting it, I was beginning to have severe stomach pains and a lot of nausea that would come and go throughout the day. I went into the emergency room one night because it got so bad and they told me that I was going to have to have my gallbladder removed due to large stones. I'm trying to figure out whether anyone else has had any similar issues with the ring. I have read here and there that gallbladder disease is a side effect but I also have issues with it in my family. Has anyone else had a problem with this? I have also dealt with a lot of depression, headaches, slight weight gain, mood changes (just as bad, if not worse then while I was pregnant) and I am going to have to schedule an eye exam because it seems like the past few months, my eye sight has just gone down hill fast. I have never had to wear glasses or contacts.

Has anyone else out there had issues with their gallbladder and eyesight? Most of the posts that I see are saying issues with hair loss and depression. I am seriously thinking about talking to my doctor about changing methods, I was just wondering if there are people having symptoms like mine or whether I need to attribute them to something else. Any information would be helpful, Thanks.

I am a perfectly healthy, 24-year old young lady in excellent mental and physical health. I eat right, exercise regularly and I have no history of any health problems. In August of 2007 I started taking Yaz, it was prescribed by my gynecologist and I always got free samples, so I began taking it. In November of 2007 (almost 4-months after starting Yaz) I began having severely painful and scary gallbladder attacks. After multiple tests, I found out that at 22 years of age, my gallbladder was functioning at 0% and had to be removed immediately. I always thought that it was odd and my family did too because there is no history of gallbladder disease in my family at all and I was way too young and healthy to have my gallbladder fail. During the first few months of taking Yaz, I noticed that I was moody and tired beyond belief. I lost a few pounds though. For the first couple of months, my acne got worse, but then around the same time that I had my gallbladder removed, my acne started to improve pretty rapidly. A couple of months later I was diagnosed with IBS and have suffered digestive problems since.
I was in a relationship when I started taking Yaz and for no reason at all I lost all interest in sex and developed anxiety and an aversion to touch and in January of 2008 I broke things off with my boyfriend for no reason at all. In March of 2008 I started having severe anxiety and panic attacks. At times I even had thoughts of dying and thought that "at least I won't feel this way anymore."
To soothe those feelings I began drinking and partying and found that I felt better with the calming effects of alcohol. I drank at least 4 nights a week for about two months until I started gaining weight from the drinking. I don't have an addictive personality at all and so I just quit drinking cold turkey. It tasted horrible anyways.
In May 2008 I met the most wonderful man in the world, and yet, I was unable to ever really "feel" anything for him and I always felt emotionless and empty. My anxiety and panic attacks continued and I absolutely had no sex drive. We would have sex, but eventually my aversion to it took over and we began fighting for no reason at all and I became panicky and depressed again. In July 2008 I developed a severe allergic reaction to peanuts and had to be taken to the emergency room. I have never had any allergies and have enjoyed peanuts all throughout my life. In August of 2008 I developed an allergy to penicillin and broke out in hives. I had never been allergic to anything in my life, and all of a sudden, I had two allergies!!!
In September of 2008 my immune system went down the drain and I developed a severe and life-threatening MRSA infection. I was in and out of the emergency room for a week straight and didn't get better from it for over 3 weeks. The doctors thought I had to have some sort of AIDS or Cancer to be getting MRSA at such a young age....but all tests came back negative multiple times and they just shrugged me off as an exception to the rule.
In October of 2008 I got a severe intestinal infection called c. diff.
This took two weeks for me to get over and was absolutely horrible!!
What was happening to my body??
What was happening to my immune system??
In November I started having problems with my blood sugar and I always felt like I was on the verge of passing out unless I ate on a constant basis.
It was horrible!!!
By this time, my acne was gone, my periods were shorter...thanks Yaz.

But, I had
Migraines/Severe Headaches
Fluctuating Appetite with weird cravings for salty and sweet foods
Low Blood Sugar with light-headedness and weakness
Blurry Vision (even though my eye doctor has told me repeatedly that I have perfect vision)
Brain Fog
Severe Anxiety
Panic Attacks
Nervousness and Restlessness
Inability to pay attention
Moodiness/Snappiness
Depression
Long episodes of ataraxia where I just couldn't feel any kind of emotion
NO SEX DRIVE
An aversion to touch
Hot flashes
Body aches
Thinning hair
My gallbladder quit functioning
I had a very weak immune system
and I had developed allergies to things I had been in contact with all my life...
I had back aches and neck pains
And I had severe Insomnia in spite of the fact that I was exhausted all the time! And when I did sleep it was worth nothing....
In January of 2009 I quit my job and dumped my 'perfect' boyfriend.
In February I was unable to get a hold of any Yaz bc and therefore since I wasn't having sex, I skipped February. I felt better in February and never made any connection and so I got back on in March and since then I have never felt worse in my life!!!! I've been doing research on the effects that Yaz and other bc hormones have on our bodies and it is astonishing how much it can psychologically and physically damage our bodies. I have felt like I am going crazy and slowly dying for NO REASON AT ALL>
Yaz is a nightmare!!!
I have been off of it now for 2 days and even though I still have some of the same symptoms, I can slowly feel myself getting back to normal. I've been told that it can take up to 2-3 months to get bc completely out of your system and for your body to adjust so I'm coping and being hopeful.
During the last month or so, I have even considered taking anti-depressants and anti-anxiety medications because my life is a nightmare, luckily I looked deeper into my situation and discovered the culprit b4 I put something else in my body...
Yaz is not worth it.
I will never recommend it to anyone.
The pharmaceutical companies don't give a crap about us!!!
They just want our money and don't give a shit what their chemicals do to our bodies!!!
When I have little girls of my own someday, I will never let them take b.c.
I have been letting all of my friends and family know.
I would love to participate in a class action suite or an anti-Yaz campaign....
Anything. If you know let me know because I don't ever want anyone to have to go through what I have gone through with Yaz.
Ladies....Please do significant research before you ever put anything into your bodies.

17/male

okay so today is Wednesday, ive been having really bad headaches for the past two weeks, i don't know why, but on Monday, my eyes started hurting whenever i looked anywhere else but straight ahead, really intense dizziness...Tuesday, the dizziness subsided, id been on dayquil/nyquil since Monday morning and stopped it Tuesday night

Wednesday - i stayed out of school all day, doctors diagnosed a sinus infection, and gave me the Zpak...

so since Monday, i hadn't crapped....i don't know if it was just what i had been eating, the illness, or what, but right when i took the Zpak's double dose, ive been dealing with stomach cramps and diarrhea. i got some kind of rash on my abdomen as well, im worried to find out what other side effects come on from this drug...

sweats, fatigue, anxiety, major leg cramps, weight gain after getting of it! terrible sleep and insomnia! I am now using nuvaring...no trouble. any and everything seems to make my stomach swell after having used it...i also developed a golf ball sized cyst...and got gall bladder disease. major nausea for no apparent reason! I got off of it when i couldn't stand the idea of having another period after already have 5 in a 60day span. I am still not better after three months! Ugghhh! After being sick with gallbladder disease and these symptoms/side effects...I am feeling hopeless and terrible! Yasmin sucks! But it was taken in hopes of a clearer complexion...it's odd that it actually got worse.

God Bless all of the others who have and are going through what I am...

oh and here is the birth control pill side effect list...

Common side effects of oral contraceptives include loss of sex drive (libido), headaches, acne, weight gain, vaginal infections, and depression. Current research indicates that oral contraceptives increase your risk of acquiring HIV if your partner is infected. Oral contraceptives also have some uncommon but serious health risks associated with their use, especially among smokers; these include abnormal blood clotting and heart attacks, breast cancer, and gallbladder disease.

I took Yaz for a month and a half and ended up with gallbladder disease! Which there is no cure for and needed surgery to have it removed. This seems to be a risk with all oral contraceptives but I've taken other brands years ago for long periods of time and this never happened. My symptoms were severe pain (lasting several hours) after eating ANY food containing fat. I lived on toast and soup for over 2 months. This drug is evil.

Nuvaring has worked in preventing me from getting pregnant a second time. But what I believe I got from using the Nuvaring is Gall Bladder Disease. There are 2 types of gall bladder disease and I have one of them. I have stones in my gallbladder. And because of that I have to have surgery to get my gallbladder removed. I found that out myself after doctors told me I have stones in my gallbladder. The doctors did not tell me that it was caused from using the Nuvaring. I decided to read up on the Nuvaring after I found out I had to get surgery. One of the side affects of Nuvaring is gallbladder disease. Now I know where I got it from. When it was too late. No one wants to have their gallbladder removed or even think about having to get surgery.

I have been on NuvaRing for 4 months. I was previously on DepoProvera for 10 years, but due to bone loss, osteopenia, had to get off it. I had no side effects with Depo, no periods, no PMS, no problems.
I gained 12 pounds the first 2 months on NR. My weight continues to climb, even though I exercise and eat well. My breasts are swollen and sore constantly. I have excessive discharge, itchiness, and burning. I have also noticed I have gas more often.
I do not take the ring out for a week for a period, I just insert a new ring after 3 weeks and have experienced no bleeding. I have NOT experienced any of the other symptoms, such as depression, anxiety, mood swings, headaches, which is surprising since I have been estrogen-deficient for 10years and am suddenly on it.
Overall, my symptoms seem minimal compared to others' experiences, so maybe everyone is different. But it does scare me that these symptoms are possible in the future.

PROS:
easy to use, convenient
only have to take it once/3 weeks
big boobs!
no period

CONS:
weight gain
breast soreness
yeast infections, itchiness
excessive discharge
gas
cost $35 every 3 weeks (my Depo was free)

I have confusion.Difficulty speaking certain words.Memory seems altered.I have been using the tablets of estradiol for almost a year My problems seem to be increasing in severity. I use this medication due to hysterectomy. I am 47 years old.I also wake up at night with horrible itching on legs.,ankles,knees.What do you think.Possible reaction?.

Although I am not a woman, my fiance is using nuvaring, and on her 2nd day, she's vomited 2 or 3 times. I went to a professional health web-site that listed the "COMMON" side effects of nuvaring, which are:

More common side effects may include:
Abdominal cramps, allergic rash, bloating, blood clots, breakthrough bleeding and spotting, breast secretions, change in menstrual flow, changes in the breast such as tenderness or enlargement, dark pigmentation of the skin, decreased milk production in nursing mothers, depression, emotional instability, gallbladder disease, headaches, heart attack, high blood pressure, intolerance to contact lenses, liver disease, liver tumors, migraine headaches, missed periods, nausea, problems with the ring, sinus inflammation, stroke, swelling, temporary infertility after discontinuing NuvaRing, upper respiratory tract infections, vaginal inflammation or discharge, vision problems, vomiting, weight gain or loss, yeast infections, yellow tint to the skin

These are DANGEROUS side effects. not to mention they're "common". i don't know what you girls must be going through, but I really don't want my fiance going through these things. she's always been really sensitive to medicine and changes in her medicine. I am not a gullible person and I'm usually pretty skeptical when it comes to things like this, but I honestly do not think that NuvaRing is a stable product. As one other girl on here mentioned, my fiance recieved a sample and prescription for it. we read through literally EVERYTHING she received, NO side effects listed *whatsoever* She's already had problems in the past with depression, this is really the last thing she needs.

This is more of a vent. sorry to waste space, but people need to know what they're putting in their bodies.

If this WAS a safe product, they would freely and openly tell the people they're handing these rings out to, the common side effects. BUT if they did that, no one would buy this thing. It seems more like quick release of a new product without proper testing.

Stay SAFE! just because a doctor gives it to you, doesn't mean its safe.

SIDE EFFECTS OF YASMIN AS NOTED ON THE INISERT THAT COMES WITH THE PRESCRIPTION:
Nausea
vomiting
headache
diarrhea
bleeding between menstrual periods (spotting)
weight gain
acne
stomach cramps
rash
swelling or bloating
skin spots
breast tenderness
or difficulty wearing contact lenses may occur.

If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur:
dizziness
flu-like symptoms (e.g., fever, cough, unusual weakness/fatigue, sore throat, muscle aches)
mental/mood changes
trouble sleeping
hair loss
vaginal infections.

Tell your doctor immediately if any of these unlikely but serious side effects occur:
severe headache
pain in the lower legs or groin
trouble breathing
chest pain
vision changes
severe stomach pain
one-sided weakness
yellowing eyes or skin
lumps in the breast.

If you notice any other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of:
heart problems
stroke
gallbladder disease
diabetes
high cholesterol or triglyceride levels
high blood pressure
migraines
seizures
irregular vaginal bleeding
depression
any allergies.

This medication is not recommended for use if you have the following medical conditions:
liver problems
kidney or adrenal gland problems
history of blood clots (thrombophlebitis)
blood vessel problems (e.g., cerebral vascular disease, coronary artery disease)
history of certain cancers (especially endometrial or breast cancer)
heavy smoking (especially if older than 35 years of age).
If you are near-sighted or wear contact lenses you may develop vision problems or have trouble wearing your contact lenses.

Contact your eye doctor if this occurs. If you stop taking this birth control medicine and want to become pregnant, it may take a longer time than is usually seen with women not taking birth control medicine. Consult your doctor.

Do not smoke cigarettes. Birth control pills combined with smoking cigarettes, especially in women older than 35 years of age, puts you at a much higher risk of developing serious health problems than with birth control pills alone. Consult your doctor or pharmacist for more information.

If you will be having surgery, be confined to a chair or bed for a long period of time (e.g., a long plane flight), or have recently delivered a baby, notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk and has had undesirable effects on nursing infants. Consult your doctor before breast- feeding.

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

I have a hair thinning problem on just the top of my head. Also my hair has gotten very dry and brittle breaking off when I comb or brush my hair or even run my hands through my hair. It has become "frizz city".

I first started using vagifem a year ago. it stated inthe crimp inside the box that this stuff could cause gallbladder disease and dizziness. well i now have both of these side effects. i,m getting my gallbladder removed soon. i also have been on advair for my asthma for 2 years. when i visited the effects on the advair forum on this site i was shocked to learn that this medication ALSO causes gallbladder disease and a host of other things. if you take advair please visit that forum.