In October of 2008, the FDA admonished the manufacturer of Yaz for running misleading ads. One of the allegations was that the spots overstated the pill’s effectiveness.
The FDA said that the ads suggest that Yaz can eliminate acne. One ad featured a woman and the word “acne” prominently displayed on the screen, then fading away. The audio claims, “it can also help keep your skin clear.” Another ad shows a woman releasing a balloon marked “acne,” which disappears as the song “Goodbye To You” plays in the background. Clinical results indicate that Yaz merely reduces acne more than a placebo did.
Source:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf
All birth control pills containing estrogen present risks to a woman’s health. Estrogen has an effect on the body that can cause side effects and serious medical conditions, and older women should take birth control with the lowest dosage. Yaz, Yasmin and Ocella present an additional risk for women because of its progestin ingredient, drospirenone. Drospirenone raises blood potassium levels, which can lead to serious health risks including blood clots.
After the age of 35, the health risks of taking birth control pills in general increases because women are more likely to develop certain medical conditions the older they get. For instance, older women have a higher risk of blood clots and high blood pressure.
Some researchers believe that older women are at higher risk because they may lead a more sedentary lifestyle, may be more overweight, or may start smoking. In addition, those with a genetic predisposition may develop certain medical conditions as they get older.
Over the age of 35, some risk factors should make you seriously reconsider taking birth control pills. These risk factors include obesity, high blood pressure, diabetes and high cholesterol. Yaz and smoking is an extremely dangerous combination.
Are you over 35? Your doctor can discuss your risks of taking birth control pills such as Yaz.
Sources:
http://www.usnews.com/health/blogs/on-women/2009/1/13/should-you-stop-taking-birth-control-pills-if-youre-over-35
Before taking any medication or drug, you should ask your doctor or pharmacist to explain the meaning of a “boxed warning” or “black box warning” and whether the drug has one. A warning on drug labeling is called a “black box” warning because of the heavy, black line that surrounds the warning information.
The Food and Drug Administration (FDA) is the government agency responsible for regulating all prescription and nonprescription medication sold by companies in the U.S. Before approving a drug for use, the FDA determines if a medication has such health and safety risks that medical professionals and consumers should be warned in a bold manner on the packaging, prescribing information and/or package insert materials. If the FDA becomes aware of health and safety risks after a drug is on the market, they may also require that the drug maker add a boxed warning.
Yaz, Yasmin and Ocella contain the following “black box” warning:
Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.
Discuss the Yaz boxed warning and all Yaz side effects with your doctor prior to use.
Source
http://berlex.bayerhealthcare.com/html/products/pi/fhc/YAZ_PPI.pdf?WT.mc_id=www.berlex.com
http://www.healthcentral.com/asthma/c/962/20299/black-box-asthma
If you believe that you are experiencing a certain side effect from Yaz, doing a little research can give you some peace of mind. And while only a doctor can give you a definitive diagnosis, arming yourself with a little information can help you communicate your symptoms and concerns more effectively.
Web sites like Web MD and Mayo Clinic have tools that will help give you an idea of what might be causing your problem. You can plug in your symptoms and the sites will give you a list of some of the conditions that can cause those symptoms.
Sources:
http://symptoms.webmd.com/default.htm
http://mayoclinic.com/health/symptom-checker/DS00671
Women using the birth control pills Yaz, Yasmin and Ocella have reported a variety of side effects. The list of possible side effects from these drugs is lengthy. Some are quite common, some are reported less frequently, and some are rare. Refer to the YazTalk post that includes the entire list of Yaz symptoms.
If you are taking Yaz and are concerned, contact your doctor to discuss what you are experiencing. Some side effects are common to many birth control pills and subside in time. Others may be an inconvenience, but should not pose a serious risk to your health. Certain side effects are a sign of a serious, underlying medical condition that should be immediately treated.
Be prepared to discuss with your doctor when the Yasmin side effects began and their severity. You likely discussed your family medical history with your doctor prior to starting birth control pills. Update your medical history with any new information that may help your doctor decide if the side effects of Yaz indicate you should stop taking it.
Source:
http://www.sokolovelaw.com/yaztalk/2010/02/yasmin-side-effects-an-overview/
Women taking Yaz, Yasmin and Ocella are at increased risk of developing blood clots. Blood clots that develop in the deep veins of the legs, pelvis, or rarely the arms, are a serious side effect of Yaz called deep vein thrombosis (DVT). A life-threatening complication of DVT is pulmonary embolism, which occurs when part of the blood clot breaks loose and travels to the lungs.
When a DVT develops in one of the large veins in the legs, it can block the flow of blood and cause pain, swelling, warmth and sometimes red skin over the affected area. This inflammation caused by the clot is called thrombophlebitis. Never ignore pain in legs from Yaz.
Knowing the symptoms of deep vein thrombosis can save your life. Any pain in your legs while you are taking Yaz should be immediately evaluated by a doctor to rule out DVT.
Sources:
http://www.emedicinehealth.com/blood_clot_in_the_legs/article_em.htm#Leg%20Blood%20Clot%20Overview
http://www.webmd.com/dvt/deep-vein-thrombosis-pulmonary-embolism
Yaz and Yasmin are combined oral contraceptives, more commonly known as birth control pills. These drugs are similar in many ways, but they also have some important differences.
Yasmin is Introduced
Yasmin was approved by the FDA in 2001 to prevent pregnancy in women and also for the treatment of moderate acne and premenstrual dysmorphic disorder (PMDD) in women who also needed to prevent pregnancy. At the time, Yasmin was manufactured and marketed by Berlex.
Yaz is Introduced
In 2006, Bayer purchased Berlex and quickly introduced Yaz, which was approved for the treatment of moderate acne and premenstrual dysmorphic disorder (PMDD) in women also seeking birth control. Bayer continues to manufacture and distribute Yasmin.
Different Amounts of Estrogen
Yaz is referred to as low-dosage Yasmin. Both Yaz and Yasmin contain 3.0 mg of the progestin ingredient drospirenone. Yaz contains a smaller dosage of the estrogen ingredient ethinyl estradiol. Yaz contains 0.02 mg and Yasmin contains 0.03 mg.
Different Regimens
Yaz and Yasmin are also different from each other because of their regimen, or how they are taken. They both come in a 28-day supply. Yaz has 24 active pills, followed by 4 inert pills, while Yasmin has 21 active pills followed by 7 inert pills. This means that women taking Yaz receive three extra days of active hormones each month.
Are you taking one of these birth controls?
Source:
http://www.drugs.com/cons/yaz.html
All birth controls are different. They use different ingredients and dosages. While most combined oral contraceptives use the same estrogen ingredient, ethinyl estradiol, they use different amounts of estrogen and different types of synthetic progesterone.
When combination oral contraceptives were first developed to prevent pregnancy in women, they contained a much higher dosage of estrogen than is used in birth control pills today, combined with a progestin. The risk of stroke was very high in women taking birth control pills with a high dosage of estrogen. Over the years, different combinations of estrogen and progestin were developed in an attempt to decrease the risk of serious side effects.
The Newest Progestin, Drospirenone
Yaz, Yasmin and Ocella are known as fourth-generation birth controls because they use yet another type of progestin, drospirenone. The maker of Yaz touted this new birth control as revolutionary in that it would treat the symptoms of premenstrual dysmorphic disorder (PMDD) and moderate acne in women in addition to preventing pregnancy.
It quickly became evident that Yaz caused serious and life-threatening side effects in women. Studies have shown that drospirenone leads to a much greater chance of developing blood clots than other birth control pills.
Did you get seriously ill after taking Yaz, Yasmin or the generic Ocella?
Source:
http://women.webmd.com/features/comparing-birth-control-pill-types-combination-minipills-more
Berlex Laboratories, not Bayer, originally manufactured the birth control pill Yasmin. The Food and Drug Administration (FDA) approved Yasmin in 2001.
In 2003, the FDA sent Berlex a warning letter for running TV ads that were misleading and inaccurate. The commercials improperly implied that Yasmin was superior to other combined oral contraceptives on the market.
The FDA also warned Berlex that the commercials did not adequately inform women of the serious health risks of taking Yasmin and were unlawfully minimizing side effects of the drug. The FDA has warned for years about “the added clinical risks associated with drosperinone,” the progestin ingredient in Yasmin and Yaz.
The FDA ordered Berlex to stop running the ad because of the “significant public health and safety concerns” raised by the misleading commercials.
One of the allegations in the litigation against the makers of Yaz, Yasmin and Ocella, the generic form of Yasmin, is that many women began taking these drugs after seeing the inaccurate marketing on television over the years.
Are you one of the many women influenced by the deceptive advertising?
Source:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168914.pdf
If you are coughing up blood (hemoptysis), there could be several reasons. This could take different forms, like bright red or pink and frothy or combined with mucus.
There are several serious causes of coughing up blood, but the major cause is chronic bronchitis, a relatively minor and easily treatable condition. If you are coughing up blood and taking Yaz, don’t assume a benign cause is to blame, even if you have been sick with an upper respiratory disease.
A serious and life-threatening side effect of taking Yaz, Yasmin and Ocella is deep vein thrombosis (DVT), a blood clot in one of the deep veins of the lower extremities. A complication of DVT is pulmonary embolism, where part of the blood clot breaks free and travels (embolizes) to the lungs. The symptoms of pulmonary embolism are shortness of breath or difficulty breathing, sharp chest pain, general symptoms of anxiety, sweating, heart palpitations or fainting, and coughing up red or pink foam, froth or blood.
Coughing up blood should always be assessed by your doctor or by going to the emergency room.
Sources:
http://www.webmd.com/lung/tc/pulmonary-embolism-topic-overview?page=2
http://www.medicinenet.com/script/main/art.asp?articlekey=88679&page=4
http://www.mayoclinic.com/health/coughing-up-blood/MY01064/DSECTION=causes