The most recent warning to Bayer by the FDA concerns its use of sponsored links in internet search engines such as Google. The FDA has warned the makers of Yaz and Yasmin in the past about misleading television commercials that overstated how well the drugs worked and failed to properly inform women of the risks.

In March of 2009, the FDA sent a warning letter to Bayer stating that the use of the sponsored links was misleading in three ways:

• The sponsored links made suggestions and/or representations about how well Yaz worked but failed to state the risks.
• The sponsored links failed to indicate what conditions Yaz was approved to treat.
• The sponsored links failed to use the required established name of Yaz, which made the drug misbranded under the Food, Drug and Cosmetic Act and FDA regulations.

The FDA stated in its letter to Bayer that for promotional materials, such as sponsored links, to be truthful and non-misleading, they must state risk information to qualify any claims made about the drug in the link. The FDA actions resulted in Bayer discontinuing the sponsored links. The objectionable links appeared in this form:

YAZ® Birth Control Pill www.Yaz-US.com YAZ® Prevents Pregnancy, May Help Moderate Acne and PMDD.

According to the FDA, the sponsored links were inaccurate marketing of Yaz because the failure to list the risk information improperly gave the impression that Yaz was safer than has been demonstrated.

Sources:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM143477.pdf

http://m.industry.bnet.com/pharma/10001009/why-the-bayer-yaz-settlement-will-not-change-drug-advertising-forever/

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

One of the reported Yaz side effects is developing breast lumps. One of the most common types of breast lumps is a fibroadenoma, a benign, usually painless tumor that feels firm, hard or rubbery and moves easily under the skin. They are made up of both the glandular and connective tissue in the breast. Birth control pills are also linked to benign, fluid-filled cysts.

What Causes Breast Lumps on Yaz?

Doctors believe fibroadenomas are related to the estrogen in birth control pills. Most are simple, with distinct borders and uniform-looking cells. Complex adenomas contain cysts, enlarged breast lobules or calcifications. These adenomas increase your risk of later developing breast cancer.

To diagnose an adenoma, your doctor will order a mammogram or ultrasound. If a lump is seen, your doctor will likely use fine-needle aspiration to determine what type of lump you have. There are three outcomes of this procedure:

• No Fluid: Likely a solid mass and an adenoma. Core-needle biopsy is usually performed next to rule out cancer.
• Bloody Fluid: Your doctor will have the fluid tested for abnormal cells.
• Non-Bloody Fluid: This is likely a cyst and draining it may alleviate the problem.

Treating Adenoma

Fibroadenomas tend to grow and change the shape of the breast. Your doctor may recommend a lumpectomy to surgically remove the tumor if it is large or if the biopsy shows abnormal cells. Patients who feel anxious about leaving a lump in their breast may also get surgery. Continued monitoring of adenomas left in the breast is necessary in case the tumor grows.

If you are taking Yaz it is important to conduct frequent self breast exams and report any lumps to your doctor right away.
Sources:

http://www.nlm.nih.gov/medlineplus/ency/article/003155.htm

http://www.mayoclinic.com/health/breast-lump/WO00031

http://www.mayoclinic.com/health/breast-cysts/DS01071/DSECTION=tests-and-diagnosis

With the tale of a Maryland girl who suffered severe blood clots that resulted in a dangerous pulmonary embolism, today’s Morning Edition covered Yaz and the side effects that many of the users of the medication have suffered. You can listen to the story here.

Take Action for Your Health and Legal Rights

If you’re experiencing any of the Yaz side effects, or even suspect you have medical issues caused by Yaz, Yasmin or Ocella, talk to your doctor and seek immediate medical attention. You may also be able to take legal action against the birth control manufacturer.

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/

The most common form of gallbladder removal surgery is called laparoscopic cholecystectomy. It has a shorter recovery time than the traditional cholecystectomy and minimizes hospital stays.

Surgery is usually indicated when gallbladder problems, like gallstones, cause symptoms. Gallstones can be caused by a number of factors, including medication like Yaz.

Laparoscopic cholecystectomy uses a thin, lighted tube called a laparoscope. Three or four small cuts are made in the abdomen. The tube is inserted into one of the incisions while other instruments go into the other cuts. In order to give the doctor room to work inside your abdominal cavity, air is pumped in to expand the belly. The bile duct and blood vessels leading to the gallbladder will be cut, then the organ will be removed. During the surgery, an x-ray called a cholangiogram is done. In this test, dye is squirted into the common bile duct. The dye helps the surgeon see if there are gallstones outside the gallbladder so they can be removed. The hospital stay for most people after this surgery is usually only a few hours.

Traditional gallbladder surgery requires a five to seven inch incision in the abdomen and requires a hospital stay of between two and six days. This procedure is usually done if the laparoscopic method cannot be performed safely.

Have you had gallstones while on Yaz?

Sources:

http://www.gallbladderattack.com/gallbladdersurgery.shtml

http://www.nlm.nih.gov/medlineplus/ency/article/002930.htm

http://www.nlm.nih.gov/medlineplus/ency/article/007371.htm

Many people are not aware that more women than men die of heart disease each year. For some reason, heart attack is thought of as a problem for men, not women. Knowing the risk factors for women and the unique signs and symptoms can save your life.
If you take birth control pills, including Yaz, Yasmin or Ocella, your risk of heart attack is increased. Knowing the unique warning signs of a heart attack in women is key to getting prompt treatment because severe chest pain doesn’t always occur in women and your heart attack symptoms may be misdiagnosed. Women are more likely than men to have neck, shoulder, upper back or abdominal discomfort instead of chest pain. Other symptoms of heart attack in women are:

• Shortness of breath
• Nausea or vomiting
• Sweating
• Lightheadedness or dizziness
• Unusual fatigue

One key to surviving a heart attack is to not delay getting treatment. Damage to your heart muscle is occurring with every minute you wait. Those around you may dismiss your complaints because they don’t know the signs of heart attack in women. You may even encounter emergency medical personnel who miss the signs. Speak up for yourself. You know when something is wrong.

Risk Factors More Significant for Women

The risk of heart disease in women is affected by high cholesterol, high blood pressure and obesity, just as it is for men. Some risk factors impact women more, like stress, depression and smoking. Women have the added risk factor of birth control pills. Discuss these special risk factors with your doctor and determine a plan for managing them.

Knowledge is the key to avoiding or surviving a heart attack. Knowing the signs can empower you to be heard by your physician, medical personnel and even your loved ones. Did you have a heart attack on Yaz? Are you worried about your risk?

Source:

http://www.mayoclinic.com/health/heart-disease/HB00040