On October 10, 2008 the FDA released a warning letter to Bayer Healthcare, the manufacturer of YAZ and YASMIN, demanding that the manufacturer pull their television ads off the air.

 

The FDA found that the commercials mislead women into believing that YAZ and the generic brand, Ocella, can safely treat symptoms and ailments the medication was not approved to treat. The commercials state that use of YAZ and YASMIN can:

• eliminate PMS (premenstrual syndrome)

• be used solely as a medication to clear up acne in women

YAZ and YASMIN have been approved by the FDA for the prevention of pregnancy, for the treatment of premenstrual dysphoric disorder (PMDD), and for the treatment of moderate acne in women at least 14 years of age. The drug is approved to treat acne in women only if the patient desires an oral contraceptive for birth control. It is not approved as an acne treatment alone.

These ADS are MISLEADING because they broaden the drug’s indication, overstate the efficacy of YAZ and YASMIN, and minimize the serious risks associated with the use of the drugs.

These commercials encourage the use of YAZ and YASMIN in circumstances other than those for which the drug has been approved, over-promise the benefits, and minimize the risks associated with taking YAZ and YASMIN.

YAZ and YASMIN differ from most birth controls in the use of the progestin hormone, Drosperinone. Medical studies of Drosperinone have linked it to DANGEROUS side effects. Progestin can cause elevated potassium levels in women, leading to irregular heart rhythms, potentially leading to abnormal heart function death.

The risks associated with use of YAZ\YASMIN are:

• deep vein thrombosis (blood clots)

• pulmonary embolism

• strokes

• heart attack

You should not take YAZ, YASMIN or OCELLA if you have:

• uncontrolled high blood pressure, migraine headaches, or a heart valve disorder

• a history of stroke, blood clot, or circulation problems of diabetes

• kidney or liver disease

• adrenal gland disorder

• unusual vaginal bleeding

• any type of breast, uterine, or hormone-dependent cancer

• a history of jaundice caused by birth control pills

YAZ can also cause birth defects.

OCELLA is marketed as the generic form of the recalled YAZ birth control pill and has the same indications and side effects as YAZ and YASMIN.

Any woman taking Ocella should be informed of all possible risk factors.

If you or someone that you know has been injured, or worse, as a result of using YAZ, YASMIN or OCELLA, please contact the law offices of Houssiere, Durant & Houssiere, LLP to set up a free consultation with an attorney and medical expert. The attorneys and medical staff at Houssiere Durant and Houssiere, LLP have decades of experience in bringing successful suits against pharmaceutical companies who market dangerous and defective drugs.