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“Beyond Birth Control”: Yaz, the FDA, and Women’s Health

All over the internet, Yaz birth control complaints have been popping up on woman’s health boards, forums, and other social sites.  These range from rapid weight gain, vision problems, vulvodynia, worsening PMS symptoms, irregular bleeding, nausea, heart attacks, strokes, heart palpitations, headaches, back pain, chest pain, depression, and fatigue.

Many women know about Yaz and Yazmin, popular birth control pills manufactured by Bayer Healthcare International, advertised with cheerful balloon-filled commercials.  Yaz claims to cure acne, ease symptoms of PMDD (a condition marked by severe depression symptoms, irritability, and tension before menstruation), and banish depression, bloating, and a barrage of other monthly troubles that women deal with.  Their official claim states “Yaz is the only birth control proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life.

These commercials caused many women to take Yaz and then suffer from unpleasant side effects, injury, and in worst cases, death.  Other forms of birth control have side effects, as your doctor or Gynecologist is required to tell you before starting your prescription, but Yaz appears to be a special case, as it contains a hormone that has never been used in birth control before.  This hormone is known as drospirenone.

Drosperinone acts on the body as a diuretic and causes fluid loss, which in effect decreases sodium in the blood and increases potassium. This imbalance and high potassium levels causes irregular heartbeats and blood pooling, resulting in a high risk of heart attacks, blood clots, and in some cases stroke.

In response to Bayer’s misleading marketing and failure to properly disclose all possible health risks, the FDA, which approved Yaz in 2006 sent Bayer a warning letter, taking issue with ads implying that Yaz was approved to treat PMS symptoms, as the commercials described and the downplaying of risks associated with drospirenone.

Yaz was not in fact approved to treat PMS.  The FDA forced Bayer to remove many of their ads and develop a new $20 million advertising campaign discussing additional risks unique to Yaz (drospirenone) and informing the conditions Yaz is actually approved to treat, namely PMDD.  The symptoms of PMDD (Premenstrual dysphoric disorder) are similar to those of PMS, but they are generally more severe and debilitating.  Examples include feeling of sadness or hopelessness, suicidal thoughts, tension and anxiety, feeling out of control, food cravings or binge eating, and sleep disturbances.

Yaz ads had also originally stated that the increase of Potassium was a drug benefit, rather then a danger.  The FDA countered with the statement, “By failing to add the necessary context to clarify that increased blood potassium is a safety risk rather then a clinical benefit, the ad misleadingly represents or suggests that the drug is safer then has been demonstrated by substantial evidence or clinical experience.”

Bayer failed to warn consumers that the drug posed increased risk for serious injury, while promoting benefits Yaz didn’t offer (non-FDA approved uses).  Late 2008, the FDA made it known to Bayer that their ads were misleading and that additional risks had been proven, due to Yaz contraceptive’s unique ingredient, after receiving over fifty reports that Yaz and Yasmin had contributed to the death of women as young as 17. In 2002, the British Medical Journal reported that more then 40 cases of women developed DVT (Deep Vein Thrombosis) due to the drug.*

Despite the fact that injury claims are catching up with Bayer, they’ve neglected to withdraw the drug or take any serious actions to limit or address injuries related to Yaz.  Incredibly, Yaz is still Bayer’s best-selling pharmaceutical product group. In the beginning of 2009, Bayer’s sales totaled $443.2 million dollars for Yaz, approximately an 8% gain from the previous year.

Bayer continues to increase its profits at the expense of young women across the country, while downplaying any warnings.

Yasmin discloses:  “The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were present in all YAZ clinical trials included upper respiratory infection, headache, breast pain, vaginal moniliasis, nausea, abdominal pain, dysmenorrhea, urinary tract infection, accidental injury, sinusitis, and emotional lability.

Ladies, if you are on Yaz, be aware of the following symptoms:  numbness/weakness in the face, arms, legs, or on only one side of the body, vision problems, the sudden loss of coordination, balance, or spells of dizziness. More serious injuries include strokes, heart attacks Deep Vein Thrombosis(DVT), Pulmonary Embolism (PE), Cardiac Arrhythmias, Gallbladder disease, and sudden death*. Also, take note that Yaz is marketed under the generic name “Ocella”.

*Atkins & Markoff, “Defective Birth Control Pills, Yaz, Yasmin, and Ocella”.

* http://www.drugwatch.com/yaz/side-effects.php

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