Yaz Yasmin Beyaz Recall

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What is Beyaz and What’s Wrong With It?

Beyaz is a birth control pill manufactured by Bayer since September 24, 2010. Beyaz is the same as Yaz in that both drugs are combined oral contraceptives, or COC’s, containing estrogen (ethinyl estradiol) and progestin (drospirenone). Beyaz is indicated to prevent pregnancy with the addition of a daily dose of folate added to reduce the rate of neural tube deficits, like spina bifida, in pregnancies which occur during Beyaz use or shortly after stopping Beyaz. Beyaz is also indicated to treat premenstrual dysphoric disorder ( PMDD – but not premenstrual syndrome, PMS), as well as to treat moderate acne is women 14 years or older.

In April 2012, the FDA required Bayer to add a warning to the Beyaz label stating that women using Beyaz or drospirenone containing COC’s may be at an increased risk of suffering blood clots in the heart, lungs, brain or legs, known as VTE or venous thromboembolism. Combination pills may also increase the chance of suffering high blood pressure, gall bladder disease and liver tumors. Women who smoke and are over 35 years old, have kidney, liver or adrenal disease, should not use Beyaz. Women who have or have had blood clots, stroke or heart attack should not use Beyaz.

What is Yaz?

Yaz or Yasmin is a birth control pill which has been associated with medical problems including heart attack, cardiac arrhythmia, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, gallbladder disease, hepatic adenomas and sudden death.

Ocella, the generic equivalence of Yaz or Yasmin contains ethinyl estradiol and progestin drospirenone (DRSP). Drospirenone is already well-known for increasing the risk of hyperkalemia. In addition the Food and Drug Administration has also associated DRSP oral contraceptives with adverse reactions including: blood clots, deep vein thrombosis (DVT), pulmonary emoblism (PE), stroke, cerebrovasular accidents, heart attack, myocardial infraction, gallbladder disease, gallbladder removal (cholecstectomy), kidney failure or renal failures, pancreatitis and even death.

What makes Yaz, Yasmin and Ocella so different from other birth control pills?

All brit control options are associated with health risks, especially for females over 35-years of age who smoke cigarettes. However, the oral contraceptive pill Yaz, Yasmin and Ocella have the distinction of being associated with a potentially higher risk of blood clots. Serious side effects like stroke, heart attack, pulmonary embolism, as well as deep vein thrombosis are all risk factors of blood clots.

Bayer HealthCare Pharmaceuticals, Inc., the manufacturer of Yaz, Yasmin and Ocella has received numerous warning letters from the U.S. Food and Drug Administration concerning their misleading advertisement and container testing at their plants.

In 2009, Bayer HealthCare Pharmaceuticals, Inc. was required by the Food and Drug Administration warning letter to sponsor a $20 million advertising campaign to correct previous Yaz advertisement that overstated the benefits and understated the risks of brit control pill.

If you or your loved one has suffered serious side effects or injury from using the birth control pill Yaz/Yasmin, contact us immediately for a free online or telephone consultation.

FDA panel urges warnings for Yaz, Yasmin; now what?

Dec 16, 2011, Consumer Reports

Well-known birth control pills such as Yaz and Yasmin need stronger warnings about the risk of blood clots, an FDA advisory committee reportedly recommended last week. This comes on the heels of the agency’s recently released analysis showing the drugs pose a greater risk of clots compared to older birth control pills. The FDA acknowledged that other studies have not found such an increase. With all the controversy, where does this leave women who take Yaz and related oral contraceptives?

Most birth control pills combine two types of hormones: estrogen and a progestin. Newer pills pair estrogen with the progestin drospirenone, a synthetic hormone that may minimize side effects such as fluid retention, breast tenderness, weight gain and increased blood pressure. Other drospirenone-containing pills include generic Gianvi, Loryna, Ocella, Syeda, Zarah, and Beyaz and Safyral. Some are also approved to treat moderate acne and premenstrual dysphoric disorder.

Use of any combination birth control pill increases the risk that a blood clot will form in a deep vein of the leg. But overall, that risk is relatively small: between 9 and 10 women in 10,000 per year, compared to about 0.5 to 3 women in 10,000 per year who do not take any birth control pills. However, if the clot breaks off, travels to the lungs and blocks blood flow, it can be deadly. These conditions are considered types of venous thromboembolism (VTE). Some studies have also linked certain progestins used in birth control pills to a higher risk of VTE.

But many of those studies had problems, according to both the FDA and an analysis of the evidence conducted for Consumer Reports by the American Society of Health-System Pharmacists. Most studies did not consider all risk factors the subjects may have had for VTE. Some failed to identify the types of pills used in the comparison group or confirm diagnoses of VTE. And many had too few cases of VTE to accurately assess differences in risk.

Although the absolute risk of VTE may be small and even debatable among medical professionals at this time, there are steps you can take now to reduce your exposure if you are concerned:

Talk to your doctor. If your birth control pill contains drospirenone, the FDA advises that you continue to use it unless told otherwise by your healthcare provider. If you’re considering using a drospirenone-containing pill, your doctor should weigh its risks and benefits in light of your personal risk for developing blood clots.

Address your risk factors. The risk of a blood clot with combination birth control pills is highest during the first year of use—especially in the first three months—and when you restart the pill after a break of four weeks or longer. But the more risk factors you have, the greater your risk. These include smoking, being obese or overweight, and health problems such as diabetes.

Stay active. Regular exercise such as walking improves circulation and reduces the risk of VTE. Move your legs often if you have to sit or lie down for an extended period of time.

Avoid the pill immediately after childbirth. The risk of VTE escalates in pregnant and postpartum women.

Know the symptoms of VTE. Seek medical attention immediately if you have swelling, pain, warmth, redness or discoloration of one leg, swollen-looking veins in the leg, or pain or tenderness in the calf muscle or groin. Symptoms of a clot in the lung include sudden shortness of breath, sharp chest pain, coughing up blood, and less commonly, dizziness, back pain or wheezing.

Bottom line: Serious blood clots are relatively rare in young women with limited risk factors. Recent trials report an increased risk of VTE with drospirenone-containing birth control pills compared with older versions of the pill, although the results of previous studies are conflicting. If you’re concerned, discuss risks and benefits with your doctor, and consider a pill or birth control method with a more consistent safety profile.

Thromboembolic Disorders and Other Vascular Problems Safety Labeling Changes Approved by FDA

March 2011, FDA

The risk of VTE is highest during the first year of use. Interim data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Interim data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.

Thromboembolic Disorders and Other Vascular Problems Safety Labeling Changes Approved by FDA

April 2010, FDA

Several studies have investigated the relative risks of thromboembolism in women using a different drospirenone-containing COC (Yasmin, which contains 0.030 mg of ethinyl estradiol and 3 mg of drospirenone) compared to those in women using COCs containing other progestins. Two prospective cohort studies, both evaluating the risk of venous and arterial thromboembolism and death, were initiated at the time of Yasmin approval. 1, 2 The first (EURAS) showed the risk of thromboembolism (particularly venous thromboembolism) and death in Yasmin users to be comparable to that of other oral contraceptive preparations, including those containing levonorgestrel (a so-called second generation COC). The second prospective cohort study (Ingenix) also showed a comparable risk of thromboembolism in Yasmin users compared to users of other COCs, including those containing levonorgestrel. In the second study, COC comparator groups were selected based on their having similar characteristics to those being prescribed Yasmin.

Two additional epidemiological studies, one case-control study (van Hylckama Vlieg et al. 3) and one retrospective cohort study (Lidegaard et al. 4) suggested that the risk of venous thromboembolism occurring in Yasmin users was higher than that for users of levonorgestrel containing COCs and lower than that for users of desogestrel/gestodene-containing COCs (socalled third generation COCs). In the case- control study, however, the number of Yasmin cases was very small (1.2% of all cases) making the risk estimates unreliable. The relative risk for Yasmin users in the retrospective cohort study was greater than that for users of other COC products when considering women who used the products for less than one year. However, these one-year estimates may not be reliable because the analysis may include women of varying risk levels. Among women who used the product for 1 to 4 years, the relative risk was similar for users of Yasmin to that for users of other COC products.

Warning Letter from FDA to Yaz Manufacturer Bayer

The Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed two direct-to-consumer television advertisements for Yaz or Yasmin (drospirenone and ethinyl estradiol) Tablets (YAZ) submitted by Bayer HealthCare Pharmaceuticals, Inc. (Bayer).

According to DDMAC, the TV ads were misleading because they broaden the drug’s indication, overstate the efficiency of Yaz, and minimize serious risk associated with the use of the drug. Thus, DDMAC finds that the commercials misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 352(n), 352(f)(1) & 321 (n), and FDA’s implementing regulations. 21 CFR 201.1 OO(c)(1); 201.128; 202.1 (e)(5)(iii) & (e)(6)(i).

It was found that these violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz.

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