LAWSUITS NEWS & LEGAL INFORMATION

Drospirenone FAQ

What is drospirenone?

Drospirenone, in combination with ethinyl estradiol, is used as an oral contraceptive in brand names such as Yasmin, Yaz and Ocella, the generic brand of Yasmin. It is a synthetic progesterone (female hormone), which other and traditional oral contraceptives do not contain. Drospirenone helps regulate ovulation and menstruation, while estradiol is a female hormone involved in development and maintenance of the female reproductive system.

What does fourth generation mean?

The progestin in Yaz and Yasmin is referred to as fourth generation because it’s the fourth reformulation of synthetic progesterone since the birth control pill was introduced in the 1960s.

Which birth control pills contain drospirenone?

Brand names of drospirenone-containing products include Yasmin (generics Ocella, Syeda and Zarah), Yaz (generics Gianvi and Loryna), Beyaz and Safyral.

How much drospirenone is in Yasmin and other birth control pills?

Yasmin (drospirenone/ethinyl estradiol) tablets consist of 28 film-coated tablets that contain 21 yellow tablets each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol ( EE). See rxlist.com for a detailed list of ingredients.

What serious side effects is drospirenone associated with?

Drospirenone is associated with serious side effects, including venous thromboembolism (VTE), deep vein thrombosis (DVT), pulmonary embolism, stroke and heart attack. It is also associated with gallbladder disease, particularly in young women.

How can drospirenone be associated with these life-threatening side effects?

Taking a medication containing drospirenone can stop the body from secreting hormones that regulate the body’s electrolytes and water, which in turn can cause an increase in bodily potassium level. This increase can lead to hyperkalemia. Extremely high levels of potassium in the blood can result in cardiac arrest and death.

It is already well documented that estrogen found in all forms of birth control pills increases blood clot risks.

Yaz causes gallbladder disease because it increases cholesterol levels in bile and decreases gallbladder movement. As a result, gallstones form, which are basically calcified cholesterol chunks, and the gallbladder becomes inflamed. This disease is not normally fatal, but treatment usually means a painful and costly surgery.

What side effects are attorneys investigating?

Attorneys are accepting Yasmin and Yaz injury claims involving deep vein thrombosis (DVT), heart attack and pulmonary embolism - a blockage in a lung artery.

Who makes birth control pills containing drospirenone?

Bayer makes Yasmin and Yaz and Ocella, the generic brand of Yasmin (marketed and distributed by Barr Laboratories).

When did the FDA approve drospirenone and were there any warnings at that time?

The FDA approved Yasmin in 2001 and Yaz in 2006. Bayer warned that Yasmin should not be used by women with kidney, liver or adrenal disease. More recently, researchers warn women not to take any birth control pill containing drospirenone who have coronary artery disease, cerebrovascular disease, uncontrolled hypertension, migraine headaches and abnormal uterine bleeding. Also, women who have or have had breast cancer and liver tumors should not use fourth-generation birth control pills.

Is the FDA warning users of drospirenone serious side effects?

Yes. As early as November 2009, the FDA had reports of 993 cases of pulmonary embolism, 487 cases of DVT and 229 cases of other blood clots for drospirenone and ethinyl estradiol combined.

In September of 2011, the FDA’s safety announcement indicated a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.

Three months later an FDA advisory panel voted to strengthen the warnings on drospirenone-containing birth control, namely to warn patients about the risk of blood clots associated with the contraceptives. However, the panel voted not to recall the birth control pills.

In January of 2012, the watchdog group Project on Governmental Oversight demanded that the FDA take a second look at its advisory committee, alleging at least four members had financial ties to Bayer.

For more information, visit the FDA safety information website.

Is drospirenone used off-label? For anything other than birth control?

Yes. It has also been used to treat the symptoms of menopause, moderate acne and osteoporosis.

What do studies say about drospirenone?

A number of studies suggest that women taking birth control pills containing drospirenone (or desogestrel and gestodene) have double the risk of venous thromboembolism (VTE) than women on pills containing an older progestogen (levonorgestrel).

In 2011, The British Medical Journal reported that Yaz and Yasmin containing drospirenone (DSRP) carry up to triple the risk of serious blood clots (known as venous thromboembolism) over traditional pills containing the progestin levonorgestrel (LNG).

At the end of 2011, The Canadian Medical Association Journal reported a study involving about 330,000 women in Israel, which found that women taking birth control pills containing drospirenone were as much as 65 percent more likely to develop venous thromboembolism than women taking older generations of the pill.

Have the makers of birth control pills containing drospirenone been accused of inappropriate marketing or false advertising?

Bayer has been accused of exaggerating benefits such as acne reduction and other benefits of the drugs’ uses in marketing and advertising campaigns, and downplaying the serious dangers associated with the drug.

In 2008, the FDA warned Bayer that its TV advertisements were misleading and did not disclose the additional risks.

Between 2007 and 2010, Bayer spent more than $270 million on advertising for Yaz. In 2009, however, the FDA told Bayer it needed to correct its marketing and advertising, particularly with its wild claims regarding Yaz. Bayer had to spend $20 million on new ads to correct its outrageous marketing and sales campaigns.

What else is Bayer accused of?

Bayer has also been accused of lack of research and failing to issue recalls on Yasmin and Yaz after reports showed a risk of life-threatening side effects. Lawsuits against Bayer include negligence, strict product liability, breach of express and implied warranties, fraudulent and negligent misrepresentation, fraudulent concealment, medical monitoring, and fraud and deceit.

Has Bayer settled any claims?

According to Bayer, as of March 2014, it had settled 8,250 cases for $1.7 billion. Bayer has only been settling claims in the US for venous clot injuries (deep vein thrombosis or pulmonary embolism).

Court documents show that Bayer agreed to pay up to $24 million to settle other lawsuits in the MDL involving gallbladder complaints. Attorneys have said these complaints will be settled after the above lawsuits have been settled.

What is happening with litigation? Can I still file a claim?

Although Bayer has settled many claims, attorneys are still accepting Yasmin complaints.

Yasmin lawsuits are still being filed and more cases are pending in state and federal courts nationwide.

Lawsuits filed in federal courts have been transferred to the U.S. District Court for the Southern District of Illinois. Because there are so many cases that have similar claims against common defendants, they have been consolidated into multidistrict litigation (MDL) where one judge will manage them for greater efficiency.

How much time do I have to file a lawsuit against Bayer?

States differ in their statute of limitations. Attorneys advise women who have suffered DVT, pulmonary embolism or heart attack or their families to inquire about drospirenone birth control lawsuit time limits sooner than later.