Bayer’s Birth Control Pills Still Under Fire

Once considered to be a promising birth control option for women, Bayer’s popular drugs, Yaz, Yasmin and Ocella have since fallen under intense scrutiny and remain a major subject of concern among the U.S. Food and Drug Administration, as well as within pharmaceutical advocacy groups like the U.S. Drug Watchdog.

While it is understood that the formation of blood clots is a potential side effect for women taking any form of birth control, four major studies have now proven that women taking Yaz, Yasmin and Ocella are 2 to 3 times more likely to develop clots, compared to women taking older generation, non-drospirenone containing pills.

The U.S. Drug Watchdog has declared that educating women regarding the harmful side effects associated with the use of Yaz, Yasmin and Ocella has become their “most important women’s health initiative ever.” The group is encouraging those who have suffered or have a loved-one who has suffered from stroke, heart attack, deep vein thrombosis, pulmonary embolism or even sudden death while taking these drug therapies to come forward.

Even more alarming, many women are being prescribed these particular medications for purposes other than birth control. For example, some women are given the drugs as a treatment for acne or as a reliever of PMDD symptoms. None of these drugs have been FDA approved for use as a treatment for either of these conditions.

In fact, as a response to such concerns, the FDA has commissioned a study of 800,000 American women currently using oral contraceptives in order to accurately assess the real danger associated with use of these drugs.

Health Canada Announces Safety Review of Yaz and Yasmin

Health Canada is currently reviewing the safety of Bayer Pharmaceutical’s birth control pills, Yaz and Yasmin, in an effort to determine if women who use these drugs are at an increased risk of developing life-threatening blood clots over women using different brands of birth control.

The review was prompted by two new studies recently published in the British Medical Journal, which concluded that women ages 15-44 taking birth control pills containing the synthetic progestin, drospirenone, are more likely to develop blood clots deep in the veins of the leg (venous thromboembolism), than women using birth control pills containing the common progestin levonorgestrel. The studies reported that the risk of developing blood clots for women taking the drospirenone-containing pills may be two to three times greater than those who take other pills.

Health Canada released a statement asserting that the agency is “currently evaluating the recently published studies and is looking at all available information to fully assess the risk of blood clots.” The agency also added that it will “take appropriate action as necessary once the review is complete.”

The U.S. Food and Drug Administration announced that it is also reviewing results from the British Medical Journal’s newly published studies but made certain to indicate that a more detailed evaluation of the studies’ conflicting results is required before the level of risk can be fully assessed.

Women currently taking birth control pills are urged to consult their doctors regarding any questions or concerns they may have about their prescribed oral contraceptive. Additionally, patients taking birth control pills should remain acutely aware of any signs or symptoms of a blood clot, including, persistent swelling in the leg, pain or tenderness in the lower leg, shortness of breath, and/or chest pain. Patients experiencing these symptoms are instructed to seek immediate medical attention.

FDA Announces Safety Review of Birth Control Pills

The U.S. Food and Drug Administration announced recently that it will conduct a safety review of birth control pills that contain the progestin hormone, drospirenone. The review was prompted by the findings of two published studies which assert that women taking birth control pills containing drospirenone may have an increased risk of developing blood clots.

Brand names of drospirenone-containing products include: Yaz (its generics, Gianvi and Loryna), Yasmin (its generics, Ocella, Syeda and Zarah), Beyaz and Safryral. While blood clots are a potential side effect of all birth control pills, the data from the two new reports caused the FDA to state, “This risk is reported to be up to two to three times greater than the risk of thromboembolism associated with using levonorgestrel-containing pills.”

The FDA’s safety review will involve more than 800,000 U.S. women and results are expected later this summer.

US Drug Watchdog Expands Its Yaz Yasmin Birth Control Pill Investigation

The US Drug Watchdog, a private advocacy group in the United States for victims of dangerous pharmaceuticals and medical devices, announced recently that it is expanding its ongoing national investigation of the birth control pills called Yaz, Yasmin and the generic version, Ocella, over concern surrounding the potentially serious side effects associated with use of the drugs, such as heart attacks, blood clots, strokes and other health risks. The group has proclaimed this issue to be one of the most important women’s health initiatives ever and remains committed to educating women regarding all of the risks linked to the use of these drugs.

Mother of Yaz Victim Files Suit Against Drug Company

Joan Cummins, mother of Michelle Pfleger, the Elon University freshman who died suddenly last fall as a result of a blood clot in her lungs, has filed a wrongful death suit against the drug manufacturer, Bayer Corp. The suit targets the company’s birth control product, Yaz, which Pfleger consumed between September 2009 and September 2010 and alleges that Bayer and its partners concealed the dangers associated with use of their drug, failed to properly warn consumers of these dangers and ultimately misrepresented the drug and violated consumer protection laws.

The class-action lawsuit further cites that the specially formulated progestin in Yasmin, Yaz and its generic counterparts is potentially fatal. The drugs, which have been linked to at least 50 reported deaths between 2004 and 2008, may potentially be responsible for “10 to 100 times more” deaths than those which were previously reported.

Plaintiffs are asking for a jury trial, damages, as well as coverage of the cost of the suit.

Yaz & Yasmin Related Deaths in USA

After a thorough search of the FDA’s adverse events database, a German research group found there have been 190 Yaz or Yasmin related deaths in the United States alone.

Most of the women were young and healthy when they started taking the oral contraceptive. They then suddenly developed blood clots, pulmonary embolisms, suffered a stroke or gallbladder disease.

Currently, there are about 7000 lawsuits against Bayer, the makers of Yaz and Yasmin. The German research group called Coalition against Bayer Dangers, or CBG would like to have women who suffered a Yaz side effect speak out at a Bayer shareholder meeting; Because of the high number of injuries, CBG aims to ask the drug makers to recall their best-selling birth control pill.

College Freshman Dies While on Yaz

Last September, an 18 year old college freshman at Elon University in North Carolina, collapsed as she walked to her morning class. She was healthy, except for a recent knee injury and had been taking the popular birth control, Yaz. There was no obvious reason for the collapse.  “She was pronounced dead a short time later at a nearby hospital… the Chief Medical Examiner attributed her death to a pulmonary thromboemboli, or obstruction of a blood vessel in the lung.”  (leighvalleylive.com)

Her mother believes that the oral contraceptive, Yaz, was to blame. The previous April the FDA required Bayer to “updated its labels for Yaz and Yasmin to warn of “the relative risk of developing venous thrombosis,” or blockage in a vein.”  The mother has sought legal counsel and is suing Bayer, the makers of Yaz.

She hopes to see justice for her daughter, and wants other women and teens to know about the dangerous side effects.

Study Shows Risk of Blood Clots

Bayer HealthCare Pharmaceuticals worked with the FDA to update the prescribing Information for YAZ after the interim results of a safety study revealed that a woman’s risk of developing blood clots is greatest during the first six months of taking a birth control prescription. “This risk is greatest when first starting the Pill and when restarting the same or a different Pill after a four week or greater break.” (PR Newswire.com)

The information comes from the ongoing, “Long-Term Active Surveillance Study for Oral Contraceptives,” an international study that collects data, and performs follow up on women taking birth control.

Many young women across the US have suffered blood clots of the leg and/or lungs after taking YAZ. Lawsuits against Bayer suggest that these dangerous side effects are more common and frequent with YAZ than with other birth control pills

New Study on Teens & Birth Control

The number of teenagers taking birth control has steadily risen since 2002. According to a new study by Thomson Reuters 18% teenage women ages 13 to 18 filled prescriptions for oral contraceptives in 2009.

“The number of commercially insured teens filling birth control prescriptions from 2002 to 2009 increased 63 percent.” (foxnews.com)

By far the most popular choice is Yaz, made by Bayer.

The increasing number of teens on Yaz may cause some concern as there are a growing number of lawsuits across the country from women and families of women who been harmed by the prescription.  The lawsuits claim that dangerous side effects–such as blood clots in the legs or lungs, hypertension, and stroke– are more common with Yaz than other oral contraception pills.

Yaz in the News

Pharma News Online reports that Bayer, the German company that makes Yaz birth control, has seen an increase in sales for 2010– 35.1 billion euros, up 13% from the prior year. This is their highest sales record in the company’s history. The article went on to note that growth was “dragged down by sales in North America, hit by generic competition for the YAZ.” It did not mention the more than 1000 US lawsuits filed against Bayer. Users of Yaz contraception involved in the lawsuits have developed serious and life threatening side effects. Certainly, all birth control prescriptions carry a risk of side effects. However, it’s believed that the risk of developing side effects is greater when taking Yaz, and that Bayer knew or should have known that.