Yaz Trial Delayed

The first Yasmin/Yaz trial involving a woman who suffered a pulmonary embolism after taking the birth control pill scheduled to begin next week has been delayed by Judge Herndon, the federal judge presiding over thousands of lawsuits. In an order issued December 31, Judge Herndon indefinitely continued the start of that case and ordered the parties to meet with a special mediator in an attempt to negotiate a settlement for the litigation.

Judge Herndon determined that the best interests of the litigation will be better served by delaying the start of the bellwether trial, which was designed to help the parties gauge how juries are likely to respond to evidence that will be presented in many of the cases. He appointed Professor Stephen Saltzburg of George Washington School of Law to serve as Special Master for purposes of mediating the entire litigation. The leadership teams for the plaintiffs and Bayer were ordered to meet with Saltzburg and to negotiate in good faith. Professor Saltzburg was recently the mediator that helped reach settlements in thousands of lawsuits over the side effects of Seroquel; an antipsychotic by AstraZeneca which many say causes diabetes and weight gain. In July, AstraZeneca reported it had reached settlements in more than 28,000 of those claims.

Over 10,000 women have filed a lawsuit against Bayer alleging that they suffered injuries as a result of the drug maker’s failure to adequately warn about the side effects of Yaz, Yasmin and other drosperinone-based birth control pills made by Bayer. Drospirenone is a newer type of progestin that is used in combination oral contraceptives that also include estrogen.

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Testosterone Treatment Lawsuits

Testosterone Lawyers Girard Gibbs Danko Law Firm

Girard Gibbs LLP represents clients who suffered heart attacks, blood clots, strokes, or other serious side effects after taking prescription testosterone supplements. The testosterone lawsuit investigation follows the publication of two studies linking testosterone replacement therapy (TRT) with increased cardiovascular risks. On January 31, 2014, the Food and Drug Administration released a Drug Safety Communication which states the FDA will reassess the safety of FDA-approved testosterone products.

Millions of men in the United States have been prescribed testosterone supplements to treat low testosterone, or Low T, a condition marked by low levels of testosterone in the blood that can cause side effects like decreased sex drive, low energy, weight gain, and moodiness. AndroGel, the most commonly prescribed drug in TRT, surpassed Viagra in popularity in 2012. In 2012, drug makers spent approximately $107 million dollars marketing testosterone products to potential consumers. Additional testosterone prescription medications include:

  • Axiron
  • Androderm
  • Bio-T-Gel
  • Delatestryl
  • Depo-Testosterone
  • Forestra
  • Striant
  • Testim
  • Testopel

If you or a loved one has used or is currently using testosterone supplements, our testosterone lawyers are interested in speaking with you. For a free, confidential consultation, call toll-free (866) 981-4800 or fill out the form to the right.

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Pfizer Recalls One Million Packs of Birth Control Pills

On January 31, 2012, the FDA posted a safety recall of one million packs of oral contraceptive pills because the pills may not be effective in preventing pregnancy. The recall covers Pfizer birth control Lo/Ovral-28 and generic versions of the drug (Norgestrel and Ethinyl Estradiol) with expiration dates between July 2013 and March 2014. Recalled pills may be labeled under the Akrimax Pharmaceuticals brand. Exact lot numbers for the recalled products are available on the FDA Safety Recall website.

According to Pfizer, the problem was caused by both mechanical and visual inspection failures on the packaging line which caused pills to be packaged out of order. Generally, birth control packets contain three weeks of contraceptive pills that contain hormones followed by a week of sugar pills that do not contain hormones. As a result of the packaging defect, some pill packs contained too many sugar pills and the pills that contained Norgestrel and Ethinyl Estradiol were placed at the wrong point of the cycle to effectively prevent pregnancy. The FDA recommends that consumers return the recalled products to the pharmacy where they were purchased.

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Current Yasmin and Yaz Label Warnings Are Inadequate

Seated around a U-shaped configuration of tables sat the 26 member FDA Advisory Committee — all scientists or physicians gathered to discuss the risks of birth control pills containing DRSP. They focused on the risks as described in recent studies, including the FDA’s own study that looked at over 800,000 women during a six year time period. The results of the FDA study concluded that new users of Yasmin may be twice as likely to experience a blood clot as users of other birth control pills containing the progestin Levonorgestrel.

During the first two hours of the hearing, an FDA representative presented an overview of the studies Bayer conducted after Yasmin was introduced to the market. The Bayer studies suggested that Yaz posed little additional risk. Then an FDA-paid scientist presented the results of the study that she conducted, showing a greater risk. But rather than bolstering her results with the six independent studies also showing a greater risk, the FDA-paid scientist gave those other studies – including those done by Drs. Jick of the U.S., Parkin of the U.K. ,Vlieg from the Netherlands and Lidegaard of Denmark– short shrift. Rather she focused on trying to explain away the conflicting results between the FDA’s own study and the Bayer-sponsored studies. Possible explanations she offered: FDA study design weaknesses and channeling. (Channeling is the selective prescribing of Yasmin to high-risk patients such as women with polycystic ovary syndrome.)

The FDA teed up nicely the topics for more than two hours of presentations by the German- owned Bayer representatives. Flanked by more than thirty Bayer suits seated neatly in five rows, Bayer’s vice president of US Medical Affairs, Leo Pouffle, with his stunted German accent led the charge. A regimen of six head-set tethered technicians each peering over his or her laptop supplied Dr. Poufle and other Bayer speakers with plenty of power-point ammunition. Bayer’s well-rehearsed battalion calmly, courteously and methodically casted doubt on the FDA study.

Members of the public were then allowed to speak. Each was limited to three minutes. Family members of Yaz victims described how Bayer robbed them of their young, fit, active healthy daughters who died after suffering a pulmonary embolism – caused by taking Yasmin or Yaz. Members of other women’s health organizations spoke up about the unnecessary health risks posed by DRSP. Two scientists testified, including Bert Gerstman, an epidemiologist who criticized the design of Bayer’s studies. Unfortunately, the public comment had little effect on today’s outcome.

After two more hours of questions and answers about the studies, the FDA advisory committee decided that Bayer’s current labels do not adequately reflect the risk/benefit profile for these products. That was expected, since the results of the FDAs own study are not described in the current warnings. But to the disappointment of consumer advocates, the committee did not push for black box or even tougher warnings. The members merely recommended that the FDA draft simpler warnings with an updated summary of recent conflicting study results.

One FDA committee member pressed Bayer’s vice president of US Medical Affairs on whether Yasmin and Yaz are more effective than other oral contraceptives at preventing pregnancy. If the drug was more effective, that might justify their higher level of risk. Dr. Plouffe deflected the question twice. But when the committee asked a third time, he admitted that Yasmin and Yaz are no more effective that other combination oral contraceptives.

Nonetheless, the committee voted 15 to 11 that the benefits of Bayer’s DRSP-containing oral contraceptives outweigh their risks. Apparently, some committee members, mostly clinicians, needed no evidence that Yasmin and Yaz are more effective than other oral contraceptives to come to that conclusion. They were satisfied that Yasmin and Yaz are as effective as other oral contraceptives at preventing birth and refused to accept reported results that Yasmin and Yaz pose greater risks of VTE than other birth control pills. More sympathetic to the consumer’s plight, the scientist and epidemiologists on the committee were dissatisfied with Bayer’s studies and offered their opinions that Yaz and Yasmin posed risks that were simply unacceptable.

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New Dutch Study Shows Yaz has Greater VTE Risk

Yaz & Venous ThrombosisA Dutch research team has published a new study concluding that Yaz has a greater risk of causing blood clots than other birth control pills.

The Dutch cohort study looked at over one million women from 2001-2008. Researchers confirmed nearly 3000 venous thrombotic events (VTEs), or blood clots, during that time frame. This was a follow up to their 2009 publication that was widely criticized by Bayer’s scientists. This study confirmed other studies which have shown:

• Birth control pills carry an increased risk of venous thrombosis (VTE).
• The risk was higher with some pills including Yaz than with other, safer “second generation” pills.
• Results on the risk from Yaz have been conflicting; but 4/6 studies have found an increased risk.

What this study adds to the previously published studies:

• Women using Yaz are at similar risk of VTE to those using oral contraceptives with the progestogens: desogestrel, gestodene, or cyproterone.
• Women using Yaz are at a higher risk than those using oral contraceptives with the progestogen, levonorgestrel.
• The risk of VTE was not reduced by using Yaz with 20 μg estrogen instead of Yasmin with 30 μg estrogen.
• To prevent one event of VTE in one year about 2000 women should shift from using oral contraceptives with desogestrel, gestodene, or drospirenone to those with levonorgestrel.

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More Evidence that Yaz carries an increased risk of VTE

 

The FDA posted the results of its much anticipated large retrospective study about the risk of venous thrombotic events (VTEs) and  newer contraceptives containing drosperinone (DRSP)  such as Yasmin, Yaz and Beyaz.

The FDA reports “In adjusted analyses, DRSP was associated with a significantly higher risk of VTE (venous thrombotic events) relative to low-estrogen comparators such as levonorgestrol with estimates of relative risk of 1.74 (95% CI 1.42 – 2.14)”.

The FDA acknowledged that the majority of previous epidemiological studies (4 of 6), all conducted retrospectively, demonstrate an increased risk of VTE with the use of DRSP-containing contraceptives suggesting that this association may be real.

According to the FDA, this study “provides another positive finding to the increasing body of evidence linking DRSP to increased risk of VTE” when compared to standard birth control pills.

With these results and the other “positive findings”, what will the FDA do?  That discussion has been reserved for the FDA meeting on December 8, 2011.

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FDA Safety Committees will examine the risks of Yasmin/Yaz/Beyaz as compared to levonorgestrel birth control pills.

Two FDA Safety Committees will hold public meetings about the risks of Yaz on December 8, 2011. The two committees to meet are (1) the 13-member Reproductive Health Drugs Advisory Committee and (2) the 13-member Drug Safety and Risk Management Advisory Committee.

The Safety Committee is comprised of experts in obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics and related specialties.  The Risk Management Committee is comprised of experts in risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug abuse.

The agenda: “to discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel.” The FDA intends to post the background material on its website no later than December 6, two days prior to the meeting.  If it is unable to post the material prior to the meeting, the materials will be available at the meeting, which will be held in the ballroom of the Marriott Inn at the University of Maryland.

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FDA Remains Inconclusive Regarding Drospirenone Study Results

FDA drospirenone studyThe FDA has communicated a luke warm statement about the safety of birth control pills containing drospirenone, stating that it “has not yet reached a conclusion and remains concerned.”

Consumers continue to await the final results of the FDA-funded study of the risks of drospirenone-containing birth control pills such as Yasmin, Yaz, and Beyaz. But the FDA says that preliminary results suggest an approximately 1.5 fold increase in the risk of blood clots for women who use those pills when compared to users of “other hormonal contraceptives”.

A joint meeting to discuss the risks and benefits with other safety committees is scheduled on December 8, 2011. At that time the final results of the FDA study should be released. Consumers anxiously await a full report of the study to determine whether it is consistent with findings earlier this year of a 2-4 fold risk of blood clots compared to users of second generation oral contraceptives.

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Yaz Lawyers File Lawsuit Against Manufacturers of Diabetes Drug Actos

Actos Lawyers Once again, drug manufacturers have failed to warn patients and their doctors about the dangers and risks associated with a pharmaceutical drug. This time it is the manufacturers of the diabetes drug Actos who are in hot water after studies showed that use of the drug for over 12 months was linked to an increased risk of bladder cancer. There was no mention of the increased risk in the original product labeling or package inserts.

Drug manufacturers need to adequately warn doctors and patients about ALL risks and benefits of a medication so that they can make an informed choice when choosing a drug to meet their needs.

We have spoken with hundreds of concerned Actos users who were kept in the dark about the dangers associated with Actos and we filed a lawsuit against Takeda Pharmaceutical Company on behalf of an individual who contracted bladder cancer while using Actos. If you or someone you know has taken Actos and contracted bladder cancer have them contact one of our Actos lawyers toll-free at (866) 981-4800 for more information.

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Yet Another Government Yaz Safety Investigation

Yaz Canada StudyEarlier we told you about the new investigation of Yaz and Yasmin by the Food and Drug Administration (FDA). Canada is now joining the United States and Europe in taking a closer look at drospirenone products such as the birth control pills Yaz and Yasmin. On June 7, 2011, Health Canada announced their own safety review. The Canadian report, available here, states:

Health Canada is informing health professionals and consumers, particularly women, that it is conducting an ongoing safety review of drospirenone-containing oral contraceptives to evaluate the potential for an increased risk of venous thromboembolism (VTE, which are blood clots) relative to other birth control pills.

According to the report, Yaz and Yasmin are the only two drospirenone containing birth control pills marketed in Canada. The studies that triggered the FDA and Health Canada investigations suggest that the clot-related risks associated with Yaz and Yasmin are “two to three times greater” than other pills on the market that use a different progestin. A higher risk of blood clots also increases your chance of suffering a pulmonary embolism or stroke, which could be deadly.

Thousands of women across North America have already learned about the connection between blood clots and Yaz the hard way. The Canadian report suggests that appropriate action “could include informing health professionals and Canadians of new safety information.” If you were taking a pill with two to three times the risk of other available pills, wouldn’t you want to know?

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