Bayer Withheld Yasmin Data, Yasmin Lawyers Filing Lawsuits

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Bayer Withheld Yasmin Data From U.S., Former Agency Chief SaysDec. 6 (Bloomberg) — A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said.

David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didn't include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin's safety provided to the agency.

The report also didn't include an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said, quoting the draft.

“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said. The company also promoted the oral contraceptive for unapproved uses, particularly for treatment of premenstrual syndrome, Kessler said.

Kessler's report and four other expert opinions were released yesterday by lawyers representing former users of Bayer's Yasmin family of contraceptives. The experts were paid by the plaintiffs' lawyers, who submitted the reports to the FDA, which is considering safety findings on Yasmin and its sister product Yaz at a hearing Dec. 8.

‘Matters of Litigation'

Rose Talarico, a U.S.-based spokeswoman for Bayer, said the company doesn't comment on ongoing lawsuits. “We have nothing further to add as these are matters of litigation,” she said in an e-mailed statement. “We expect them to be addressed further at trial.”

Morgan Liscinsky, an FDA spokeswoman, didn't immediately comment on the unsealed documents about the drugmaker's handling of the contraceptives.

The FDA didn't accept the documents for the hearing, according to an e-mail sent to plaintiffs' lawyer Ned McWilliams late yesterday.

“The deadline for all written submissions was on November 23, 2011,” Kalyani Bhatt, of the FDA's Division of Advisory Committee and Consultant Management, wrote. “We will not be able to accept any written submission at this time.”

McWilliams said in an e-mail response to Bhatt, “I think the American public would want to know why the FDA has refused to consider important safety information that Bayer did not consent to be released to the public or the FDA until after the submission deadline.''

“Why not look at the documents and make your own independent objective evaluation?'' McWilliams said.

Bhatt didn't return a call after regular business hours yesterday seeking comment on that e-mail.

10,000 Lawsuits

Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. The first trials are scheduled for next month in federal court in Illinois and state court in Philadelphia.

Bayer's contraceptives generated $1.58 billion (1.17 billion euros) in sales last year, making them the company's biggest-selling drugs after Betaseron, a multiple sclerosis medication. The contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety. Bayer's Yasmin was the No. 4 oral contraceptive in the U.S. this year as of September, with 4.6 percent of the market, according to data from IMS Health.

In October, the FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer's Yasmin line of birth-control pills, according to the FDA report. The agency set the Dec. 8 hearing to discuss the findings.

Health Risks

The lawsuits claim Bayer didn't sufficiently warn patients of the health risks of the Yasmin family of birth-control pills. They also claim Bayer's Berlex Laboratories Inc., acquired in the 2006 purchase of Schering AG, marketed the drug for unapproved uses.

This marketing campaign, according to the documents unsealed yesterday, included paying $450,000 to Los Angeles gynecologist Judith Reichman to sponsor a tour for a book she was writing on women's health issues, among other items, Kessler said.

Kessler said the Bayer unit withheld information about Yasmin's risks of clots before the drug was approved by the FDA in 2001.

Internal Study

Bayer didn't report to the FDA details on the risks of clots from an internal study and two cases of clots in patients on the pill prior to the drug's approval by the agency, Kessler said.

“Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin's NDA could be made,” he said, referring to the company's new drug application.

“These facts would impact the agency's risk-benefit equation about the drug and whether it could be approved,” Kessler said.

The FDA told Bayer in June 2003 that it was “very concerned” about the number of adverse events, particularly deaths, reported in Yasmin users, Kessler said, citing an agency letter to the company. This included six deaths in the U.S., five of which were first reported to the FDA after April 2, 2003, the agency said.

“Because of these recent reports, we believe that a change in Yasmin labeling and possibly additional actions are now warranted,” the FDA wrote to Bayer, according to the Kessler report.

‘White Paper'

Bayer responded that its data didn't show a higher risk for Yasmin. Internally, the company decided to produce a “White Paper,” to the FDA, which would be “a scientific write-up that lays out the issues,” according to a Bayer document quoted by Kessler.

The white paper would compare Yasmin to other oral contraceptives, or OCs, covering multiple adverse events including venous thromboembolism (VTE) and pulmonary embolism (PT).

In an early draft of that report, Bayer employees wrote, according to Kessler, “Compared to the three other OCs, Yasmin has a several fold increase in the reporting rates for DVT, PE, ATE and confirmed VTEs.”

In this draft, the employees added: “When considering only serious AEs (adverse events), the reporting rate for Yasmin was 10 fold higher than with the other products.” The total rate of confirmed VTEs per year was three or four times higher than the other three oral contraceptives reviewed, according to the data in the draft, Kessler said. The raw numbers were 6.9 per year for Yasmin and 1.5 for two of the other pills, according to the draft.

‘Spontaneous Reporting'

In a later draft, the Bayer employees said that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin and other OC users.”

Such data wasn't the “preferred approach to assess the safety of a single product,” the researchers wrote. They said data from a direct comparison, such as two then-ongoing studies “should provide more insight.”

“The spontaneous reporting do NOT signal a difference in VTE rates for Yasmin,” another Berlex employee wrote to company colleagues in commenting on the draft, Kessler said. “Those comments were not accompanied by any additional data,” Kessler said.

Media Attention

Kessler agreed that spontaneous reporting of incidents has limitations, because of the voluntary nature of the reports, effects of media attention, different times of introduction for drugs, among other factors. The information still should have been included, he said.

“Even with its limitations, analysis of spontaneous reporting data is an important, recognized and vitally used tool by the FDA and the pharmaceutical industry for detecting safety signals” Kessler said in his report.

“Bayer's spontaneous reporting analysis demonstrated a safety signal about Yasmin and VTE risk,” he said. “Bayer had a duty to present a full and balanced view of all the data and analysis concerning Yasmin to the FDA and health-care professionals and failed to do so.”

Women suing Bayer over its line of birth-control pills contend the company and its units went to unusual lengths to market the medication for unapproved uses, according to court papers.

Marketing Drugs

Bayer's Berlex unit came up with a plan to hire Judith Reichman, a Los Angeles-based gynecologist who writes a blog about women's health issues, “to engage in off-label promotion” of the Yasmin line of contraceptives, John Abramson, a Harvard medical school professor, concluded in his report.

Abramson was hired by plaintiffs' lawyers to review materials Bayer turned over about the marketing of the drugs. His report was also unsealed yesterday by a federal judge in Illinois who is overseeing a consolidation of Yaz cases.

Berlex officials said in an e-mail they'd agreed to pay Reichman $450,000 in return for her willingness to “mention off-label benefits of our products,” Abramson noted. The doctor was planning an upcoming book on women's health issues.

The company also planned to purchase 10,000 copies of the book, which contained “off-label claims” about the Yasmin line of contraceptives, the doctor noted. The purchase was part of a “strategy to have the book appear on the New York Times bestseller list,” Abramson added.

In her 2005 book, “Slow Your Clock Down,” Reichman wrote that Yasmin may help women with PMS-related symptoms such as “fluid accumulation and bloat,” or with depression.


The FDA approved Yasmin only as a contraceptive. The regulator hasn't cleared it as a treatment for any form of PMS or other ailments, according to the agency's website. Reichman was unavailable to comment about her work with Bayer because her husband died, her assistant, Deborah Cannon, said in an e-mail.

Berlex officials understood the value of such publicity, Abramson noted. For example, Talarico, a then-spokeswoman for Berlex, flagged a copy of a 2006 story about Yaz in Allure magazine that touted the benefits of Yaz for treating PMS.

Richard Salem, Berlex's vice president for communications, congratulated Talarico for getting the article placed in the magazine.

“The value of these placements is astronomical,” Salem said in an e-mail, according to court filings.

Commercial Success

Internal e-mails also show officials of Bayer and its Berlex unit engaged in an extensive public relations campaign to market Yaz that was “designed to circumvent FDA restrictions on marketing” because they saw the limits “as a threat to the commercial success of Yaz,” Abramson said in his report.

The Kessler and Abramson reports were sent to the FDA by McWilliams, a lawyer with Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor PA in Pensacola, Florida.

“Although these reports were prepared for litigation, they contain relevant information obtained from Bayer that has not been previously provided to the FDA that will assist the committee and the FDA in its own evaluation of the benefits and risks of drospirenone-containing oral contraceptives,” McWilliams wrote to the agency.

The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, U.S. District Court, Southern District of Illinois (East St. Louis).

New FDA News on Yaz Warnings

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FDA favours more birth control pill info on labels.  New warnings on Yaz Birth Control labels

U.S. health regulators are leaning toward adding new information about the risk of blood clots to the labels of widely prescribed birth control pills such as Yaz, in light of growing evidence that the newer contraceptive drugs may be riskier than older drugs.

In documents released Tuesday, the U.S. Food and Drug Administration said there is conflicting evidence about the risk, but that the information should appear in labeling used by doctors and patients. Sorting out the blood clot risk of birth control drugs is especially difficult because all hormone-based contraceptives increase the risk of clotting, researchers say.Sorting out the blood clot risk of birth control drugs is especially difficult because all hormone-based contraceptives increase the risk of clotting, researchers say. iStock

"We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility," state the briefing documents from FDA scientists.

On Thursday, the FDA will ask a panel of outside experts to weigh in on the issue and to consider whether some women should not take the drugs. The agency is not required to follow the panel's advice, though it often does.

Yaz and several other pills contain a manmade hormone called drospirenone which was heavily marketed as carrying fewer side-effects than earlier drugs.

But over the last two years several large, independent studies have suggested the rate of blood clots with drospirenone-containing drugs is slightly higher than with other hormone-based contraceptives. The most recent analysis by FDA estimates that 10 in 10,000 women on the newer drugs will experience a blood clot per year, compared with 6 in 10,000 women on older contraceptives.

Studies conducted by German drugmaker Bayer, which markets Yaz and related pill Yasmin, found no increased risk of blood clots.

Sorting out the blood clot risk of birth control drugs is especially difficult because all hormone-based contraceptives increase the risk of clotting. Further complicating the issue is that clots can be caused by lifestyle factors such as smoking, obesity and family history.

FDA scientists say none of the existing studies provide a definitive answer and that new studies are needed.

"The entire body of studies provides conflicting evidence that cannot be easily reconciled by any single difference among studies," states the agency's review.
Marketing birth control drugs

Looking across the half-dozen studies available, FDA scientists say the risk of blood clots appears most likely in the first 3 to 6 months taking a drug, and increases among older women.

Most birth control drugs use a combination of two female hormones, estrogen and progestin, to stop ovulation and thicken cervical mucus, which helps block sperm. For decades many women have reported bloating and mood swings as side-effects.

Introduced in 2001, Yasmin was the first birth control pill to use a new form of progestin called drospirenone, which appeared to have fewer side-effects. The reformulated version of the drug, Yaz, was approved in 2006 with new claims on the label that it decreased acne and a severe type of mood disorder.

With the slogan, "beyond birth control," Bayer's advertisements pitched Yaz to women in their 20's as an alternative to older generations of contraceptives. One advertisements featured young women singing the Twisted Sister anthem, We're Not Gonna Take It, while popping balloons labeled "moodiness," "bloating" and "acne."

Within two years, Yaz had grown into the best-selling birth control pill in the U.S. with peak sales of $781 million US in 2009, according to data from IMS Health. But sales plummeted more than 50 per cent the following year after the company was forced to run corrective TV and magazine advertisements.

The FDA said the company's commercials suggested Yaz could treat premenstrual syndrome. In fact, the drug has only been shown to decrease incidence of a much more serious mood disorder called premenstrual dysphoric disorder. Additionally, the FDA said Bayer's commercials used distracting music and visuals to downplay the drug's list of side-effects.

In the first half of this year, Yaz ranked fourth among contraceptive pills sold in the U.S., behind Warner Chilcott's Loestren, Johnson & Johnson's Ortho Tri-Cyclen and a generic version of Yaz marketed by Teva Pharmaceuticals, according to IMS Health.

Newer drugs like Yaz are no more effective than older pills, generally allowing one unplanned pregnancy per year for every 100 women.

Earlier this week, Health Canada said birth control pills such as Yasmin and Yaz, which contain drospirenone, may be associated with up to three times the risk of blood clots compared with other oral contraceptives

Lawyers for Zocor

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New FDA Warnings for Zocor ,Kidney Failure,Muscle Injury Lawyers, Zocor class Action Lawyers

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Type 2 Diabetics, Actos and Bladder Cancer

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  Type II  Diabetics are showing side effects from actos. There have been significant reports showing the relationship between actos and bladder cancer. It is alleged that the manufacturer should have been aware and warned Type 2 Diabetics about actos side effects.
      ACTOS is a prescription drug used with diet and exercise to improve blood sugar (glucose) control in adults with type ii diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis. It is impossible for a patient to assess the safety of a drug before taking it.. Helpless and vulnerable patients rely on others such as drug manufacturers,physicians and pharmacists to help make the right decision regarding the medications they take. While many drugs do what they are intended to do and help relieve symptoms improve quality of life, some drugs are defective and dangerous. Patients trust the physicians and when a "good" drug turns bad they do not know where to turn. Some groups have a higher risk for developing type 2 diabetes than others. Type 2 diabetes is more common in the aged population.Caregivers must step up to assist their older patients who are affected by actos Being the primary caregiver for a person who has diabetes can take an emotional toll. A diabetes caregiver may be the one taking ownership of his or her loved one's diabetes if the person with diabetes doesn't or can't. There may be feelings of guilt,that is why they must step up on behalf of their patients and loved ones to protect them. Actos has been shown to have serious side effects including heart problems and bladder cancer. EHealthMe conducted a study on August 17, 2011 regarding the side effects of taking Actos and the bladder cancer risk. According to the report, 22,512 reported side effects when taking Actos and 0.22% have bladder cancer. The largest concentration (approx. 43%) were using Actos between 2-5 years before having Bladder Cancer with the next largest concentration (approx. 29%) used Actos between 1-6 months. Older populations and many minority groups  are effected by these new findings.

TYpe II Diabetes Information

          Type 2 diabetes, also known as adult-onset or noninsulin-dependent diabetes, is a chronic condition that affects the way your body metabolizes sugar (glucose), your body's main source of fuel.Insulin is a hormone that regulates the movement of sugar into your cells.With type 2 diabetes, your body either resists the positive effects of insulin or doesn't produce enough insulin to maintain a normal glucose level. Untreated, type 2 diabetes can be life-threatening. Complications of Diabetes Diabetes can lead to high blood sugar levels, a condition called hyperglycemia. Over a long period of time, hyperglycemia damages the retina of the eye, the kidneys, the nerves, and the blood vessels.Damage to the retina from diabetes (diabetic retinopathy) is a leading cause of blindness.Damage to the kidneys from diabetes (diabetic nephropathy) is a leading cause of kidney failure. Damage to the retina from diabetes (diabetic retinopathy) is a leading cause of blindness.Damage to the nerves from diabetes (diabetic neuropathy) is a leading cause of foot wounds and ulcers, which frequently lead to foot and leg amputations.Damage to the nerves in the autonomic nervous system can lead to paralysis of the stomach (gastroparesis), chronic diarrhea, and an inability to control heart rate and blood pressure during postural changes
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           Damage to the nerves in the autonomic nervous system can lead to paralysis of the stomach (gastroparesis), chronic diarrhea, and an inability to control heart rate and blood pressure during postural changes.Diabetes accelerates atherosclerosis, (the formation of fatty plaques inside the arteries), which can lead to blockages or a clot (thrombus). Such changes can then lead to heart attack, stroke, and decreased circulation in the arms and legs. Damage to the nerves from diabetes (diabetic neuropathy) is a leading cause of foot wounds and ulcers, which frequently lead to foot and leg amputations(peripheral vascular disease).Damage to the nerves from diabetes (diabetic neuropathy) is a leading cause of foot wounds and ulcers, which frequently lead to foot and leg amputations.Damage to the nerves in the autonomic nervous system can lead to paralysis of the stomach (gastroparesis), chronic diarrhea, and an inability to control heart rate and blood pressure during postural changes. Diabetes accelerates atherosclerosis, (the formation of fatty plaques inside the arteries), which can lead to blockages or a clot (thrombus). Such changes can then lead to heart attack, stroke, and decreased circulation in the arms and legs (peripheral vascular disease).As of June 10, 2011 doctors in France and Germany have been instructed not to proscribe the drug Actos to their  Type II Diabetic patients and the drug Actos has actually been removed from pharmacy shelves. The reason for these actions is because recent studies have shown that an patients who use the drug Actos to treat their Type II Diabetes by using Actos are more likely to contract bladder cancer.
               What makes this fact more difficult to accept is that it appears that the incidence of Bladder Cancer in Type II Diabetics using the drug Actos, was known to the drug manufacturer Takeda, Inc. in the clinical trials However, even though, Takeda, Inc. apparently knew that the drug Actos would cause bladder cancer, it still marketed and sold 2.3 million prescriptions for the drug Actos in the United States in one year alone. 2010. The active ingredient in Actos, Pioglitazone, is also used in ActoPlus met, ActoPlus met XR and Duetac to treat Type 2 Diabetes.
              On June 15, 2011, the FDA issued an urgent health warning to users and prescribers of the drug Actos acknowledging the recent statistical data that shows up to a 40% increase in risk for bladder cancer in users of Actos. The studies further show that the risk of bladder cancer increases with higher dosages and longer courses of treatment with Actos.In one study involving more than 193,000 patients with diabetes, patients taking Actos were on the drug for an average of two years, the FDA said. "Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40 percent increase in risk [for bladder cancer]," the agency said. A French study examined cancer rates in some 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics who were not receiving the drug. The study found about a 22 percent higher risk of bladder cancer in those taking Actos compared with diabetics taking other drugs. The bladder cancer risk was highest in those receiving a cumulative Actos dosage of 28,000 mg or more during the study period.Patients taking the diabetes drug Actos for more than a year may have an increased risk of bladder cancer, according to an FDA interim review of an ongoing epidemiological study.After the health warning was issued the FDA will now require that these recent findings and risks be included in warnings attached to the drug packaging and future marketing materials. The FDA is also going to continue monitor the data being released by various.  So  far, Actos remains available to consumers in the United States despite these risks

Class Action Lawyer Network  Actos team is ready to help you. If you or a loved one has been injured by actos call now and speak to our medical MSW. As a caregiver for someone who may be a victim of Actos you should call us immediately and get the facts.

Actos Avandia linked to Diabetic Macular Edema

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Actos Side Effects Could Include Eye Disease
September 21, 2011, 10:30:00AM. By Heidi Turner 

    San Diego, CA: A new study suggests Actos side effects could include an increased risk of eye disease. This is in addition to a reported link between Actos and bladder cancer, and a possible link between Actos and heart failure.

    Actos Side Effects Could Include Eye DiseaseThe study was presented in June at the American Diabetes Association's annual meeting. According to Bloomberg (06/24/11), the study found that patients who took Actos had three to six times the increased risk of developing diabetic macular edema, a condition that can result in blindness. Patients with diabetic macular edema experience swelling and thickening in the retina, which ultimately damages the retina and can lead to vision loss.

    Researchers recommended that patients with a risk of diabetic macular edema should avoid Actos and Avandia (a drug in the same class as Actos).

    This is not the first time Actos has been linked to diabetic macular edema. In 2003, results of a retrospective study found that use of drugs in the glitazone class (which includes Actos and Avandia) could result in an increased risk of diabetic macular edema. The study was presented at the annual meeting of the American Academy of Ophthalmology and reported by Medscape (11/19/03). According to the article, patients included in the study had clinically significant macular edema in at least one eye and also had lower extremity edema.

    Researchers found that once glitazone use was stopped, lower extremity edema reversed and patients lost weight. Furthermore, patients experienced a reduction of diabetic macular edema within one to two years of discontinuing medication.

    In 2008, a case study published in Vascular Health and Risk Management shared the story of a 30-year-old woman who developed severe diabetic macular edema after using pioglitazone (the generic name for Actos). The patient had proliferative diabetic retinopathy prior to beginning pioglitazone therapy, but did not have diabetic macular edema. Researchers noted that within two weeks of beginning pioglitazone therapy, the patient developed severe diabetic macular edema in both eyes, as well as experiencing weight gain.

    Within two weeks of stopping pioglitazone use, the patient's vision had improved, but she still had severe diabetic macular edema. The edema was finally resolved with the application of half a usual dose of a diuretic.

    At the time, researchers recommended that physicians treating patients who complain about decreased vision after starting pioglitazone therapy should consult an ophthalmologist.

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