Buy this domain.

Yaz Documents Indicate Bayer May Have Pushed Off-Label Use | cialis online

Yaz Documents Indicate Bayer May Have Pushed Off-Label Use

AddThis Social Bookmark Button

Yaz documents indicate that Bayer might have pushed the Yasmin family of birth control pills for off-label uses. In doing so, drug giant Bayer AG, likely misled women about the drugs’ side effects and health risks.

Company files show that Bayer’s Berlex Laboratories Inc. unit officials touted Yaz to treat all types of premenstrual syndrome; however, the oral contraceptive was only approved in the U.S. for the treatment of PDD—premenstrual dysphoric disorder—a more serious condition than PMS, that causes anxiety, tension, and persistent anger, to name a few.

Sales staff for Berlex, which was acquired in Bayer’s 2006 purchase of Schering AG, discussed a 2006 email from Matt Sample, a Berlex sales consultant, who discussed a Woman’s Day magazine article about Yaz. “This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific” class of women diagnosed with PDD, said Businessweek, citing the email that is now part of evidence in the case. Sample encouraged sales reps to use the article to ask doctors “what percentage of your patient population suffers from” symptoms seen in PMS versus PDD and “what they think the impact of Yaz will be,” reported Businessweek, citing Bayer emails.

The email and other internal files were released during discovery—the pre-trial evidence exchange—and state that Yaz caused blood clots, heart attacks, and strokes. Businessweek noted that Bayer now faces over 10,000 lawsuits over injuries allegedly linked to Yaz and Yasmin; plaintiff attorneys cite U.S. Food and Drug Administration (FDA) reports of no less than 50 deaths from 2004 to 2008 linked to the drugs.

Bayer is accused of off-label marketing; withholding critical information from patients, doctors, and regulators about increased blood clot risks; and of wrongfully touting Yasmin and Yaz as being as safe as its competitors’ birth-control pills, said Businessweek. Trials are scheduled to begin in January in Illinois and Pennsylvania.

A 2002 email from former Berlex executive, Kimberly Schillace and a contract with gynecologist, Dr. Judith Reichman, a blogger, and women’s health issue expert, and a regular contributor the NBC’s “Today” show are also involved. According to the documents, Schillace wrote that she spoke with Dr. Reichman: “She definitely will mention the off-label benefits of our products…. Attached please find the contract,” the email states; agreement details were not included in the message, said Businessweek. In a 2003 article, Reichman wrote that some studies state that Yasmin “may be helpful in diminishing PMS-like symptoms”; in her 2005 book, “Slow Your Clock Down,” Reichman said Yasmin may help minimize PMS-related symptoms including “fluid accumulation and bloat” and depression, Businessweek reported.

Bayer promoted Yasmin for uses that did not receive regulatory approval, said NewsInferno, noting that Yasmin and Yaz, are low-estrogen pills made with a type of progestin called drospirenone, known to carry serious health risks. The FDA issued a warning letter to Bayer citing two Yaz commercials that made deceptive claims, and faulting Bayer for overstating the benefits of Yaz and minimizing the drug’s risk of dangerous side effects. Bayer agreed to stop running the offending Yaz ads and began running a “corrective advertising campaign” as a part of an agreement with the FDA and attorneys general in 27 states. The FDA letter said no evidence proves that Yaz can eliminate the PMS symptoms it touts it can treat in its advertisements.

In 2009, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency cited Bayer for a claim that drospirenone “has a positive effect … on fluid retention,” which the agency said was not supported by adequate evidence.

« »

Leave a Reply

You must be logged in to post a comment.




Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!

Whistle Blower

Stand up and say what you think is right. See something, say something.