Posts Tagged ‘fda label change for birth control pills’

Yaz Birth Control Pills pay-off, Yaz Lawyers Ready to file

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

Good News  Ladies Perhaps we will see the same with the vaginal mesh lawsuits or even more.

Bayer Said to Pay $110 Million in Yaz Birth-Control Cases

  • Vaginal mesh helpline keeps women informed on all dangerous drugs and medical devices harming women. The $220,000 settlement per case gives hope to our callers suffering from the vaginal mesh. Just like the vaginal mesh women who took  Yaz birth control pills or Yasmin  never imagined that the side effects could harm them as much as they did. But countless women were affected. They suffered many serious injuries that often changed their lives permanently:
  •     Blood clots (deep vein thrombosis or DVT)
  •     Pulmonary embolism
  •     Gallbladder disease
  •     Pancreatitis
  •     Heart attacks
  •     Strokes (both ischemic and hemorrhagic strokes)

Again we say women who have been injured by Yaz must demand justice. If you have had one of the listed complications you must contact our helpline and speak to a Yaz attorney immediately. You still may have a chance. Some states are out of time. Do not wait. If you have been injured by one of the many drugs or medical devices harming women like yaz, Vaginal mesh, Mirena IUD cantact our helpline today.

By Jef Feeley and Margaret Cronin Fisk – Apr 13, 2012 5:48 PM ET

Bayer, Germany’s largest drugmaker, will pay at least $110 million to settle about 500 lawsuits over claims that its Yasmin line of birth-control pills caused blood clots, in the first resolution of cases over the product, people familiar with the agreements said.
Officials of Bayer, based in Leverkusen, Germany, agreed to pay an average of about $220,000 a case to resolve the claims that its Yasmin and Yaz contraceptives caused sometimes fatal clots that can lead to heart attacks and strokes, two people familiar with the settlement said. The people sought anonymity because the accords haven’t been made public.
Bayer fell 2.5 percent in German trading today, and its American depositary receipts dropped 3.8 percent. The settlements came after a federal judge in Illinois postponed a Jan. 9 trial of a suit accusing Bayer and some of its units of misleading women about the health risks of its birth-control pills so a mediator could try to negotiate a settlement.
The case was the first set for trial of more than 11,000 lawsuits over injuries allegedly caused by the drugs.
“Sounds to me like mediation is paying off,” Carl Tobias who teaches product-liability law at the University of Richmond, said in a phone interview. “As a German company, Bayer probably would like to avoid the risks and costs of litigation in U.S. courts. Mediation tends to be a less- expensive way to deal with these kinds of cases.”

Stronger Warnings

The settlements come as the U.S. FDA April 10 ordered Bayer and other contraceptive makers to strengthen the blood-clot warnings on their products.
Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.
Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them the drugmaker’s biggest-selling drugs after Betarson a multiple sclerosis medication. The Yasmin drugs have been the focus of regulators who question their safety.
“Bayer HealthCare confirms that some cases pending in the current YAZ/Yasmin litigation in the U.S. are being settled,” RY a U.S. spokeswoman for the drugmaker, said in an e-mailed statement. She declined to comment on the number of cases settled or the amount of the accords.
Bayer’s American depository receipts, each worth one ordinary share, fell $2.60, or 3.8 percent, to $65.83 in over- the counter trading today. Shares in Germany dropped 1.28 euros, or 2.5 percent, to 50.56 euros.

Prior Settlements

Bayer officials said in a Feb. 28 U.S. Securities and Exchange Commission filing that the drugmaker has settled 70 cases over the Yasmin line of contraceptives.
Those settlements included “terms and conditions which Bayer views to be reasonable,” officials said in the filing. “Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis.”
The company is expecting additional suits, officials said in the SEC filing Last year, the U.S. FDAwarned 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 more than 835,000 women who took pills containing Drospirenone including Bayer’s Yasmin line of birth-control pills, according to the FDA report.
Bayer’s Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.

Wave of Litigation

Since 2009, the German drugmaker has faced a wave of lawsuits in courts across the U.S. alleging the birth-control pills caused sometimes fatal blood clots. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008.
Lawyers for former Yaz users contend in court filings that Bayer officials sought to market the contraceptive fgor unapproved uses and misled women about the drug’s health risks
The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in St Louis for pretrial proceedings.

Scheduled Trials

Herndon scheduled a series of trials for early this year so juries could begin weighing claims that Bayer and its units marketed Yaz and other contraceptives as safer than rivals’ products while knowing they posed a higher clot risk.
At Bayer’s suggestion, Herndon called in Stephen Saltzburg, a George Washington University law professor, to serve as a mediator. Saltzburg’s job was to explore the possibility of “settlements in this litigation,” Herndon said in a December 2011 order. The judge put the trial schedule on hold while Saltzburg met with lawyers for the drugmakers and former Yaz users.
Among the lawyers settling Yaz cases as a result of Saltzburg’s efforts are Mark Robinson Chris Seeger and Michael Berg the people familiar with the accords said.
Those three lawyers are serving on the so-called plaintiffs steering committee in the cases before Herndon, according to court filings That group helps decide how the consolidated cases should progress through the litigation process.
Burg, a Denver-based plaintiffs’ lawyer who handles product-liability cases, also is listed in court filings as co- lead plaintiffs’ counsel in the Yaz cases. He declined to comment on the settlements in a interview today.
Seeger, based in New York, and Robinson, a Los Angeles- based attorney, didn’t immediately return calls seeking comment on the settlement.
The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).
Call the Yaz Women's helpline today

 

Blood Clots,Birth Control Pills Containing Drospirenone, Lawyers Accepting Cases

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

The Vaginal Mesh Helpline is keeping women updated on all drugs and medical devices effecting women.Womens health lawyers division is watching all implants, drugs and medical devices that harm women. FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.We are posting this announcement to keep women informed of the risks. If you are effected by this warning andhave had these complications please contsac our helpline to be connected to a lawyer. We are horrified at the number of drugs and medical devices that are harming women. Vaginal Mesh, Mirena IUD, Yaz, Yasmine and others are harming women nationwide. We must seek justice.

On April 10, 2012, the U.S. Food and Drug Administration (FDA) announced a label change for drospirenone-containing birth control pills, such as Yaz and Yasmin, to include the increased risk for developing dangerous blood clots.

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11:  Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.

Safety Announcement

[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin.  Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.  See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots.  For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.

The revised drug labels (Beyaz, Safyral, Yasmin ,Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.

Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; for women who use birth control pills; for pregnant women; and for women in the postpartum period.  For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.

Figure 1: Likelihood of Developing a Blood Clot

Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; who use birth control pills; and for women in the postpartum period
COC = combination oral contraceptives or birth control pills

These studies were discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.

Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011.  The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins.  Previously published studies had reported conflicting findings.  The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives.  The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

Today's communication is in keeping with FDA's commitment to inform the public about the Agency's ongoing safety review of drugs.  FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.

Table 1. Approved Oral Contraceptives Containing Drospirenone

  • Beyaz
  • Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
  • Drospirenone and ethinyl estradiol
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Drospirenone and ethinyl estradiol
  • Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Gianvi
  • Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Loryna
  • Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Ocella
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Safyral
  • Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
  • Syeda
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Yasmin
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg
  • Yaz
  • Drospirenone 3 mg and ethinyl estradiol 0.02 mg
  • Zarah
  • Drospirenone 3 mg and ethinyl estradiol 0.03 mg

    Updated External Questions and Answers – Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots

    4-10-2012

    Beyaz Label

    4-10-2012

    Safyral Label

    Yasmin Label

    4-10-2012

    Yaz Label

    FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone

    9-26-2011

    FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone

    10-27-2011

    FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

    5-31-2011

    FDA Briefing Information for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 1.86MB) (PDF – 5.2MB)

    FDA Drug Safety Podcast for Healthcare Professionals: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

Vaginal Mesh Helpline Announces new helpline for women harmed by these birth contol pills.