San Diego CA (PRWEB) February 08, 2013
Consumer advocates at Resource4thePeople, acting upon recent Food and Drug Administration warnings about possible blood-clotting dangers associated with contraceptives Yaz and Yasmin, are announcing they are offering assistance to help victims obtain legal aid.
“We are concerned that there may be many women who are unaware that they have legal options stemming from warnings in the recent FDA Drug Safety Communication* that provided updated information about the risk of blood clots in women taking birth control pills such as Yaz and Yasmin that contain drospirenone,” said Resource4thePeople.
Resource4thePeople said that it has still not been determined how many of the millions of American women who chose Yaz or Yasmin as their method of birth control may be affected by the FDA’s Safety Communication.
“Unfortunately, there are many women who either do not have access to such information about the safety of these birth control pills or are unaware of the warnings about possible risks of blood clots that have been issued by our government,” said Resource4thePeople
Women who have filed Yaz and Yasmin blood-clotting lawsuits have claimed that they suffered blood clots, deep vein thrombosis, strokes and pulmonary embolisms as a result of their use of the contraceptives according to allegations contained in their lawsuits.
There have been so many of these Yaz and Yasmin blood-clotting lawsuits filed over claims of severe health problems that the federal court system has coordinated many of them in what is called a multi-district litigation.
Court records show that this special litigation is now in pre-trial evidence gathering and settlement talks before a federal judge who is overseeing thousands of such lawsuits in Illinois.**
Resource4thePeople said that as more Yaz and Yasmin blood-clotting victims come forward it will continue to provide referrals to lawyers offering free consultations.
These consultations can provide legal options to victims who may have suffered health problems as outlined in the April 10, 2012 FDA warning which said:
“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.”
In its announcement the FDA said that “The revised drug labels (Beyaz, Safyral, Yasmin and 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.”
Resource4thePeople also is announcing that it is making available blogs, reports, FDA announcements and other information about links between Yaz and Yasmin and blood-clotting dangers available to women on the organization’s web site.
“We believe that women should be fully informed about the risks that they may be putting their bodies and their health at through the use of birth control devices and other medications,” said Resource4thePeople.
Meanwhile, Resource4thePeople is recommending that women who are either using Yaz, Yasmin and other drospirenone contraceptives or considering doing so to completely review the FDA’s findings. Among them are these FDA recommendations:
- Women should talk to their health care professional about their risk for blood clots before deciding which birth control method to use.
- Health care 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 FDA in its 2012 announcement noted that it has issued previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone on May 31, 2011, September 26, 2011, and October 27, 2011.
The May 2011 communication 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.
The FDA said 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 FDA said.
“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.”
** In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation MDL No. 2100, U.S. District Court, Southern District of Illinois