Pharmaceutical Drug Litigation Updates

EU agency to review safety of newer contraceptive pills | Reuters

Quoted from http://www.reuters.com/article/2013/01/28/us-contraceptives-europe-idUSBRE90R0QM20130128

EU agency to review safety of newer contraceptive pills

LONDON | Mon Jan 28, 2013 12:11pm EST

LONDON (Reuters) - The European Medicines Agency is to review the safety of third and fourth-generation combined oral contraceptives to decide if there is a need to restrict their use.

Monday's move followed a request by France, where authorities have already taken steps to reduce use of the drugs in favor of second-generation birth control pills.

The newer pills, which include Bayer's Meliane or Yasmin, have proved popular because they reduce side effects seen with earlier versions, such as weight gain and acne.

But France wants the European Union regulator to restrict their use because of concerns they carry a higher risk of dangerous blood clots.

While all oral contraceptives are associated with some danger of blood clots, a number of studies suggest the most recent third- and fourth-generation pills carry a higher risk than their predecessors.

[Article continues at original source]

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EU agency sees no new risks with combined contraceptives

Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe

France will ask EU to curb use of newer birth control pills

France will ask EU to curb use of newer birth control pills

Quoted from http://www.reuters.com/article/2013/01/11/france-contraception-eu-idUSL5E9CB6UE20130111

France will ask EU to curb use of newer birth control pills

By Elena Berton

PARIS | Fri Jan 11, 2013 10:09am EST

PARIS Jan 11 (Reuters) - French health authorities will ask the European Union to restrict the use of newer types of contraceptive pills over concerns they might carry health risks.

France's health minister Marisol Touraine said on Friday the newer pills, which have caught on because they reduce side effects from earlier versions such as weight gain and acne, should only be prescribed by specialist doctors to women who cannot use other types of contraception.

Dominique Maraninchi, head of France's health regulator, said at the same news conference: "We will ask Europe not to suspend the pills but to modify prescription guidelines."

While all oral contraceptives are associated with a risk of blood clots, a number of studies suggest the most recent third and fourth-generation pills carry a higher risk than their predecessors.

[Article continues at original source]

Related articles

Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe

Swiss health insurer makes claim against Bayer over Yasmin pill

November 2012 Litigation And Settlement Update: YAZ, Yasmin, Ocella, And Gianvi Lawsuits

Swiss health insurer makes claim against Bayer over Yasmin pill

Quoted from http://www.reuters.com/article/2013/01/09/us-bayer-swiss-yasmin-idUSBRE9080LN20130109

Swiss health insurer makes claim against Bayer over Yasmin pill

ZURICH/FRANKFURT | Wed Jan 9, 2013 8:53am EST

ZURICH/FRANKFURT (Reuters) - Switzerland's biggest health insurer CSS is supporting a young woman in her claim against Bayer, as the fall-out from alleged side effects of the German drugmaker's contraceptive pill Yasmin widens.

Bayer is already under fire in other markets over new-generation contraceptives. France will stop reimbursing prescription costs of some types from March, after a woman sued Bayer over alleged side effects.

CSS said on Wednesday it supported its client in her claim against Bayer and is acting as a joint plaintiff. The health insurer is demanding payment from Bayer to cover medical costs.

Swiss media reported the young woman suffered from a pulmonary embolism that left her severely disabled a few weeks after being prescribed the pill. The cost of medical treatment has amounted to some 600,000 Swiss francs ($648,600), according to reports.

[Article continues at original source]

Related articles

Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe

November 2012 Litigation And Settlement Update: YAZ, Yasmin, Ocella, And Gianvi Lawsuits

Birth Control That Uses Combined Hormones Raises Heart Risk: Study

Quoted from http://health.msn.com/womens-health/birth-control-that-uses-combined-hormones-raises-heart-risk-study

Birth Control That Uses Combined Hormones Raises Heart Risk: Study

Overall odds of heart attack and stroke, however, are still low

By Maureen Salamon
HealthDay Reporter

WEDNESDAY, June 13 (HealthDay News) -- Sweeping new research comparing various forms of hormonal contraception -- including birth control pills, vaginal rings and skin patches -- suggests that the risk for heart attacks and strokes is twice as high among users of combined estrogen-progestin versions.

These include brands such as Yasmin and Yaz pills, the NuvaRing vaginal ring and Ortho Evra patches. The overall odds of suffering such debilitating effects, however, are still quite low.

Analyzing 15 years of observational data from more than 1.6 million women aged 15 to 49, Danish scientists found that those taking low-dose estrogen birth control pills combined with various progestins suffered heart attacks and strokes between 1.5 and 2 times more often than women not using hormonal contraception. The risks were between 2.5 and 3 times higher among users of vaginal rings and transdermal patches compared to non-users.

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Bayer Birth-Control Pill May Boost Risks for Blood Clots

Quoted from http://www.bloomberg.com/news/2012-04-10/bayer-s-birth-control-pills-may-boost-blood-clot-risk-fda-says.html

Bayer Birth-Control Pill May Boost Risks for Blood Clots

By Anna Edney - Apr 10, 2012 4:12 PM ET

Bayer AG (BAYN)’s Yasmin and 10 other birth-control pills may pose a greater risk for blood clots in women using the drugs, and language on the labels must be strengthened to clarify those dangers, U.S. regulators said.

Pills containing drospirenone, a synthetic version of the hormone progesterone, will carry new labels about a review that showed as much as triple the risk for blood clots, the Food and Drug Administration said today in a statement. The research compared the drugs with low-dose estrogen pills. Some studies found no increased risk.

Bayer has faced a wave of lawsuits in the U.S. since 2009 alleging the Leverkusen, Germany-based drugmaker’s birth-control pills, which also include Beyaz and Yaz, 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.

“Bayer has consistently updated the FDA and other regulatory authorities around the world as new data have become available” about drospirenone-containing oral contraceptives, the company said today in a statement. Bayer “has worked with the agencies to make label updates, as appropriate.”

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Group seeks re-vote on birth control clot risk

Quoted from http://www.reuters.com/article/2012/01/13/us-fda-bayer-idUSTRE80C03320120113

By Anna Yukhananov

WASHINGTON | Thu Jan 12, 2012 7:51pm EST

WASHINGTON (Reuters) - A watchdog group on Thursday urged the Food and Drug Administration to hold a new vote about blood clot risks from popular birth control pills, after advisers to the agency were shown to have ties to the pillmakers.

The FDA asked outside experts in December to discuss the safety of birth control that contains the compound drospirenone, including Bayer's Yaz and Yasmin.

The panel decided by a four-vote margin that the benefit of pregnancy prevention from these pills outweighed their risk of dangerous blood clots.

But according to court and public documents, three of the FDA's 26 advisers had research or financial ties to Bayer. A fourth adviser had a connection to a manufacturer of generic copies of Yaz, Barr Laboratories, now part of Teva Pharmaceuticals.

All four of these advisers voted that the drugs' benefits outweighed risks, meaning the pills could stay on the market, according to the Project on Government Oversight (POGO).

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Watson plans to make generic version of Bayer's Yaz birth control pill

Quoted from http://www.nj.com/business/index.ssf/2011/11/watson_plans_to_make_generic_v.html

Watson plans to make generic version of Bayer's Yaz birth control pill

Published: Tuesday, November 29, 2011

By The Associated Press

Watson said has filed an application with federal regulators to make a generic version of Yaz, a birth control pill made by Bayer. Generic drugmaker Watson Pharmaceuticals said the Food and Drug Administration has approved its application to make a generic version of Bayer’s Yaz birth control pill called Vestura.

Watson currently is involved in patent litigation over the oral contraceptive with Bayer.

Yaz had U.S. sales of $173 million for the 12 months that ended Sept. 30, Watson said today.

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