Drug Safety Developments

Bayer Sued Over Alleged Hidden Risks of Mirena Contraceptive

Quoted from http://www.bloomberg.com/news/2013-01-28/bayer-sued-over-alleged-hidden-risks-of-mirena-contraceptive-1-.html

Bayer Sued Over Alleged Hidden Risks of Mirena Contraceptive

By Sophia Pearson - Jan 28, 2013 4:08 PM ET

Bayer AG (BAYN) was sued over claims the German drugmaker failed to provide disclosures and warnings regarding the health risks associated with its popular contraceptive Mirena.

The label for Mirena, an intrauterine device that prevents pregnancy for as long as five years, doesn’t warn that it can can become embedded in the body or cause an ectopic pregnancy, Pennsylvania resident Tricia Prendergast said in a complaint filed in federal court in Philadelphia. Prendergast required surgery to remove the device after complications, according to her complaint....

Mirena, approved by the Food and Drug Administration in December 2000, is made of flexible plastic designed for insertion in the uterus, where it releases a synthetic progestogen that inhibits pregnancy, according to the complaint. More than 15 million women worldwide use the product, including more than 2 million in the U.S., Prendergast said in the complaint.

[Article continues at original source]

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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GSK Playing Hardball With UK Families Over Avandia Litigation

Quoted from http://guardianlv.com/2013/01/gsk-playing-hardball-with-uk-families-over-avandia-litigation/

GSK Playing Hardball With UK Families Over Avandia Litigation

Added by GM on January 30, 2013.

 

Avandia Patients that have pending litigation in the United Kingdom may not be getting due compensation anytime soon, for those lawsuits against GlaxoSmithKline, (GSK) the manufacturer of the Avandia brand of Rosiglitazone, a diabetes drug discovered to increase risk factors for stroke and heart attacks in diabetics.

A study published in 2007 indicates that Rosiglitazone may increase fatalities from heart disease by as much as 43%.

Products containing Rosiglitazone, like Avandia, were pulled from the market in Europe in September 2010, but continue to be sold in the United States, under specific guidelines put forth by the U.S. FDA.

The European Medicines Agency (EMA) made recommendations in September 2010 that the drug be pulled from the European marketplace, and it is no longer sold there.

According to the FDA, Rosiglitazone may have been responsible for over 100,000 heart attacks in the U.S. alone, with no figure currently available for the U.K. or Europe.

GlaxoSmithKline, (GSK) has admitted to hiding evidence indicating the adverse side effects of Avandia, such as increased risk of heart disease, heart attack, stroke, bone fractures, macular edema, and hepatitis.

GlaxoSmithKline, (GSK) currently has settled over 3 billion dollars in lawsuits in the U.S., with estimates running as high as 6 billion dollars by the time all lawsuits are settled.

Product liability lawsuits in the U.K. are another matter all together.

[Article continues at original source]

Pfizer settles Alabama man's lawsuit against the company's smoking cessation drug Chantix

Quoted from http://blog.al.com/spotnews/2013/01/pfizer_settles_alabama_mans_la.html

Pfizer settles Alabama man's lawsuit against the company's smoking cessation drug Chantix

By Kent Faulk | [email protected] The Birmingham News
on January 15, 2013 at 10:12 AM, updated January 16, 2013 at 7:12 AM

BIRMINGHAM, Alabama - Pfizer Inc. has reached an undisclosed settlement in a lawsuit filed by a Demopolis man who claims the company's smoking cessation drug Chantix caused him to have suicidal thoughts and other psychological problems after he began taking it in 2007.

A trial over claims in the lawsuit was to begin Jan. 23 and was to have been the first test case to be tried among more than 2,600 lawsuits filed in federal court nationwide making claims about Chantix.

Ernest Cory, attorney for Billy G. Bedsole Jr., told U.S. District Judge Inge P. Johnson this morning that a settlement had been reached with Pfizer in the case during a hearing this morning. He told her that attorneys should have an order to her in the next 30 days for her to dismiss Bedsole's case.

[Article continues at original source]

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EU agency sees no new risks with combined contraceptives

Quoted from http://www.reuters.com/article/2013/01/11/us-contraceptives-europe-regulator-idUSBRE90A09N20130111

EU agency sees no new risks with combined contraceptive

LONDON | Fri Jan 11, 2013 3:59am EST

LONDON (Reuters) - European drug regulators said on Friday there was no reason for women to stop using combined contraceptives like Bayer's Meliane or Yasmin pills since there was no new evidence pointing to safety risks.

The move comes after French health regulators said last week they were considering limiting use of some birth control pills after a woman sued the German drugmaker over alleged side-effects.

In a statement responding to reports about the so-called "third-generation" contraceptive pills and blood clots known as venous thromboembolisms, the European Medicines Agency (EMA) said it was already well known that the pills "carry a very rare risk of blood clots".

It said that risk differs between types of combined contraceptives.

"These products are constantly and rigorously kept under close monitoring. There is currently no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today," the agency said. "There is no reason for any woman to stop using her contraception."

EMA says the risk of a blood clot is twice as high for women using third and fourth-generation pills than for those using earlier versions, although it remains low. The risk of a stroke is the same.

[Article continues at original source]

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

Swiss health insurer makes claim against Bayer over Yasmin pill

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]

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Swiss health insurer makes claim against Bayer over Yasmin pill

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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]

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

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