Drug Safety Developments

Newer Pill has low blood clot risk: ob-gyn group

Quoted from http://www.chicagotribune.com/health/sns-rt-us-newer-pillbre89n1h8-20121024,0,1693523.story

Newer Pill has low blood clot risk: ob-gyn group

Packages of Yasmin contraceptive pills lie on a table at a pharmacy (Andreas Rentz, Getty Images)

By Amy Norton Reuters

2:35 p.m. CDT, October 24, 2012

NEW YORK (Reuters Health) - A newer version of the Pill may carry a slightly higher blood clot risk than older formulations - but it's still a small risk, says the American College of Obstetricians and Gynecologists.

In new recommendations, the group says that women should be aware of the "possible minimally increased risk" of blood clots with birth control pills containing the hormone drospirenone.

Those include big-selling brands like Yaz, Yasmin, Beyaz and Safyral, along with their generic equivalents.

It has long been known that women on the Pill have a small, but higher-than-average risk of blood clots. And some recent studies have suggested that the risk is relatively higher with pills containing drospirenone.

But because of "study weaknesses," it's not certain whether that is the case, said Dr. Kavita Nanda, who helped draft the new ACOG recommendations.

And the absolute risk of blood clots with any birth control pill is small, ACOG says in a report in its journal Obstetrics & Gynecology.

For every 10,000 women using birth control pills over a year, there would be anywhere from three to nine cases of blood clots called venous thromboemboli. That compares with one to five cases for every 10,000 women who are not pregnant and not on the Pill.

With drospirenone-containing pills, some studies suggest there would be 10 cases per 10,000 women each year.

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Alabama man's Chantix lawsuit now set to be first test case

Quoted from http://blog.al.com/spotnews/2012/10/demopolis_mans_chantix_lawsuit.html

Alabama man's Chantix lawsuit now set to be first test case

Published: Thursday, October 18, 2012, 6:35 PM Updated: Friday, October 19, 2012, 6:47 AM

By Kent Faulk | [email protected] The Birmingham News

FLORENCE, Alabama - Billy G. Bedsole Jr. began taking the smoking cessation drug Chantix in August 2007 to try and break a 34-year habit.

The 53-year-old Demopolis man, however, claims in a lawsuit that the drug triggered "insomnia, severe anxiety, severe depression, erratic behavior, suicidal ideation, and hospitalization."

Bedsole's 2009 lawsuit is among 2,635 federal lawsuits filed nationwide against Pfizer Inc. claiming that Chantix causes a variety of psychological conditions, including suicides.

n Wednesday the Bedsole lawsuit became the lead bellwether, or test case, among those federal lawsuits. The trial is slated to begin Jan. 22 in Florence before U.S. District Judge Inge Johnson.

The Bedsole lawsuit reached that status Wednesday after Pfizer agreed to a settlement with Judy Ann Whitely, a Minnesota woman who blamed her husband's 2007 suicide on his use of Chantix. The trial in that case was to have begun Monday before Johnson.

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Pfizer Resolves Chantix Product-Liability Case Ahead of Trial

Quoted from http://professional.wsj.com/article/BT-CO-20121018-710407.html

Pfizer Resolves Chantix Product-Liability Case Ahead of Trial

By Peter Loftus

Pfizer Inc. (PFE) settled a product-liability lawsuit over its smoking-cessation drug Chantix, averting what would have been the first trial in the Chantix litigation.

The lawsuit "has been amicably resolved," according to an order Wednesday dismissing the case from U.S. District Judge Inge Prytz Johnson in the northern district of Alabama.

Terms of the resolution aren't being disclosed, said a Pfizer spokesman. Attorneys for the plaintiff couldn't immediately be reached.

A trial was scheduled to begin Monday in a lawsuit brought by a Duluth, Minn., woman alleging her husband's use of Chantix caused him to commit suicide in 2007. Judy Whitely accused Pfizer of failing to properly warn of the risks before her husband, Mark, began using Chantix, and she was seeking damages. Pfizer denied the allegations.

The case is one of more than 2,600 lawsuits in federal court containing accusations that use of Chantix caused suicides or other mental-health problems.

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Antidepressants linked to risk of brain bleeds

Quoted from http://www.reuters.com/article/2012/10/17/us-antidepressants-idUSBRE89G1PB20121017

Antidepressants linked to risk of brain bleeds

By Amy Norton

NEW YORK | Wed Oct 17, 2012 4:24pm EDT

NEW YORK (Reuters Health) - People using a common class of antidepressants may have slightly increased odds of suffering bleeding in the brain - though the risk is still very small, researchers reported Wednesday.

The antidepressants are known as selective serotonin reuptake inhibitors (SSRIs), and include widely used drugs like fluoxetine (Prozac), sertraline (Zoloft), citalopram (Celexa) and paroxetine (Paxil).

SSRIs have been linked to a risk of stomach bleeding. But studies have come to conflicting findings on whether SSRI users have any higher risk of hemorrhagic strokes, which happen when there is bleeding in or around the brain.

So for the new study, researchers pooled the findings from 16 past studies involving more than 500,000 people who were on SSRIs or not.

Overall, antidepressant users were about 40 to 50 percent more likely to suffer bleeding in or around the brain, the researchers report in the journal Neurology.

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Judge Denies Pfizer Request for Delay in Chantix Trial

Quoted from http://www.nasdaq.com/article/2nd-update-judge-denies-pfizer-request-for-delay-in-chantix-trial-20121016-01508

Judge Denies Pfizer Request for Delay in Chantix Trial

By Peter Loftus

A federal judge denied Pfizer Inc.'s (PFE) request to delay the start of the first product-liability trial surrounding its smoking-cessation drug Chantix, a delay the company said was needed because of newly released clinical data.

New York-based Pfizer is facing more than 2,600 lawsuits in federal court containing accusations that the smoking- cessation drug Chantix caused users to commit suicide or experience other mental-health problems, and that the drug maker failed to adequately warn of these risks. Safety concerns surrounding the drug have hurt its sales growth.

The first trial is scheduled to begin Monday in federal court in Alabama, and stems from a lawsuit brought by a Duluth, Minn., woman alleging her husband's use of Chantix caused him to commit suicide in 2007. Judy Whitely accused Pfizer of failing to properly warn of the risks before her husband Mark began using Chantix, and she is seeking damages.

Pfizer has denied the allegations, arguing in court papers that there is no evidence Chantix causes suicide-related events, and that it has properly warned of the various potential risks of the drug.

Tuesday, lawyers for Pfizer filed a motion seeking to delay the trial's start until Jan. 22, because the company released results Tuesday of a clinical trial involving Chantix. The study found Chantix was more effective than a placebo in helping people with past or present depression quit smoking, and there was no difference between the drug and a placebo in measures of psychiatric health, according to Pfizer's press release.

Pfizer asked a federal judge to delay the trial "to allow all parties to complete discovery and any pre-trial motion practice" related to the new clinical data, according to a motion filed by Pfizer Tuesday.

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Pfizer Appeals Court’s Order for CEO to Testify at Trial

Quoted from http://www.bloomberg.com/news/2012-10-11/pfizer-appeals-court-s-order-for-ceo-to-testify-at-trial.html

Pfizer Appeals Court’s Order for CEO to Testify at Trial

By Margaret Cronin Fisk - Oct 11, 2012 7:43 PM ET

Pfizer Inc. (PFE) appealed a judge’s order that Chief Executive Officer Ian Read testify in person at a federal trial over claims that use of its anti-smoking drug Chantix caused a Minnesota man to commit suicide.

The family of Mark Alan Whitely sued Pfizer after his death in November 2007, alleging the company failed to sufficiently warn that Chantix could increase the risk of suicide. The Whitely lawsuit is the first of more than 2,500 Chantix cases pending in federal court in Alabama to go to trial, according to court records.

U.S. District Judge Inge Johnson ordered Read and two other company executives to testify live at the trial, which is scheduled to begin Oct. 22 in Florence, Alabama. Pfizer asked the federal appeals court in Atlanta to erase her Oct. 4 order as “plainly beyond the court’s subpoena power.”

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Johnson & Johnson Agrees to Settle Five Rispersal Suits

Quoted from http://www.businessweek.com/news/2012-10-04/johnson-and-johnson-agrees-to-settle-five-rispersal-suits

Johnson & Johnson Agrees to Settle Five Rispersal Suits

By Sophia Pearson, Phil Milford and Jef Feeley on October 04, 2012

Johnson & Johnson (JNJ) agreed to settle five lawsuits over claims that its antipsychotic drug Risperdal caused increased breast-tissue growth in boys.

Terms of the settlements weren’t disclosed at a hearing today in Philadelphia Court of Common Pleas.

“Our clients are very pleased,” Steve Sheller, a plaintiffs’ attorney, said after the settlement was announced. “I’ll never be truly satisfied because of what happened here with these kids. It’s a sad commentary on what goes on with prescription drugs and their use in children.”

The lawsuits are among more than 400 in which J&J and its Janssen unit were accused of personal injuries caused by Risperdal, the company said in an August regulatory filing (JNJ). More than 100 involve claims that the drug caused young males to grow breasts, Sheller said.

The settlement covers cases that were planned for trial this year in Philadelphia, Janssen said in a statement e-mailed by spokeswoman Teresa Mueller.

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