Drug Safety Developments

Fordham Professor To Lead Fosamax Settlement Talks

Quoted from http://www.law360.com/health/articles/288052/fordham-professor-to-lead-fosamax-settlement-talks

Fordham Professor To Lead Fosamax Settlement Talks

By Erin Fuchs

Law360, New York (November 28, 2011, 3:22 PM ET) -- A New York federal judge last week chose a Fordham University School of Law professor as a special master tasked with brokering a settlement of roughly 900 suits consolidated in a multidistrict litigation alleging Merck & Co. Inc.'s Fosamax causes jaw deterioration.

U.S. District Judge John Keenan on Nov. 22 appointed John D. Feerick, formerly dean of Fordham's law school, as special master, noting that the plaintiffs' steering committee and Merck had agreed to his appointment.

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Yasmin birth control lawsuit a 1st in Canada

Quoted from http://www.cbc.ca/news/health/story/2011/11/25/yasmin-mersereau-suit.html

Yasmin birth control lawsuit a 1st in Canada

CBC News

Posted: Nov 25, 2011 3:38 PM ET

 

The relatives of a woman who died in Toronto after taking Yasmin birth control pills have launched the first individual civil lawsuit against the drug manufacturer in Canada.

Vicky Caprice Mersereau, 26, died in 2009 of a large pulmonary embolism after she ingested Yasmin, the legal firm Siskinds LLP said in a statement to CBC News.

Yasmin, which is made by Bayer Inc., is one of Canada's top-selling birth control pills. It is a so-called "fourth generation" hormonal contraceptive and is considered "low dose."

The announcement of the suit, launched Friday in London, Ont., comes ahead of the U.S. Food and Drug Administration's public hearings on the oral contraceptive scheduled for Dec. 8 in Maryland.

The FDA's reproductive health and drug safety committee will be looking at the safety of Yasmin and its unique progestin, drospirenone.

Last month, the FDA warned that oral contraceptives containing the hormone drospirenone, and sold in Canada under the name Yasmin (or its sister pill Yaz), increase the risk of blood clots by 74 per cent, compared with older pills on the market.

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Bayer May Have Pitched Birth-Control Pill for Unapproved Uses

Quoted from http://www.bloomberg.com/news/2011-11-21/bayer-may-have-touted-birth-control-pills-for-unapproved-use-e-mails-show.html

Bayer May Have Pitched Birth-Control Pill for Unapproved Uses

By Jef Feeley and Margaret Cronin Fisk - Nov 21, 2011 4:00 AM ET

Units of Bayer AG (BAYN), Germany’s largest drugmaker, may have sought to market the Yasmin family of birth- control pills for unapproved uses and mislead women about the health risks the drug posed, according to company e-mails.

Bayer unit officials discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome, according to company files provided to lawyers for women suing Bayer. U.S. regulators approved Yaz only for the most severe form of PMS. Salespeople for Bayer unit Berlex Laboratories Inc., acquired in the 2006 purchase of Schering AG, received an e-mail that year from a company official citing a Woman’s Day magazine article about Yaz.

“This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific” class of women battling premenstrual dysphoric disorder, the most severe form of PMS, wrote Matt Sample, a Berlex sales consultant, according to a copy of the e-mail.

The message and other internal company files were disclosed as part of litigation claiming the drug caused blood clots, heart attacks and strokes. Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives. Lawyers suing the drugmaker cited Food and Drug Administration reports of at least 50 deaths tied to the pills from 2004 to 2008.

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Sanofi’s Multaq Doubled Deaths From Heart Disease in Study

Quoted from http://www.bloomberg.com/news/2011-11-14/sanofi-s-multaq-doubled-deaths-from-heart-disease-in-study.html

Sanofi’s Multaq Doubled Deaths From Heart Disease in Study

By Michelle Fay Cortez and Robert Langreth - Nov 14, 2011 12:30 PM ET

Sanofi’s Multaq, approved to treat patients whose hearts intermittently race with quick and inefficient contractions, doubled the risk of death in those with a permanent form of the erratic rhythm, a study found.

Stroke and heart failure rates also rose significantly in those given Multaq during the trial of 3,236 patients, a blow for the drug that doctors thought would avoid the risks seen with earlier generations of anti-arrhythmic drugs. The research was halted in July because of the increased danger, and the results were presented today at the American Heart Association’s annual meeting in Orlando, Florida.

Doctors had hoped the drug’s ability to reduce deaths, strokes and hospitalizations in patients with occasional atrial fibrillation would carry over to those with the more serious form of the condition, said lead researcher Stuart Connolly, from the Population Health Research Institute in Hamilton, Ontario. The findings shoot down the hypothesis, he said.

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Boehringer says about 260 deaths related to Pradaxa

Quoted from http://www.reuters.com/article/2011/11/12/boehringer-pradaxa-idUSL5E7MC09K20111112

Boehringer says about 260 deaths related to Pradaxa

FRANKFURT | Sat Nov 12, 2011 8:06am EST

FRANKFURT Nov 12 (Reuters) - Boehringer Ingelheim said that 260 cases of fatal bleeding have been linked to its new stroke prevention pill Pradaxa so far, adding that the risk of death was still below the rate that emerged in the clinical trial that led to the drug's approval.

In early November, the German drugmaker had said that 50 reported deaths were a "reasonable order of magnitude".

The company on Saturday confirmed in a statement the new global number more than five times higher than the previous one, initially reported by magazines Der Spiegel and Die Zeit.

Like other anti-blood-clotting treatments, Pradaxa's benefit of cutting the rate of fatal or debilitating strokes comes at the risk of internal bleeding, which can also cost lives.

Unlisted Boehringer also said there have been fewer cases of fatal side effects linked to Pradaxa than what would have been expected if they had been treated by the standard drug warfarin, which Boehringer is trying to replace.

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Study opposes routine use of bone drug for breast cancer

Quoted from http://news.cincinnati.com/article/20111110/LIFE07/311100023/Study-opposes-routine-use-of-bone-drug-for-breast-cancer

Study opposes routine use of bone drug for breast cancer

Nov. 9, 2011 

 

Kathleen Doheny | HealthDay

The bone drug Zometa, once considered a promising weapon to reduce the risk of breast cancer recurrence, should not be used routinely in treatment of the disease, researchers say.

In a study of breast cancer patients, Zometa (zoledronic acid) did not increase disease-free survival overall, and it appeared to raise the risk of a serious side effect, said Dr. Robert Coleman, the study’s co-author and a professor of medical oncology at the University of Sheffield in England.

However, “for the one-third of women in the study who had gone fully through menopause at the time of study entry, there is significant benefit in terms of both disease recurrence and overall survival,” Coleman said.

Women receiving hormone therapy for breast cancer treatment are prone to weakening and thinning of the bone, a condition known as osteoporosis, so they often receive bone-building drugs known as bisphosphonates.

Some previous research had suggested these bone drugs might also help to prevent recurrence of breast cancer.

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Glaxo Facing Mediation Push to Resolve Avandia Lawsuits

Quoted from http://www.bloomberg.com/news/2011-11-08/glaxo-facing-mediation-push-to-resolve-avandia-lawsuits-1-.html

Glaxo Facing Mediation Push to Resolve Avandia Lawsuits

By Jef Feeley - Nov 8, 2011 3:34 PM ET

GlaxoSmithKline Plc (GSK), which has agreed to pay $3 billion to resolve claims it illegally marketed its Avandia diabetes drug, is facing a judge’s push to resolve most of the remaining patient lawsuits over the medication.

U.S. District Judge Cynthia Rufe said yesterday she appointed a mediator to “preside over settlement negotiations” for an unspecified number of Avandia cases consolidated before her in Philadelphia. Rufe set a 75-day deadline to resolve 85 percent of the remaining cases, according to court filings.

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Newer birth control pills again tied to blood clots

Quoted from http://www.reuters.com/article/2011/11/07/us-birth-control-clots-idUSTRE7A66R320111107

Newer birth control pills again tied to blood clots

By Amy Norton

NEW YORK | Mon Nov 7, 2011 6:12pm EST

NEW YORK (Reuters Health) - A study out Monday adds to evidence that a newer type of birth control pill may carry a higher risk of blood clots than older versions.

The study, of 330,000 Israeli women, found that those who used birth control pills with the hormone drospirenone -- found in brand-names like Yaz and Yasmin -- were more likely than other Pill users to develop blood clots called venous thromboembolisms.

Overall, there were just over six cases of venous blood clots per 10,000 Pill users each year in the study. But the risk was 43 percent to 65 percent higher with drospirenone-containing pills, compared with older, so-called second- and third-generation pills.

That increased risk would translate to about eight to 10 clots per 10,000 women per year.

Venous thromboembolisms most commonly form in the leg veins, but can travel to the lungs, where they cause a pulmonary embolism.

It has long been known that women on the Pill have a small, although higher-than-average risk of blood clots. But recent studies have suggested the risk may be relatively higher with pills containing drospirenone -- which include Yaz, Yasmin, Beyaz and Safyral, along with their generic equivalents.

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FDA’s AERS provides surprising look at statin class side effects, study shows

Quoted from http://www.modernmedicine.com/modernmedicine/Clinical+Pharmacology/FDArsquos-AERS-provides-surprising-look-at-statin-/ArticleStandard/Article/detail/747172

FDA’s AERS provides surprising look at statin class side effects, study shows

Publish date: Nov 4, 2011
By: Formulary staff
Source: Formulary News Capsules

Findings culled from a new method for aggregating and making sense of data in the FDA’s Adverse Event Reporting System (AERS) present a surprising glimpse at the postmarketing adverse event data for statins.

The study, which was conducted by AdverseEvents, Inc., using their proprietary new data sourcing method, RxFilter, found a class-wide variation in muscle-related adverse event reports. The results linked rosuvastatin (Crestor, AstraZeneca) with the highest percentage risk in 6 categories, including myopathy (general), myalgia, myositis, rhabdomyolysis, joints and tendons, muscle atrophy and injury, and muscle coordination and weakness. Pravastatin (Pravachol, Bristol-Myers Squibb) and lovastatin (Mevacor, Merck) demonstrated the best muscle-related safety profile.

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New study says Chantix raises suicide risks

Quoted from http://www.reuters.com/article/2011/11/02/us-smoking-drug-idUSTRE7A181220111102

New study says Chantix raises suicide risks

By Julie Steenhuysen

CHICAGO | Wed Nov 2, 2011 5:46pm EDT

CHICAGO (Reuters) - Pfizer's smoking cessation drug Chantix carries too many risks and should only be tried when other treatments fail, researchers said on Wednesday.

Chantix was eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch, they said.

 

The findings contradict two studies released last month by the Food and Drug Administration that showed Chantix (sold as Champix outside the United States) did not increase the risk of being hospitalized for psychiatric problems such as depression.

The agency at the time acknowledged that those studies were flawed because they were too small to identify rare events and they only captured cases that were severe enough to land people in the hospital.

"Our study contradicts the implications of a recent review by the FDA showing no difference in psychiatric hospitalizations between varenicline and nicotine replacement patches," said Dr. Curt Furberg, professor of Public Health Sciences at Wake Forest Baptist Medical Center, co-author of the study published online in the Public Library of Science journal PLoS One.

"The FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression and assaults. These can be catastrophic events but do not normally result in hospitalization," Furberg said in a statement.

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