Drug Safety Developments

Pittsburgh Mother Joins Lawsuit Against Birth Control Pill

Quoted from http://www.thepittsburghchannel.com/news/21716101/detail.html

Pittsburgh Mother Joins Lawsuit Against Birth Control Pill

Mom Says Daughter Was Taking Yaz When She Fell Ill

PITTSBURGH -- A Pittsburgh-based drug company has been hit with a lawsuit claiming it misled women, including a local teenager whose mother says her daughter nearly died from birth control.

"She was short of breath, she was having severe chest pains and her face was changing colors," said Dana Kraus of her daughter.

Katie Kraus

Kraus said her 15-year-old daughter, Katie, had been taking the conceptive Yaz for about six months when the teen suddenly felt like she was suffocating.

"She ended up going into cardiac arrest three times. One time it took 10 minutes to revive her. They eventually had to do emergency surgeries because they noticed there were two huge blood clots, one in each pulmonary artery," said Kraus.

Kraus blamed Yaz and has joined a lawsuit against its holder, Pittsburgh-based Bayer Corporation.

Commercials for the contraceptive point out possible complications from taking the contraceptive and so does Bayer.

A representative for Bayer issued the following statement:

"The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all contraceptives. Bayer will defend itself vigorously against these lawsuits."

However the lawsuit claims women weren't warned properly and that side effects are actually 10 to 100 times more than reported.

"I just don't want anybody else to see their child go through anything like this ever again," said Kraus.

Katie Kraus survived, but her mother said Yaz has changed her daughter's life.

"She had pancreatitis, liver function problems, acute renal failure," said Kraus.

The lawsuit includes not only the Kraus, but several women who have made claims against Yaz, Yasmin and Ocella.

In the suit they have asked for a jury trial and more than $150,000 compensation, as well as punitive damages, attorney fees and the cost of the lawsuit.

Jury Awards $28 Million in Hormone-Therapy Suit

Quoted from http://online.wsj.com/article/SB10001424052748704779704574554152446529982.html

Award in Hormone Suit

By PETER LOFTUS

A jury awarded $28 million in punitive damages in Pennsylvania state court Monday to a plaintiff who claimed her use of Pfizer Inc.'s hormone-therapy drugs caused breast cancer.

The jury had awarded $6.3 million in compensatory damages on Friday to the plaintiff, Donna Kendall, of Decatur, Ill. The jury found that Pfizer units had engaged in a pattern of willful and reckless conduct. Wyeth was the primary seller of hormone-therapy drugs, and Pfizer recently acquired the company. A separate Pfizer unit, Upjohn, was a defendant in the case.

"We hope that the jury's verdict will send a message to these giant pharmaceutical companies that the safety and well being of the public must come before profits," said Tobias Millrood, Ms. Kendall's attorney, in a press release.

Pfizer spokesman Christopher Loder said the company would challenge the verdict in post-trial motions, or file an appeal if necessary. "The company believes that neither the award of punitive damages nor the liability verdict were supported by the evidence or the law," he said.

Separately, in the case of another woman, Connie Barton, who alleged use of the drugs caused breast cancer, a Pennsylvania jury last month ordered $75 million in punitive damages, after $3.7 million in compensatory damages. The amount of punitive damages had been confidential but was unsealed Monday. Together, juries in the two cases ordered Pfizer to pay more than $112 million in damages.

A major government study released in 2002 linked Wyeth hormone-therapy drugs, including Premarin and PremPro, which are used to treat menopausal symptoms, to increased risk for breast cancer and other injuries. As of mid-year, Wyeth was a defendant in some 8,200 legal claims in state and federal courts, brought by women who alleged their use of the drugs caused personal injuries.

U.S. lawsuit over Merck's Fosamax dismissed

Quoted from http://www.reuters.com/article/marketsNews/idUSN2326332120091123

U.S. lawsuit over Merck's Fosamax dismissed

NEW YORK, Nov 23 (Reuters) - A federal judge has dismissed a lawsuit alleging that Merck & Co's osteoporosis drug Fosamax causes jaw damage, more than two months after a jury deadlocked in a case involving a similar claim.

U.S. District Judge John Keenan on Monday found that Bessie Flemings, 74, a Mississippi resident, failed to present enough evidence to show that her use of Fosamax caused osteonecrosis of the jaw, or the death of jawbone tissue.

Keenan said Flemings' case was the second "bellwether" trial in nationwide litigation over Fosamax, which has spawned close to 900 lawsuits.

Robert Germany, a lawyer for Flemings, did not immediately return a call seeking comment. A Merck spokeswoman also did not immediately return a call seeking comment.

In afternoon trading, Merck shares were down 9 cents at $36.37 on the New York Stock Exchange.

The case is Flemings v. Merck & Co, U.S. District Court, Southern District of New York, No. 06-7631. The broader litigation in the same court is In re Fosamax Products Liability Litigation, No. 06-1789. (Reporting by Jonathan Stempel; Editing by Phil Berlowitz)

Pfizer Must Pay $6.3 Million in Damages Over Prempro

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aSn.sRk.QBKM

Pfizer Must Pay $6.3 Million in Damages Over Prempro

By Sophia Pearson and Jef Feeley

Nov. 20 (Bloomberg) -- Two Pfizer Inc. units’ hormone- replacement therapy drugs caused an Illinois woman’s breast cancer, making them liable for at least $6.3 million in damages, a Philadelphia jury ruled today.

Jurors deliberated about five hours before finding that the combination of Wyeth’s Prempro and Pharmacia & Upjohn’s Provera menopause drugs was a substantial contributing factor in Donna Kendall’s breast cancer. Kendall, 66, had a double mastectomy in 2002 after taking the hormone-replacement drugs for 11 years.

The panel will hear evidence Nov. 23 on whether Wyeth and Upjohn should pay punitive damages over their handling of the drugs. Wyeth has lost six of nine jury verdicts, including the last four in a row, over the drugs since 2006. This is Upjohn’s third loss at the jury stage. A trial judge threw out one verdict and another is on appeal.

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US FDA reviewing Abbott diet drug risks

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSN2024703020091120

US FDA reviewing Abbott diet drug risks

WASHINGTON, Nov 20 (Reuters) - U.S. regulators are reviewing preliminary data suggesting patients taking Abbott Laboratories Inc's weight loss drug Meridia may have a higher risk of cardiovascular problems, the Food and Drug Administration said on Friday.

"The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time," the agency said in a statement.

The FDA said early findings from a recent study suggested patients taking Meridia may have a higher number of cardiovascular-related problems, including heart attacks, strokes, cardiac arrests and deaths, when compared to patients who took a placebo. (Reporting by Lisa Richwine; editing by Carol Bishopric)

AstraZeneca’s Seroquel Study Found No Diabetes Link

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=alauRiKV7MRQ

AstraZeneca’s Seroquel Study Found No Diabetes Link

By Jef Feeley and Margaret Cronin Fisk

Nov. 19 (Bloomberg) -- A study by AstraZeneca Plc found “no significant” link between the company’s antipsychotic drug Seroquel and the onset of diabetes, an expert witness said at a pre-trial hearing on lawsuits over the product.

Dr. Paul D. Woolf, a Philadelphia-based doctor who specializes in treating diabetes, told a judge today that his review of a 2004 AstraZeneca study measuring Seroquel’s diabetes risk showed the drug didn’t significantly affect patients’ blood-sugar levels. AstraZeneca officials want to call Woolf to testify in upcoming trials to counter consumers’ allegations that the medicine causes diabetes in some users.

“There was no glucose deterioration in the study’s Seroquel-treated population,” Woolf told U.S. District Judge Anne Conway in Orlando, Florida. Conway is overseeing all federal litigation over the drug.

The company faces more than 14,000 suits in U.S. state and federal courts alleging AstraZeneca officials hid Seroquel’s diabetes risk. The drug, which generated sales of $4.45 billion in 2008, is AstraZeneca’s second-biggest seller after the ulcer treatment Nexium.

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U.S. panel rejects Xolair asthma drug for children

Quoted from http://in.reuters.com/article/governmentFilingsNews/idINN1812824820091118

U.S. panel rejects Xolair asthma drug for children

 

By Ben Hirschler

SILVER SPRING, Md., Nov 18 (Reuters) - Roche  and Novartis's asthma drug Xolair should not be approved for children aged 6 to 11, a U.S. advisory panel decided on Wednesday.

Although the drug has shown modest benefits in treating children with particularly bad asthma in clinical tests, experts were concerned about the drug's safety and the possibility of a long-term cancer link.

Xolair has been cleared since 2003 for use by adults and adolescents aged 12 and older. Roche and Novartis are eager to also offer it in the important U.S. children's market -- but the panel's decision means this is now unlikely.

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AstraZeneca Judge to Urge Return of Seroquel Cases to Courts

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aQj__0MXVggc

AstraZeneca Judge to Urge Return of Seroquel Cases to Courts

By Jef Feeley and Margaret Cronin Fisk

Nov. 19 (Bloomberg) -- AstraZeneca Plc may face as many 6,000 trials of lawsuits claiming its antipsychotic drug Seroquel causes diabetes after a judge said she will recommend sending the cases back to their home courts.

U.S. District Judge Anne Conway in Orlando, Florida, who is overseeing pre-trial proceedings in federal Seroquel litigation, said yesterday she’ll urge a panel of judges to return all of the cases to courts across the U.S. for possible trials.

AstraZeneca, the U.K.’s second-largest drugmaker, wanted Conway to send as many as 60 suits back to their home courts for trial as test cases. Lawyers for former users contended they were ready to press forward on their claims that the London- based company downplayed Seroquel’s diabetes risk.

Conway’s ruling “will get the litigation moving,” Paul Pennock, a lawyer for former Seroquel users, said in an interview. “The decision will help get a huge group of cases to a state of trial-worthiness.”

The company faces more than 14,000 suits in U.S. state and federal courts alleging Seroquel caused diabetes in some users. Seroquel, which generated sales of $4.45 billion in 2008, is AstraZeneca’s second-biggest seller after the ulcer treatment Nexium.

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US FDA staff question Pfizer lung drug data

Quoted from http://www.reuters.com/article/latestCrisis/idUSN17544425

US FDA staff question Pfizer lung drug data

By Lisa Richwine

WASHINGTON, Nov 17 (Reuters) - U.S. reviewers will ask an advisory panel about statistical issues and safety concerns as they weigh a proposed new claim for a lung drug sold by Pfizer Inc and Boehringer Ingelheim, documents released on Tuesday said.

The companies are asking the Food and Drug Administration for permission to claim the drug Spiriva reduces flare-ups of chronic obstructive pulmonary disease (COPD).

Spiriva is currently considered the gold standard treatment for COPD, or "smoker's lung," commonly caused by cigarette smoke and other harmful fumes and characterized by a persistent obstruction of airflow in the lungs which results in breathlessness.

It is approved for treating COPD but not specifically for reducing flare-ups, a claim made by GlaxoSmithKline's competing drug Advair.

FDA reviewers, in an analysis prepared for an outside advisory committee, said in two Boehringer studies of Spiriva "there are statistical issues with consideration of an exacerbation claim, which may preclude a single trial from supporting the claim."

The agency also said it will ask the panel at a meeting on Thursday to consider recent safety concerns surrounding the possibility of strokes, cardiovascular-related deaths and heart attacks with Spiriva, a daily inhaled medicine.

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US FDA sees varying risk from MRI agents

Quoted from http://www.reuters.com/article/marketsNews/idCNN1737499420091117

US FDA sees varying risk from MRI agents

 

By Lisa Richwine

WASHINGTON, Nov 17 (Reuters) - Some contrast agents used with magnetic resonance imaging scans appear to carry a higher risk of a potentially fatal skin disease than others, U.S. drug reviewers said in documents released on Tuesday.

The Food and Drug Administration said a staff review found the highest risk of the skin disease, nephrogenic systemic fibrosis (NSF), was associated with GE Healthcare's Omniscan, Bayer AG's Magnevist and Covidien's Optimark.

The lowest risk was associated with Prohance and Multihance, made by Bracco Diagnostics, the agency said, adding "the data do not appear to rule out an NSF risk for each of the agents."

The agency said the staff review that found variations among the drugs had limitations and it would take the issue to a panel of outside experts that meets in December.

The products, used to help make MRI scans easier to read, have been given to millions of patients. They are members of a family known as gadolinium-based imaging agents. The FDA announced in 2007 it was requiring a strong "black box" warning on all of the drugs to alert physicians that patients with certain kidney and liver conditions were at risk for for NSF.

Staff in the FDA's drug safety unit said the magnitude of the risk "does not compel removal of specific (imaging agents) from the U.S. market" but recommended that the drug labels note the varying levels of risks with each product.

NSF triggers thickening of the skin, organs and other tissues that makes it difficult to move and can lead to broken bones, although the exact cause is unclear. There is no effective treatment.

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