Drug Safety Developments

Philadelphia Jury Finds for Wyeth in Hormone Replacement Therapy Case

Quoted from http://www.law.com/jsp/article.jsp?id=1202444500915

Philadelphia Jury Finds for Wyeth in Hormone Replacement Therapy Case

The verdict disrupts the streak of plaintiffs' wins before Philadelphia Common Pleas Court juries in HRT mass tort cases

Amaris Elliott-Engel

The Legal Intelligencer

February 25, 2010

After more than six hours of deliberation, a Philadelphia jury unanimously returned a defense verdict Wednesday in a lawsuit alleging that a hormone replacement therapy drug caused breast cancer in an Indiana woman who died of the disease.

The verdict in favor of drugmaker Wyeth came because the jury found a lack of factual causation of Cheryl Foust's disease by her use of the HRT drug Prempro.

The defense in Foust v. Wyeth, however, did not get all of the answers it wanted on the questions presented to the jury.

The jury found that Wyeth negligently failed to adequately warn Foust's prescribing nurse practitioners about the risk of Prempro, and that the negligent failure to warn was a causation factor in the nurse practitioners prescribing Prempro to Foust.

In an unusual aspect of the case, Foust's identical twin sister, Carol, took an HRT drug but did not get breast cancer. Both the plaintiffs and the defense sought to use Carol Foust's lack of cancer to their advantage in making arguments to the jury.

[Article continues at original source]

A Face-Off on the Safety of a Drug for Diabetes

Quoted from http://www.nytimes.com/2010/02/23/health/23niss.html

A Face-Off on the Safety of a Drug for Diabetes

By GARDINER HARRIS

Published: February 22, 2010

Three years ago, Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales and a plunge in the share price of GlaxoSmithKline, Avandia’s maker.

_______________________________________________________________________________

Related:

Research Ties Diabetes Drug to Heart Woes

(February 20, 2010)

_______________________________________________________________________________

The battle between Dr. Nissen and GlaxoSmithKline was waged from afar in news releases and published papers. But on May 10, 2007, 11 days before Dr. Nissen’s study was published in The New England Journal of Medicine, he and four company executives met face to face in a private meeting whose details have not been disclosed until now.

Fearing he would face pressure and criticism from executives, Dr. Nissen secretly recorded the meeting — which is legal in Ohio as long as one party to the conversation is aware of the taping. On a recent day in his sunny office at the Cleveland Clinic, Dr. Nissen shared the contents of the recording with The Times.

What was said at the 2007 meeting raises questions about science and ethics that have suddenly become keenly relevant....

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Pfizer Must Pay $9.45 Million in Damages Over Prempro

Quoted from http://www.businessweek.com/news/2010-02-22/pfizer-must-pay-9-45-million-in-damages-over-prempro-update1-.html

Pfizer Must Pay $9.45 Million in Damages Over Prempro

February 22, 2010

By Sophia Pearson and Jef Feeley

Feb. 22 (Bloomberg) -- Pfizer Inc.’s Wyeth unit was ordered to pay $6 million in punitive damages to an Alabama woman who developed breast cancer after taking the company’s menopause drugs, bringing the total award in the case to $9.45 million.

A Philadelphia state-court jury deliberated a few minutes before deciding that Wyeth should pay $6 million as punishment for failing to warn Audrey Singleton, a retired school bus driver from Chatom, Alabama, of the risks of the drug. The jury ruled earlier today that the company owed Singleton and her husband $3.45 million in compensatory damages.

“The verdict is not supported by the facts and the law and we will be challenging it through all appropriate means post trial and on appeal,” Heidi Hubbard, an attorney for Wyeth, said after the verdict.

The verdict is Wyeth’s seventh loss in 10 cases to have gone before juries and the fifth in a row over the drug. Former users have filed more than 8,000 complaints against Wyeth and another Pfizer unit over menopause drugs, according to a Wyeth regulatory filing last year. The drugs are still on the market.

[Article continues at original source]

AstraZeneca Hid Seroquel’s Risk, Lawyer Tells Jurors

Quoted from http://www.businessweek.com/news/2010-02-22/astrazeneca-hid-seroquel-s-risk-lawyer-tells-jurors-update1-.html

AstraZeneca Hid Seroquel’s Risk, Lawyer Tells Jurors

February 22, 2010

By Jef Feeley and Margaret Cronin Fisk

Feb. 22 (Bloomberg) -- AstraZeneca Plc hid the diabetes risks of the antipsychotic drug Seroquel, a lawyer for a former user suing the company told a New Jersey jury in the first case to go to trial over the medicine.

Ted Baker, a Vietnam War veteran, took the drug to deal with lingering symptoms of post-traumatic stress disorder and wasn’t properly warned about its risks, his lawyer Jerry Kristal said today in state court in New Brunswick, New Jersey. The case is among about 26,000 over similar claims.

AstraZeneca buried warnings about Seroquel’s links to diabetes under a list of other possible side effects in the drug’s label, Kristal said in opening statements in the trial, which is scheduled to last at least three weeks.

“There were about 175 things listed before you got down to diabetes,” including hiccups, chills and hemorrhoids, he said.

[Article continues at original source]

Diabetes Drug Avandia Harms the Heart, Studies Find

Quoted from http://www.nytimes.com/2010/02/20/health/policy/20avandia.html

Research Ties Diabetes Drug to Heart Woes

By GARDINER HARRIS

 Published: February 19, 2010

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.

The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.

[Article continues at original source]

FDA raises safety warning on Novartis iron drug

Quoted from http://www.reuters.com/article/idUSN1821050820100218

FDA raises safety warning on Novartis iron drug

Thu Feb 18, 2010

NEW YORK, Feb 18 (Reuters) - A boxed warning highlighting serious safety concerns, including reported deaths, with the use of Novartis AG's Exjade drug to remove excess iron from the blood, has been added to the medicine's label, the U.S. Food and Drug Administration said.

In a message on its website, the FDA said the prescribing information for Exjade would now carry a highlighted warning, often called a black box, noting that the drug may cause renal impairment, including kidney failure; hepatic impairment, including liver failure; and gastrointestinal hemorrhage.

In some reported cases, the agency said, the reactions were fatal.

Exjade is approved to treat chronic iron overload due to blood transfusions. The drug works by binding to excess iron and removing it from certain cells in the body, such as liver cells, before being excreted.

But the drug has been under scrutiny by health regulators over safety concerns.

In September, the FDA said it was looking into whether patients with myelodysplastic syndromes -- bone marrow disorders often requiring blood transfusions -- were at higher risk of serious complications or death when using the Novartis drug.

The FDA said reported serious adverse reactions cited in the new warning were more frequently observed in higher risk patients. It cited patients of advanced age, those with high risk myelodysplastic syndromes, underlying kidney or liver impairment or those with low blood platelet counts.

The agency said Exjade therapy requires close patient monitoring.

"The label updates announced today will enhance the ability of physicians to appropriately treat patients who are prescribed or taking Exjade to manage transfusional iron overload," Novartis said in a statement.

"The core information in the boxed warning is not new but provides more specifics about which patients may be at the greatest risk and offers specific monitoring guidance," Novartis said, adding that it would send a letter to healthcare professionals to ensure that they are aware of the updated warnings.

Glaxo Shares Fall After FDA Finds Asthma Drug Risk

Quoted from http://www.bloomberg.com/apps/news?pid=20601202&sid=aYFsIoFmXyPw

Glaxo Shares Fall After FDA Finds Asthma Drug Risk

By Molly Peterson

Feb. 19 (Bloomberg) -- GlaxoSmithKline Plc declined in London trading after U.S. regulators warned against long-term use of the company’s best-selling product, the Advair asthma treatment, and called for further study of potential health risks.

Advair and AstraZeneca Plc’s Symbicort combine drugs from a class known as long-acting beta agonists with inhaled corticosteroids. The agonists have been linked to increased risk of worsening asthma symptoms, hospitalizations and deaths, the Food and Drug Administration said yesterday. Use should stop once symptoms are under control, the agency said. The warning may curb U.S. sales of the medicines and hamper development of a new compound for lung disease Glaxo is working on with Theravance Inc., said Mark Purcell and Brian Bourdot of Barclays Capital.

“The FDA language may be ambiguous, but the intent seems clear,” Purcell and Bourdot wrote in a note to clients today. It appears “the FDA would like to see LABA use come down.”

The agency advised against using products containing long- acting beta agonists alone. An outside panel will meet next month to gather information on how to design studies for the combination drugs, the FDA said in a statement.

[Article continues at original source]

AstraZeneca Faces First Trial Over Seroquel Diabetes Claims

Quoted from http://www.bloomberg.com/apps/news?pid=20601202&sid=a.qMy6.XdEo4

AstraZeneca Faces First Trial Over Seroquel Diabetes Claims

By Jef Feeley and Margaret Cronin Fisk

Feb. 18 (Bloomberg) -- AstraZeneca Plc faces its first jury trial in the U.S. over claims its antipsychotic drug Seroquel causes diabetes as juror selection began in a New Jersey state courthouse.

Those selected to sit on the panel in the New Brunswick court today will hear a Vietnam War veteran’s lawsuit against AstraZeneca, the U.K.’s second-largest drugmaker. Ted Baker contends he developed diabetes after taking Seroquel to deal with lingering symptoms of post-traumatic stress disorder and wasn’t properly warned about the drug’s risks. His case is the first to go to trial of about 26,000 such claims over Seroquel.

Lawyers for London-based AstraZeneca will try to persuade jurors that Seroquel didn’t contribute to Baker’s diabetes and the drugmaker didn’t hide its health risks, said Dan Carlat, a psychiatrist at Tufts University School of Medicine in Boston who writes about antipsychotics drugs.

“The question is whether the links between Seroquel and diabetes are strong enough to convince a jury the drug is at fault,” Carlat said in an interview. Seroquel, with sales of $4.9 billion last year, is the company’s second-biggest seller after the ulcer treatment Nexium.

[Article continues at original source]

Family Claims Birth Control Pill Killed College Student

Quoted from http://www.newschannel5.com/global/story.asp?s=11964317&nav=menu374_2

Family Claims Birth Control Pill Killed College Student

Posted: Feb 10, 2010

 

By Ben Hall

NASHVILLE, Tenn. - There are a growing number of lawsuits across the country from women claiming to have been harmed by the birth control drug, Yaz.

The latest involves the death of a local college student who had been taking YAZ for six months.

"She was all about laughing and having fun," said Traci Mayfield of her 20-old-daugher Leah. "We were more than mother/daughter, we were best friends."

Leah and her mom spoke every day even though Leah was hours away attending college at Tennessee Tech in Cookeville.

"She blossomed into a beautiful young lady up there. You can just see the transformation in pictures," said Mayfield.

By Leah's junior year she was a leader in her sorority, on the Dean's list and on her way to becoming a nurse.

"They would call her mama Leah, just as a joke. If anybody was sick, if anybody wasn't feeling good - they would call Leah," said Mayfield.

Suddenly last January, it was Leah who needed help.Her roommate called 911 for an ambulance after Leah passed out in the shower.

"Is she awake now?" asked the 911 operator.

"She's awake now. She's breathing really hard and very very pale, like very pale," said Leah's roommate.

The roommate then called Leah's mom and put Leah on the phone.

"Leah told me that she was scared, and that she was tingling all over. I told her it was going to be okay, that me and daddy was coming," said Mayfield.

Leah's mom and dad did not make it in time. Leah died less than an hour later after the call.

"You go in the room and there's your child, your baby girl lying on the stretcher," said Mayfield as she wiped away tears.

Doctors said Leah died because of a blood clot in her lung. The official cause of death was a pulmonary embolism.

"How does this happen to a healthy 20 year old young lady?" asked Leah's mom.

The Mayfields never expected the answer they received. An emergency room doctor said the birth control pill Leah started taking six months before, called YAZ, could have caused the blood clot.

[Article continues at original source]

US reviewing risks of Roche, Novartis, Biogen drugs

Quoted from http://www.reuters.com/article/idUSN1719273020100217

US reviewing risks of Roche, Novartis, Biogen drugs

Wed Feb 17, 2010

WASHINGTON, Feb 17 (Reuters) - U.S. health regulators are reviewing potential risks of medicines from Roche Holding AG , Novartis AG and other companies.

The Food and Drug Administration said on Wednesday it was probing reports of hearing loss with Novartis cancer drug Gleevec, hypothermia with Roche's flu drug Tamiflu and pericarditis with Biogen Idec and Elan Corp's multiple sclerosis drug Tysabri.

The FDA releases a quarterly list of safety probes to inform the public about early investigations of potential side effects that have been reported. The lists released on Wednesday covered issues identified between April 2009 and September 2009. More than two dozen drugs were listed.

Others included rheumatoid arthritis drugs known as tumor necrosis factor (TNF blockers) for reports of demyelinating neuropathy, a neurological disorder. The FDA did not name specific TNF blockers, but the drug include Amgen and Pfizer's Enbrel, and Abbott Laboratories Inc's Humira.

Being on the list "does not mean that FDA has identified a causal relationship between the drug and the listed risk," the FDA said.

Officials at the drugmakers had no immediate comment or could not immediately be reached.

The FDA posted the lists here and here.