Drug Safety Developments

Canadians launch birth control lawsuit

Quoted from http://thegatewayonline.ca/articles/news/2010/11/29/canadians-launch-birth-control-lawsuit

Canadians launch birth control lawsuit

November 29, 2010 - 11:36pm

Megan Sarrazin, Intercamp (Grant MacEwan University)

EDMONTON (CUP) — Two brands of birth control pills prescribed to roughly two million women in 2009 are being named in a national class action lawsuit alleging serious health side effects to some of its users.

Yasmin and Yaz, both products of Bayer HealthCare Pharmaceuticals, are targets of the class action lawsuit by Siskinds, a law firm based in London, Ont.

According to Matthew Baer, the lead council representing Siskinds, they receive several calls a week from people noting injuries resulting from the use of Yasmin or Yaz.

"It just started getting overwhelming, the number of people calling with respect to this particular brand and so we started looking into it and seeing that there were a lot of issues in the U.S. as well."

"We started researching it more and it appears that there's science showing that the risks of serious injury with Yasmin and Yaz is worse than comparable contraceptives. But the warning that's given is that the risk is the same," said Baer.

Many of the reported side effects include strokes, pulmonary embolisms — a blood clot in the lung — and various heart problems. What Baer calls the most overwhelming, however, is that many young women have to get their gall bladders removed.

There have been about 4,000 individual cases against Yasmin and Yaz in the U.S. In addition, most provinces in Canada are filing class action lawsuits against the drugs, according to Baer.

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Darvon, Darvocet Will Be Withdrawn in U.S. Over Heart Risks, FDA Says

Quoted from http://www.bloomberg.com/news/2010-11-19/darvon-darvocet-will-be-withdrawn-in-u-s-over-heart-risks-fda-says.html?

Darvon, Darvocet Will Be Withdrawn in U.S. Over Heart Risks, FDA Says

By Molly Peterson - Nov 19, 2010 11:50 AM ET

Xanodyne Pharmaceuticals Inc. is pulling the prescription painkillers Darvon and Darvocet from the U.S. market, the Food and Drug Administration said.

The FDA asked the Newport, Kentucky-based company to withdraw the drugs because of heart risks, the agency said today in a statement. The FDA has requested that makers of generic versions of the active ingredient take them off the market.

That constituent -- propoxyphene, an opioid used to treat mild to moderate pain -- was approved by the FDA in 1957. New clinical data show the drug increases the risk of potentially fatal heart-rhythm abnormalities, the FDA said. Closely held Xanodyne sells propoxyphene as Darvon, and in combination with acetaminophen as Darvocet.

The data “suggested that the heart risk of propoxyphene could apply to all users, not just those who took excessive doses or those with medical conditions,” such as reduced kidney function, John Jenkins, director of the FDA’s Office of New Drugs, said today on a conference call.

About 10 million people in the U.S. received prescriptions for propoxyphene-containing products in 2009, said Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology, on the conference call.

“For the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” he said in the statement.

Users of the drug “need to know that these changes to the heart’s electrical activity are not cumulative,” he said. “Once patients stop taking propoxyphene, the risk will go away.”

Novartis Hid Risks to Protect Sales, Lawyer Says

Quoted from http://www.bloomberg.com/news/2010-11-19/novartis-hid-risks-to-protect-sales-lawyer-says-update1-.html

Novartis Hid Risks to Protect Sales, Lawyer Says

By Jef Feeley and Jerry Adams - Nov 18, 2010 7:05 PM ET

Novartis AG officials hid the health risks of the drugmaker’s bone-strengthening medicines Aredia and Zometa to protect billions of dollars in sales, lawyers for a North Carolina woman said.

Executives of Basel, Switzerland-based Novartis ignored studies showing that some cancer patients taking Aredia and Zometa may suffer irreplaceable jawbone damage, Vernon Glenn, a lawyer for Rita Fussman’s family, told a federal court jury in Winston-Salem, North Carolina. The drugs had $1.5 billion in sales in 2009.

Zometa and Aredia created a “giant money wheel” for Novartis, Glenn said in closing arguments of the trial of a lawsuit by Fussman’s family over damage done to her jaw. Novartis officials were prepared to do whatever it took to “keep the money wheel rolling,” the lawyer said.

The Fussman family’s lawsuit is the third product-liability case to go to trial over the bone-strengthening treatments. Last month, a New Jersey jury rejected a woman’s claims that Aredia and Zometa caused her jaw deterioration. In October 2009, a Montana jury ordered Novartis to pay $3.2 million in damages to a cancer patient who made the same claims over the medicines.

Bruce Berger, a Novartis lawyer, countered in his closing argument that the company provided adequate warnings about the risks the drugs posed to users. Fussman’s jaw problems were unrelated to her use of Zometa, he said. Fussman, who lived in Chapel Hill, North Carolina, died in 2009 of complications from breast cancer.

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Diabetes drug Avandia gets heart warnings

Quoted from http://www.cbc.ca/health/story/2010/11/18/avandia-warnings-canada.html

Diabetes drug Avandia gets heart warnings

Last Updated: Thursday, November 18, 2010 | 1:33 PM ET

CBC News

The diabetes drug Avandia now comes with warnings in Canada about heart risks, the drug's manufacturer said Thursday.

Canadians taking Avandia should make an appointment with their doctor as soon as possible about their treatment because of the Type 2 diabetes drug's potential risks, but not stop treatment abruptly, GlaxoSmithKline said.

The company, in consultation with Health Canada, announced new restrictions on the use of drugs containing rosiglitazone, such as Avandia, in people with Type 2 diabetes.

Package warnings say the drugs may increase the risk of serious heart problems, including heart failure, chest pain, heart attack and fluid retention.

The drugs should not be used in people who have or have had heart problems. People should talk to their doctor about other options before using the drug.

Based on Health Canada's review of recent data suggesting a higher risk of heart-related problems in patients treated with Avandia, the company has updated information for consumers and health-care professionals, including new restrictions on using the drug.

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Pfizer Unit Downplayed Prempro’s Risks, Lawyer Says

Quoted from http://www.bloomberg.com/news/2010-11-16/pfizer-unit-downplayed-prempro-s-risks-lawyer-says-update1-.htm

Pfizer Unit Downplayed Prempro’s Risks, Lawyer Says

By Jef Feeley - Nov 16, 2010 6:55 PM ET

Pfizer Inc.’s Wyeth unit downplayed the risks that its Prempro menopause drug could cause breast cancer, a lawyer for a Virginia woman who developed the disease told jurors.

Executives at Wyeth intentionally ignored researchers’ findings that the company’s hormone-replacement drugs might put women like Georgia Torkie-Tork at risk for the disease, Zoe Littlepage, one of her lawyers, told a federal court jury today in Alexandria, Virginia. The company also included ambiguous references to Prempro’s breast-cancer risks on the drug’s warning label, Littlepage said.

Wyeth’s scientists “never did a breast cancer study” on Prempro even though outside studies repeatedly uncovered “safety signals about the drug,” Littlepage said in opening statements.

More than 6 million women took the menopause drugs to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, topped $2 billion before the Women’s Health Initiative, a National Institutes of Health-sponsored study, concluded that they posed an increased risk of cancer.

Until 1995, many menopausal women combined Premarin, Wyeth’s estrogen-based drug, with Upjohn’s progestin-laden Provera, to relieve their symptoms. Wyeth later combined the two hormones in its Prempro pill.

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Johnson & Johnson Hid Antibiotic’s Risk, Lawyer Says

Quoted from http://www.bloomberg.com/news/2010-11-15/johnson-johnson-hid-risks-of-antibiotic-levaquin-lawyer-says-in-trial.html

Johnson & Johnson Hid Antibiotic’s Risk, Lawyer Says

By Margaret Cronin Fisk and Beth Hawkins - Nov 15, 2010 7:58 PM ET

Johnson & Johnson knew its antibiotic Levaquin increased the risk of tendon damage and failed to properly warn patients or doctors, a lawyer said today at the start of a trial in Minnesota.

John Schedin, 82, who said he ruptured the Achilles tendons in both feet after taking the drug, sued the company and its Ortho-McNeil-Janssen Pharmaceutical unit in 2008. The companies downplayed the risks of Levaquin even after receiving adverse reports from Europe in 2001, Schedin’s lawyer, Mikal Watts, said in his opening statement at trial today.

“The decision they made was to add a single line to the 14-page package insert somewhere on page four or five,” Watts told the Minneapolis jury. “They did not tell the doctors that the use of Levaquin concomitant with corticosteroids will cause an Achilles tendon to rupture.”

Schedin’s case is the first trial on more than 2,600 claims in U.S. courts against Johnson & Johnson that Levaquin caused tendon damage in patients taking the drug and the company failed to adequately disclose the risk. The U.S. Food and Drug Administration in 2008 required an upgraded warning on tendon damage posed by Levaquin and similar drugs.

The plaintiffs claim the warning should have been enhanced earlier and remains inadequate. They also claim Johnson & Johnson and Ortho-McNeil-Janssen boosted sales by downplaying risks.

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Surprise: JNJ Heart Drug Doesn’t Kill People. Or Do Much Of Anything.

Quoted from http://blogs.forbes.com/robertlangreth/2010/11/14/surprise-jnj-heart-drug-doesnt-kill-people-or-do-much-of-anything/

Surprise: JNJ Heart Drug Doesn’t Kill People. Or Do Much Of Anything.

Nov. 14 2010

By ROBERT LANGRETH

AHA 2010

A giant new study out today shows that a controversial Johnson & Johnson heart failure drug doesn’t kill people or cause serious kidney problems, as previous studies have suggested. But the study showed that the drug doesn’t seem to do all that much to help improve symptoms of acute heart failure, either.

The results should provide an end to the long and strange story of the J&J drug Natrecor. It rose to fame after it was approved based on a small study showing it appeared to help symptoms of patients reporting to the hospital with acute heart failure symptoms. Sales rose meteorically after some doctors started using it also in outpatient clinics in non-hospitalized patients. This was very profitable for both the doctors and for Johnson & Johnson.

But then sales dropped just as quickly after studies combed together the results of previous studies and showed that Natecor seemed to boost the risk of death. This led to a huge controversy over the widespread unproven “off-label” use in these outpatients.

The new 7000 patient showed the drug did not kill people, nor did it help very much in preventing symptoms either, when compared to patients that were treated aggressively with standard therapy. The modest symptom improvement was not statistically significant. “The drug does not have a long-term effect on clinical outcomes one way or another,” says Robert Califf of Duke University, who presented the big new study of 7000 patients at a news conference here at a meeting of the American Heart Association in Chicago.

The earlier study in 2005 showing a death risk “was wrong in its conclusion” that the drug killed people, admitted University of Michigan’s Keith Aaronson, who was involved in the earlier work showing a risk. This was not due to a technical flaw in the previous study, but just because the data available at the time was not rigorous enough to reach a definitive conclusion.

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FOX 5 Investigates: Singulair

Quoted from http://www.myfoxdc.com/dpp/news/investigative/fox-5-investigates-singulair-110810

Regular Photo Size

FOX 5 Investigates: Singulair

Updated: Tuesday, 09 Nov 2010, 12:40 AM EST
Published : Monday, 08 Nov 2010, 11:38 PM EST

 

By TISHA THOMPSON/myfoxdc

WASHINGTON - Kids so out of control, you can’t take them to church, the movies or even the mall. The problem may not be the kid or even their parents, but instead a popular drug prescribed to millions of kids across the country.

Singulair is drugmaker Merck’s number one selling drug, bringing in $4.6 billion last year. Doctors call it a miracle drug because it keeps kids with severe asthma and allergies out of the emergency room.

But there are a growing number of parents who say the risks associated with the drug could outweigh its benefits.

For kids with asthma, there’s nothing more exciting than running, especially when you’re trying to catch your big sister.

When he was just two years old, Willy Epperly started taking the asthma-allergy drug Singulair.

 

“We thought it was just a normal ‘terrible twos’ kind of thing,” said Willy’s mother Melissa.

 

She says in the beginning, it was subtle.

“By the time he got to pre-kindergarten, he was pushing children. He was yelling at the teacher. He wasn't sitting still. He wasn't following directions,” said Melissa. “I was literally afraid he was going to be kicked out of school."

Even Willy, who is now five years old, felt something wasn’t right.

“I got really mad at my body,” he said. “I tried to stop my body from doing bad things. I told it to stop, but it kept on doing it.”

When doctors told Melissa her son might have ADHD and might need even more medication, she decided to re-read Singulair’s packaging and discovered side-effects had been added in the years Willy was on the drug. Aggressive behavior, hostility, hallucinations, night-terrors, tremors, irritability, anxiety, depression and even suicide.

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Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial

Quoted from http://www.bloomberg.com/news/2010-11-09/glaxo-failed-to-warn-about-paxil-risks-lawyer-says-at-philadelphia-trial.html

Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial

By Jef Feeley - Nov 9, 2010 5:59 PM ET

GlaxoSmithKline Plc, the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors.

Glaxo had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about the deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury today. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said in opening statements. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

The Blyth family’s case is the first over Paxil’s birth- defect risks to go to trial since the company agreed in July to pay more than $1 billion to settle 800 cases alleging the company failed to adequately warn consumers and their doctors about the drug’s hazards. The Blyth case wasn’t part of the settlement.

In the first Philadelphia trial, a jury ordered Glaxo in October 2009 to pay $2.5 million to the family of a 3-year-old boy born with heart defects that his mother blamed on the drug.

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Pfleger's mother plans to sue contraceptive company Yaz

Quoted from http://www.elon.edu/pendulum/Story.aspx?id=4507

Pfleger's mother plans to sue contraceptive company Yaz

by Jack Dodson, November 4, 2010

Joan Cummins, the mother of Michelle Pfleger, the Elon University freshman who died at Elon University Sept. 24, has been talking to a lawyer and plans to sue Bayer HealthCare Pharmaceuticals Inc. on the grounds that its oral contraceptive Yaz caused the blood clots that led to her death.

Cummins started talking to the lawyer Oct. 29, after friends told her about cases they'd heard of people who had died because of using Yaz, which Pfleger had been taking for acne. She said at first, she needed to take a few weeks to grieve, but after a while, the idea became hard to ignore.

"Immediately after she died, everybody started talking," Cummins said. "I kind of had to talk a couple weeks and let it sink in."

Part of what surprised her when she started to research were Yaz's links to blood clots, which were the cause of Pfleger's death.

"She was completely healthy," Cummins said. The day before she died, Pfleger had been treated with an analgesic by a physician due to a knee injury. Cummins said it was a normal injury, which raised questions about where the clots came from.

This isn't the first time the company is being sued for blood clots allegedly caused by Yaz, according to BNET, a business news site affiliated with CBS. Attorneys in Ohio are gathering plaintiffs to sue the company for the same reason as Cummins.

Cummins said the legal process will be a long one, and her lawyer wants her to take it slow, but she wants something to focus on.

"She wants me to just kind of slow down a little bit, but I need something to put my energy into," Cummins said.