Drug Safety Developments

Lilly’s Effient Tied to More Cancer Risk Than Plavix

Quoted from http://www.businessweek.com/news/2010-06-28/lilly-s-effient-tied-to-more-cancer-risk-than-plavix.html

Lilly’s Effient Tied to More Cancer Risk Than Plavix

June 28, 2010, 7:39 PM EDT

By Ellen Gibson

June 28 (Bloomberg) -- Eli Lilly’s blood-thinner Effient was linked to higher rates of cancer than Bristol-Myers Squibb Co.’s rival product Plavix, research published today found.

Patients taking Effient had a 43 percent higher rate of solid tumors, excluding some skin cancers and brain tumors, than those who received Plavix, according to the analysis of previously unpublished data that appeared today in the Archives of Internal Medicine. The rate of solid tumors, other than brain and some skin cancers, was 1.4 percent of Effient patients compared with 0.9 percent of those on Plavix.

Indianapolis-based Lilly is counting on Effient to replace lost revenue after its top-seller, the antipsychotic Zyprexa, faces generic competition in 2011. However, initial sales of the drug have been “disappointing,” wrote Christopher Schott, a pharmaceuticals analyst at JPMorgan Chase Bank, in a note today to investors today. Effient pulled in $29 million in revenue last year. Plavix, the world’s second-biggest selling medicine, generated $9.5 billion in global sales for New York-based Bristol-Myers and Paris-based Sanofi-Aventis SA.

“Some of the enthusiasm for the drug has already worn off, but this is very concerning,” said James Floyd, a postdoctoral fellow in cardiovascular health at the University of Washington in Seattle and one of the paper’s authors, in a telephone interview. “The main message to the FDA is, let’s make sure this thing doesn’t cause cancer if you’re going to keep it on the market.”

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Bayer drops one infringement case v Teva over Yaz

Quoted from http://www.reuters.com/article/idUSN2913835620100629

Bayer drops one infringement case v Teva over Yaz

Tue Jun 29, 2010 11:06am EDT

By Tom Hals

WILMINGTON, Del., June 29 (Reuters) - Bayer AG (BAYGn.DE) withdrew one lawsuit against Israeli drugmaker Teva Pharmaceutical Industries Ltd (TEVA.TA)(TEVA.O), which it accused of infringing Bayer's Yaz oral contraceptive drug, but said it would continue to press its claims.

The German drugmaker said in a Monday filing in Delaware District Court it was dropping its lawsuit, which also named Teva subsidiary Barr Laboratories Inc as a defendant.

However, Bayer said in a statement it plans to continue to pursue its patent infringement case against Teva's generic version of Yaz, also known as Gianvi, in Nevada District Court.

"Bayer is committed to vigorously enforcing its intellectual property and continues to pursue its patent infringement case filed earlier against Teva in Nevada," Bayer said in a statement.

The complaint in Delaware District Court was filed on June 1, and had asked the court for an injunction to prevent Teva, the world's largest maker of generic drugs, from selling its generic version of Yaz, or Gianvi.

On June 7, Bayer filed a similar complaint in Nevada, where it had already brought complaints against Watson Laboratories (WPI.N) and Sandoz Inc. Sandoz is a unit of Swiss drugmaker Novartis AG (NOVN.VX).

Bayer had said in court papers that Nevada was the appropriate venue because it "will eliminate the risk of inconsistent adjudications."

Two weeks ago, Bayer said Teva's U.S. business admitted in court that some of the information included on Gianvi packages was false and agreed to correct its labeling.

Teva declined to comment.

Bayer stock was down 4 percent in Frankfurt trading. Teva's shares were little changed at $51.32 on the Nasdaq.

The Delaware case is Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc v Teva Pharmaceutical Industries Ltd and Teva Pharmaceuticals USA Inc, Barr Pharmaceuticals LLC and Barr Laboratories Inc, U.S. District Court, District of Delaware, No. 10-cv-00474.

The Nevada case is Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc v Teva Pharmaceutical Industries Ltd and Teva Pharmaceuticals USA Inc, Barr Pharmaceuticals LLC and Barr Laboratories Inc, U.S. District Court, District of Nevada, No. 10-cv-00872.

Diabetes Drug Avandia Poses Safety Test For FDA

Quoted from http://www.npr.org/templates/story/story.php?storyId=128174678

Diabetes Drug Poses Safety Test For FDA

by Richard Knox

June 29, 2010

 

Justin Sullivan/Getty Images

In this photo illustration, bottles of Avandia diabetes medication are seen at Jack's Pharmacy on May 21, 2007, in San Anselmo, Calif.

The Obama administration is facing its first big decision about whether to remove a drug from the market. The issue raises questions not only about the particular drug -– a diabetes pill called Avandia –- but also about the administration's philosophy on these hotly contested public safety calls.

On July 13 and 14, the Food and Drug Administration will have a full-dress debate about the safety of Avandia, a drug taken by hundreds of thousands of Americans with diabetes.

In the run-up to that debate, researchers have published two new studies that add to the growing evidence that Avandia raises the risk of heart attacks, strokes and cardiovascular death.

One of the new studies, the largest done so far on Avandia, was commissioned by the FDA; its results were published online by the Journal of the American Medical Association.

The study looks at what happened when nearly 230,000 Medicare recipients took either Avandia or a related drug, Actos. Dr. David Graham of the FDA, the study's lead author, says the results were alarming.

"If you treated 60 people for a year with Avandia, you would cause one extra case of heart attack, stroke, heart failure or death," Graham says, "compared to if you had treated 60 patients with Actos."

That's a substantial difference. Graham says it means nearly 50,000 elderly Americans have died or had heart attacks, strokes or heart failure due to Avandia since the drug came on the market in 1999. Add in those younger than 65, the number is probably 100,000, Graham says.

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Top-selling birth control pill in U.S.: Miracle drug or poison pill?

Quoted from http://www.komonews.com/news/problemsolvers/97368859.html

Top-selling birth control pill in U.S.: Miracle drug or poison pill?

By Tracy Vedder

Summary

Yaz and Yasmin have become the most widely-prescribed birth control pill in the U.S. But the drugs are also generating a flood of complaints and more than a thousand lawsuits over deaths and serious injuries.

Story Published: Jun 28, 2010 at 11:50 PM PDT

Story Updated: Jun 29, 2010 at 7:03 AM PDT

Depending on who you listen to, it's either a new miracle drug or a poison pill.

One thing's for certain: it's become the most widely-prescribed birth control pill in the U.S. But as the Problem Solvers discovered, many claim it is killing young, healthy women.

Laura Strothers, a dental hygienist in Smokey Point, works confidently most of the time, her hands steady and firm. But whenever she can, she avoids using her left hand, even asking her dental patients to hold her tools at times.

Strothers suffered a debilitating injury a year ago. She figures she's lucky she didn't die. After all, her life changed overnight.

"My left arm was completely swollen, purple, cold to the touch," she said.

Doctors found a life-threatening blood clot in a major vein, but the diagnosis made no sense.

"I'm a healthy 30-year-old," said Strothers, who had none of the known risk factors for blood clots.

But one thing was different.

"There was nothing to explain it except the Yasmin birth control," Strothers said.

Like millions of women, Strothers fell for a media blitz advertising the birth control pill, Yasmin. Together with its newest form, Yaz, it's become, in just a few years, the top-selling oral contraceptive in the U.S.

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Two New Studies Cite Heart Risk in Glaxo's Avandia

Quoted from http://online.wsj.com/article/SB10001424052748703964104575334570859778764.html

Two New Studies Cite Heart Risk in Glaxo's Avandia

JUNE 29, 2010

By ALICIA MUNDY And JENNIFER CORBETT DOOREN

Two new studies released Monday said the diabetes drug Avandia is unsafe, heating up a controversy about a drug linked in a number of studies to an increased risk of heart attack and heart failure.

Avandia Diabetes Drug Controversy Heats Up

2:54

Two studies suggest there's an increased risk of heart attack, stroke or heart failure among those taking diabetes drug Avandia, WSJ's Alicia Mundy reports.

The reports were presented in the Journal of the American Medical Association and its sister publication, the Archives of Internal Medicine. They come two weeks before an important Food and Drug Administration meeting on Avandia's safety. In releasing the papers together, a JAMA spokeswoman said the editors "hope the peer-reviewed scientific studies will have some impact on the FDA's discussions about the safety of this medication."

The studies also coincided with the American Diabetes Association's annual meeting in Orlando.

Avandia manufacturer GlaxoSmithKline PLC said in a statement that the drug, which lowers blood glucose, is safe and effective. Glaxo said it looks forward to a "rigorous scientific discussion" about the new studies at the FDA meeting.

One study in the Archives of Internal Medicine is an update of a 2007 analysis of the clinical trials done on Avandia by Steven Nissen, a cardiologist at the Cleveland Clinic. The original analysis was based on 42 studies involving Avandia and showed a 43% increase in the risk of heart attacks. The new analysis looks at 56 clinical studies, including a Glaxo-funded study known as Record, and shows an increased heart attack risk of 28%. If the Record study is removed from the analysis, the risk of heart attacks rises to 39%.

The second study, published in JAMA, was led by FDA drug-safety scientist David Graham, and looked at the outcomes of nearly 230,000 Medicare patients who were treated with Avandia or Actos, a similar drug made by Takeda Pharmaceutical Co. The study looked at a combined endpoint of heart attack, stroke, heart failure or death and found that patients taking Avandia had an 18% increased risk compared to those taking Actos.

Dr. Graham has argued that it should be withdrawn from the market.

"I think these studies ought to weigh heavily on the advisory panel," Dr. Nissen said in an interview.

An analysis of data from a third study, called Bari 2D and funded by the government, didn't show cardiovascular risks. The results, which haven't been peer-viewed and published yet, were released early at the diabetes conference in response to the JAMA studies.

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Drugmaker Merck says it will fight $8 million compensatory damages verdict in Fosamax trial

Quoted from http://www.startribune.com/business/97182699.html

Drugmaker Merck says it will fight $8 million compensatory damages verdict in Fosamax trial

By LINDA A. JOHNSON , Associated Press

Last update: June 25, 2010 - 5:04 PM

TRENTON, N.J. - Drugmaker Merck & Co. said it will challenge its first loss in a trial blaming its osteoporosis drug for destroying a patient's jawbone after a federal jury on Friday awarded $8 million to the Florida woman.

The U.S. District Court jury in New York awarded that amount in compensatory damages to Shirley Boles, 72, of Fort Walton, Fla., who alleged Merck's Fosamax destroyed her jawbone near her ears, causing serious pain and disability.

"She feels vindicated, absolutely vindicated," said her attorney, Timothy O'Brien.

The three-week trial ended after nearly four hours of deliberations Friday by a jury of three men and four women. It was the second for Boles, a retired sheriff's deputy in the sex crimes unit in Oskaloosa County, Fla. Her first trial ended last September in a mistrial.

The jury concluded that Fosamax was "unreasonably dangerous due to defective design, and that its defective design was a legal cause of Mrs. Boles' injury."

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No pancreatitis risk seen in Byetta, Januvia drugs-study

Quoted from http://blogs.reuters.com/lewis-krauskopf/2010/06/27/no-pancreatitis-risk-seen-in-byetta-januvia-drugs-study/

No pancreatitis risk seen in Byetta, Januvia drugs-study

Jun 27, 2010 12:29 EDT

NEW YORK, June 27 (Reuters) – Two widely used diabetes
medicines, Januvia and Byetta, pose no additional risk for
cases of inflamed pancreas compared with other diabetes drugs,
according to an analysis of medical claims data released on
Sunday.

The study could boost Januvia, sold by Merck & Co (MRK.N: Quote, Profile, Research),
and Byetta, from Amylin Pharmaceuticals Inc (AMLN.O: Quote, Profile, Research) and Eli
Lilly & Co (LLY.N: Quote, Profile, Research). Both drugs are important products for the
companies but have faced concerns that they are linked to acute
pancreatitis, which can be life threatening.

The study also found that diabetics generally are at
increased risk of acute pancreatitis, compared with
non-diabetics, which the study’s author said confirmed previous
research, although the risk remains very low.

The analysis was conducted by pharmacy benefit manager
Medco Health Solutions (MHS.N: Quote, Profile, Research), in association with the
University of Texas Southwestern Medical School. Medco, which
manages benefits and tries to lower drug bills for employers,
insurers and other clients, is conducting studies using its
vast medical claims database as it seeks to raise its profile
as a clinical company.

Dr. Merri Pendergrass, who conducted the study,
acknowledged that it was an observational study of data, as
opposed to the gold standard of a randomized clinical trial.

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Jury orders Merck pay $8 million Fosamax damages

Quoted from http://www.reuters.com/article/idUSTRE65O5HG20100625

Jury orders Merck pay $8 million Fosamax damages

NEW YORK Fri Jun 25, 2010

NEW YORK (Reuters) - A jury on Friday awarded $8 million in compensatory damages to a Florida woman who sued Merck & Co, alleging the company's osteoporosis drug Fosamax damaged her jaw, nine months after the first lawsuit ended in a mistrial.

Shirley Boles, 71, of Walton Beach, Florida, sued Merck in 2006, claiming she suffered dental and jaw problems because she took Fosamax from 1997 to 2006.

"Today's verdict is just the first step, but it's important because the jury found that Merck defectively designed the drug," Boles's attorney Tim O'Brien said in a statement.

Merck said in a statement that it would challenge the verdict.

A month-long trial in Manhattan federal court in August and September last year was Merck's first out of some 1,280 plaintiff groups involving almost 900 U.S. lawsuits by patients who claim Fosamax caused the condition known as osteonecrosis of the jaw, or death of jawbone tissue.

The second trial that began on June 7 before U.S. District Judge John Keenan ended on Friday with a verdict in favor of Boles that the company said was contrary to the evidence presented at trial.

"Both the finding and the amount of the compensatory damages are against the weight of the evidence," Bruce Kuhlik, executive vice president and general counsel said in a statement. "We believe the evidence showed that FOSAMAX did not cause the plaintiff's injury and that it is a safe and effective medication that was properly designed."

The statement cited another verdict before the same court in May in favor of the company.

Merck shares were up 32 cents at $35.93 on the New York Stock Exchange.

The case is In re Fosamax Products Liability Litigation, U.S. District Court, Southern District of New York (Manhattan), No. 06-1789.

Paxil Litigation Over Birth Defects Shifts to Settlement

Quoted from http://www.law.com/jsp/article.jsp?id=1202462916664

Paxil Litigation Over Birth Defects Shifts to Settlement

Amaris Elliott-Engel

The Legal Intelligencer

June 23, 2010

Drugmaker GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects.

Only one case in Philadelphia's mass tort Paxil program has gone to trial.

GSK has settled every other case scheduled for trial in the eight months since a Philadelphia jury awarded a $2.5 million plaintiffs verdict in the first Philadelphia Paxil test case to go to trial.

GSK started to appeal that plaintiffs verdict from October. The jury awarded only compensatory damages and no punitive damages. But GSK then decided to settle Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline along with another 190 cases, according to an order signed by Philadelphia Common Pleas Judge Sandra Mazer Moss last week.

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What Allergan doesn't want to you know about Botox

Quoted from http://www.ocregister.com/news/botox-254083-allergan-company.html

What Allergan doesn't want to you know about Botox

Published: June 18, 2010
Updated: June 19, 2010 8:20 p.m.

By COLIN STEWART THE ORANGE COUNTY REGISTER

Allergan, manufacturer of the blockbuster cosmetic drug Botox, has downplayed information about the drug's dangers to avoid alarming consumers, according to public documents, court testimony and evidence revealed by recent lawsuits that allege severe or fatal reactions.

Botox is the world's most popular wrinkle-fighting drug, producing sales of $1.3 billion a year for Allergan. It is also an icon of social division in the United States. A person's attitude toward the drug is a litmus test that distinguishes people who are willing to go to great lengths to preserve their youthful looks from people who look down on artificial methods of fighting the effects of aging.

Dr. Sharla Helton, of Oklahoma City, won a $15 million lawsuit against Allergan over the side effects of Botox, which she says left her in constant pain and partially paralyzed. A jury agreed that Allergan had failed to disclose potential side effects. The company is appealing. JOHN CLANTON, SPECIAL TO THE ORANGE COUNTY REGISTER

In that social context, Irvine-based Allergan doesn't want consumers to focus on any possible ill effects of Botox or on the fact that it is derived from a toxin that causes paralysis.

"Botox Cosmetic is not a poison and is not botulism. It is a purified protein and a finished medical prescription product," Allergan's marketing materials state.

Yet Botox is a weakened version of what the Journal of the American Medical Association calls "the most poisonous substance known." Four-hundredths of an ounce of undiluted botulinum toxin is enough to kill a million people with the paralyzing nerve disease botulism.

Company officials say it's important that people not become so worried about the potential risks of Botox that they lose sight of its benefits.

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