Drug Safety Developments

Sanofi to probe cancer link with insulin use

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSLT1221420090929

Sanofi to probe cancer link with insulin use

PARIS, Sept 29 (Reuters) - Sanofi Aventis on Tuesday launched a research plan to probe the safety of insulin, including its Lantus diabetis drug.

The research program is designed to generate more information on whether there is any association between cancer and insulin use and to assess if there is any difference in risk between insulin glargine -- such as Lantus -- and other insulins.

Sanofi-Aventis said its scientific programme and studies will be initiated in the coming weeks.

Timelines for study completion and data generation will vary depending on each type of study.

In June, the European Association of the Study of Diabetes journal Diabetologia published a critical study discussing the drug at its annual meeting.

Prescription data showed demand for the long-acting insulin was holding up, despite the release of studies suggesting a possible link between Lantus and cancer, while U.S. and European regulators have both backed the product. (Reporting by Marcel Michelson; Editing by Hans Peters)

Merck’s Appeal of Vioxx Award Thrown Out, Firm Says

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aRtMmiDIMi4g

Merck’s Appeal of Vioxx Award Thrown Out, Firm Says

By Jef Feeley and David Voreacos

Sept. 29 (Bloomberg) -- Merck & Co.’s appeal of a $4.5 million jury award to a New Jersey man who blamed his heart attack on the company’s Vioxx painkiller was dismissed by an appeals court, lawyers for the man’s family said.

The New Jersey Supreme Court threw out the drugmaker’s challenges to the 2006 jury verdict for John McDarby, who died while the case was on appeal, the Weitz & Luxenberg PC law firm said today in a statement. The court’s decision means Merck will have to pay at least $4.5 million in damages to McDarby’s family, his lawyers said....

Merck, which is set to buy rival Schering-Plough Corp. by the end of the year, won 11 of 16 Vioxx suits at trial before agreeing in 2007 to create a $4.85 billion settlement fund to resolve thousands of injury claims related to the drug. The company is based in Whitehouse Station, New Jersey.

Company executives are “considering their options” in the wake of the court’s decision, Ron Rogers, a Merck spokesman, said in a telephone interview today.

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Bayer’s Yaz Consumer’s Death Probed By Swiss Agency

Quoted from http://www.bloomberg.com/apps/news?pid=20601085&sid=aPSvNPx7m.n4

Bayer’s Yaz Consumer’s Death Probed By Swiss Agency

By Karin Matussek

Sept. 26 (Bloomberg) -- Bayer AG, Germany’s largest drugmaker, said its Yaz contraceptive is part of an investigation by a Swiss health regulator into the death of a young woman who took the pill.

The Swissmedic agency and an investigative judge are looking into the case of the woman, who died from the effects of pulmonary embolism, Bayer’s Swiss health unit said in a statement posted on its Web site yesterday. Bayer is cooperating with the authorities, the company said.

“A singular case, as tragic and sad as it is, does not indicate an increased risk for the whole group of women who take the pill,” Oliver Renner, a Berlin-based spokesman for Bayer, said in an interview today. “Studies have shown that the risk isn’t higher for Yaz than for other oral contraceptives.”

Leverkusen, Germany-based Bayer’s Yasmin, Yaz and Yasminelle contraceptives brought in $1.86 billion for Bayer in the first quarter, and Yasmin and Yaz are the two biggest- selling contraceptives worldwide, according to IMS Health Inc., a Norwalk, Connecticut-based market research company.

Bayer will also probe the matter, said Renner. In a case like that, the company routinely conducts its own investigation, he added.

The regulator was alerted to the “sudden” death of the woman, who had been taking the contraceptive for ten months, Swissmedic said on its Web site. Thromboembolic complications are well known yet rare side-effects of hormone-based contraceptives and the risk is also increased during pregnancy, the agency said.

Yaz contraceptive pill to stay on the market

Quoted from http://worldradio.ch/wrs/news/wrsnews/yaz-contraceptive-pill-to-stay-on-the-market.shtml?16084

Yaz contraceptive pill to stay on the market

Monday, 28 September, 2009, 15:15

A contraceptive pill, which contains a compound suspected of causing the recent death of a young woman and leaving another seriously ill, will not be removed from the market.

The medicines supervisor, Swissmedic, says that the Yaz pill is no more dangerous than other contraceptives which contain Drospirenone.

Tests have been carried out on Yaz, Yasmin and Yasminelle pills, all produced by the German company Bayer, the results of which will be released next month.

However, Swissmedic said today that they estimate that the three drugs ‘don’t pose any particular risk.’

US FDA eyes possible risk with Novartis iron drug

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSN2541611920090925

US FDA eyes possible risk with Novartis iron drug

WASHINGTON, Sept 25 (Reuters) - U.S. health officials are looking into whether patients with a certain bone marrow disorder are more at risk for death and serious complications with Novartis AG's drug Exjade.

Those with myelodysplastic syndrome (MDS) may have a higher risk of kidney failure, potentially fatal bleeding and death with use of the drug, which helps regulate iron levels in patients who receive regular blood transfusions, the U.S. Food and Drug Administration said on Friday.

In a notice on its website, the agency said it was investigating reported complications in patients using the drug but that several factors make it difficult to draw any conclusions without a closer look.

Patients who had serious side effects were typically older, the FDA said. They also may have had other medical problems which could be a factor, the agency said. Problems seemed fewer in younger patients with other chronic anemia conditions.

Novartis, in a statement, said it was working with the FDA "to further review and clarify the population of MDS patients most appropriate for treatment with Exjade." It is working with the FDA over how to present the information on the drug's label.

The FDA said it would issue its final conclusions when it concluded its analysis of all the data. In the meantime, patients should talk to their doctors, it said.

Exjade has already been linked to other, potentially fatal side effects such as kidney and liver failure, among other conditions, according to the agency.

Shares of Novartis closed up 9 cents at $48.86 on the New York Stock Exchange. (Reporting by Susan Heavey; Editing by Carol Bishopric)

Health Concerns Are Raised Over Use of Popular Contraceptives

Quoted from http://www.nytimes.com/2009/09/26/health/26contracept.html

Health Concerns Over Popular Contraceptives

By NATASHA SINGER Published: September 25, 2009

The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare largely as a result of marketing that presents them as much more than mere pregnancy prevention.

Yaz, in particular, the top-selling birth control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a quality-of-life treatment to combat acne and severe premenstrual depression.

Yaz, a newer sister drug to Yasmin, contains less estrogen. The franchise had worldwide sales of about $1.8 billion last year, based on Bayer’s successful positioning of Yasmin and Yaz as the go-to drug brands for women under 35.

But recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do.

Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills.

But regulators are finding other faults with the Yaz franchise. The Food and Drug Administration early this year asked Bayer to correct misleading television commercials. Last month, the agency cited the company for not following proper quality control procedures at a plant that makes hormone ingredients.

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Wyeth’s Prempro Caused Woman’s Cancer, Jury Decides

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=ahQt5ddXvk5Y

Wyeth’s Prempro Caused Woman’s Cancer, Jury Decides

By Sophia Pearson

Sept. 25 (Bloomberg) -- Wyeth’s hormone-replacement therapy drug Prempro caused an Illinois woman’s invasive breast cancer and she deserves $3.7 million, a jury decided in Philadelphia, without yet deciding whether the company was at fault and should pay her.

Jurors deliberated about two hours and 15 minutes before concluding that Wyeth’s drug was a proximate cause of Connie Barton’s breast cancer. Barton, 64, was diagnosed with cancer in 2002, five years after she began taking Prempro to treat menopausal symptoms.

Jurors will hear arguments on Wyeth’s liability and possible punitive damages at a second phase of the trial starting on Oct. 1. Wyeth, which is being acquired by Pfizer Inc., has said that it faces more than 9,000 lawsuits over its menopause drugs, along with Pfizer’s Pharmacia & Upjohn unit.

The company has now lost five of eight trials over its hormone-replacement drugs since cases began reaching juries in 2006. Some of the verdicts were set aside, and others are on appeal. This is the company’s third straight loss.

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US FDA sees pancreatitis link with Merck's Januvia

Quoted from http://www.reuters.com/article/governmentFilingsNews/idUSN2550919420090925

US FDA sees pancreatitis link with Merck's Januvia

 

WASHINGTON, Sept 25 (Reuters) - U.S. health officials said on Friday they suspect Merck & Co Inc's diabetes drug Januvia may be linked to serious cases of pancreatitis, but company officials disputed the connection.

The Food and Drug Administration said that 88 cases of acute pancreatitis had been reported since the drug's approval in 2006 through February 2009.

Because a number of patients developed the condition soon after taking Januvia, or related drug Janumet, and about half saw it disappear after they stopped using it, "FDA believes there may be an association" with the drug.

But Dr. John Amatruda, a Merck senior vice president for diabetes products, said "We don't believe that the data establishes a relationship."

Both Januvia and Janumet contain the active ingredient sitagliptin.

The FDA said it was working with Merck to add information about the cases to the drugs' labels. (Reporting by Susan Heavey; Editing by Tim Dobbyn)

Merck Paying More Than 3,100 Vioxx Death Claims

Quoted from http://www.bloomberg.com/apps/news?pid=20601202&sid=aGPA3PzDf1Rs

Merck Paying More Than 3,100 Vioxx Death Claims

By David Voreacos, Jef Feeley and Dawn McCarty

Sept. 25 (Bloomberg) -- Merck & Co. is paying claims by the families of more than 3,100 users of its Vioxx painkiller who died of heart attacks or strokes blamed on the drug, according to a law firm administering a $4.85 billion settlement fund.

The fund will pay about 3,000 claims for heart attack deaths and at least 122 strokes, according to BrownGreer LLP, a claims administrator appointed by both sides. Merck introduced Vioxx in 1999 and withdrew it in 2004 when a study showed the drug doubled the risk of heart attacks and strokes. Merck set up the fund, which covers claims of death and lesser injuries, in 2007 after reserving $1.9 billion to fight 26,600 Vioxx suits.

“We don’t know any drug right now with this number of deaths associated with it,” said Houston attorney Mark Lanier, a Vioxx plaintiffs’ lawyer who is appealing the reversal of a $256 million verdict against Merck. “This is a very sad chapter in the American tragedy of pharmaceutical companies gone wild.”

Merck, which is set to buy rival Schering-Plough Corp. by the end of the year, won 11 of 16 Vioxx suits at trial before agreeing to settle all claims. Under the accord, the facts of each case determine the extent of Merck’s liability, which analysts once estimated to be as much as $20 billion overall. BrownGreer said it’s almost done reviewing 48,507 claims. So far, the firm has rejected 40 percent of them.

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AstraZeneca Denied Drug’s Diabetes Link Years After Warning

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aTC6jrBl_mwM

AstraZeneca Denied Drug’s Diabetes Link Years After Warning

By Jef Feeley and Margaret Cronin Fisk

Sept. 23 (Bloomberg) -- An AstraZeneca Plc saleswoman told a U.S. doctor the antipsychotic Seroquel didn’t cause diabetes almost four years after the company warned Japanese physicians about the drug’s links to the disease, internal documents show.

Nancy White, the saleswoman, and a colleague met with an unidentified doctor in July 2006 who reported “getting a lot of flak” from patients about Seroquel’s diabetes links, according to a note unsealed as part of a lawsuit. AstraZeneca wrote in November 2002 to Japanese doctors that it received a dozen reports of diabetes-related cases tied to Seroquel “where causality with the drug could not be ruled out.”

White said in the 2006 note that she told the physician that “there has been no causative effect” found between Seroquel and diabetes. The doctor “said he would not quit writing” prescriptions for Seroquel “due to this at this time,” White reported.

More than 15,000 patients have sued London-based AstraZeneca, claiming the company withheld information about links between diabetes and Seroquel. Many of the suits also claim AstraZeneca promoted Seroquel, approved by the U.S. Food and Drug Administration for schizophrenia and bipolar disorder, for unapproved uses.

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