Drug Safety Developments

Sanofi says experts find Lantus studies flawed

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSLF73372620090715

Sanofi says experts find Lantus studies flawed

Wed Jul 15, 2009 5:18am EDT

By Helen Massy-Beresford and Ben Hirschler

PARIS/LONDON, July 15 (Reuters) - Sanofi-Aventis said on Wednesday a group of independent experts had concluded that studies highlighting a possible link between its Lantus diabetes drug and an increased risk of cancer were flawed.

A multidisciplinary board of experts from the United States, France, Germany, Italy and Canada reached the conclusion after being asked by the French drugmaker to assess four studies published last month in the medical journal Diabetologia.

They found "significant methodological limitations and shortcomings" and said the results were "inconsistent and inconclusive".

But they added the important scientific questions raised called for further analysis of existing data on Lantus, as well as more basic and clinical investigations.

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Danish study looks at link between HRT, cancer

Quoted from http://www.reuters.com/article/healthNews/idUSTRE56D6S320090714

Danish study looks at link between HRT, cancer

Tue Jul 14, 2009 6:21pm EDT

By Andrew Stern

CHICAGO (Reuters) - Menopausal women who took hormone replacement therapy increased their risk of ovarian cancer by 38 percent, Danish researchers reported on Tuesday.

The study of more than 900,000 Danish women aged 50 to 79 found about one extra ovarian cancer for roughly 8,300 women taking hormone therapy each year.

At the time they got sick, 9 percent of the women were taking hormone therapy, 22 percent were previous users and 63 percent did not take it. The researchers calculated that current hormone use conferred a 38 percent higher risk of contracting the disease compared to non-users over the eight-year study.

Hormone therapy was linked to 140 extra cases of ovarian cancer in Denmark during the eight-year study, accounting for 5 percent of all cases in that period, the researchers reported in the Journal of the American Medical Association.

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Bayer Sued Over Safety of Popular Birth Control Pills

Quoted from http://www.law.com/jsp/article.jsp?id=1202432225980

Bayer Sued Over Safety of Popular Birth Control Pills

Tresa Baldas
The National Law Journal
July 14, 2009

First came the warning letter from the U.S. Food and Drug Administration; now it's lawsuits.

Bayer HealthCare Pharmaceuticals has been hit with four individual federal lawsuits -- three in Ohio, one in Wisconsin -- involving the safety of its popular birth control pills Yaz and Yasmin. And plaintiffs lawyers vow that plenty more are in the pipeline.

The back-to-back lawsuits -- which were filed on July 7, 9 and 10 -- come after Bayer reached an agreement with the Food and Drug Administration in 2008 to run a $20 million corrective ad campaign for overstating the benefits of Yaz and downplaying its risks. The FDA had issued Bayer a warning letter about the ads, noting that Yaz actually has additional risks compared to other birth control pills because it contains the progestin drospirenone, which can increase potassium levels.

Plaintiffs lawyers say the FDA letter will serve as handy evidence in their lawsuits, which allege that Bayer failed to warn women and their doctors of the pills' increased risk of injury -- most notably blood clots -- while overpromoting the benefits of the drugs.

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UPDATE:   Visit the YAZ, Yasmin, and Ocella Information page at our Drug Injury Law web site for more recent developments regarding personal injury and wrongful death lawsuits that involve YAZ, Yasmin, and Ocella.  (8/1/09)
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5 Risks Linked to Diabetes Medications Like Lantus, Avandia, Actos - US News and World Report

Quoted from http://health.usnews.com/articles/health/diabetes/2009/07/07/5-risks-linked-to-diabetes-medications-like-lantus-avandia-actos.html

5 Risks Linked to Diabetes Medications Like Lantus, Avandia, Actos

Cancer, heart failure, fractures, and eye and liver problems among some diabetes drugs' possible risks

By January W. Payne

 

Posted July 7, 2009

For the 200 million diabetics worldwide, the past few years have brought some disturbing findings about risks that may be associated with certain diabetes drugs. Recent concerns that Avandia (rosiglitazone) might cause cardiovascular problems, for example, have led some experts to call for it to be pulled from the market, although it remains available today. And in late June, studies published online by the journal Diabetologia raised questions about a possible link between the diabetes medication Lantus (insulin glargine) and an increased risk of cancer.

The safety worries about these diabetes medications come from scientific studies of varying designs. Some of the research, like that on Lantus and cancer, is based on observational data, which is not always reliable. The concern about Avandia, on the other hand, comes from clinical trials, which are the gold standard of research, and meta-analyses.

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Asthma drug linked to suicide attempts, thoughts of self-harm

Quoted from http://www.leaderpost.com/news/Asthma+drug+linked+suicide+attempts+thoughts+self+harm/1768232/story.html

Asthma drug linked to suicide attempts, thoughts of self-harm

By Bradley Bouzane, Canwest News Service July 7, 2009

OTTAWA — The side-effects of a popular asthma medication that has been sold in Canada for 12 years has been linked to suicide attempts and thoughts of suicide, as well as feelings of depression and hostility.

The July 2009 issue of the Canadian Adverse Reaction Newsletter from Health Canada cites montelukast sodium — which has been marketed in Canada since 1997 as Singulair — as having several connections to the alarming reactions.

Between its introduction to the Canadian market and Jan. 31, 2009, Singulair has been linked to two suicide attempts in Canada and 11 cases where users had thoughts of suicide or self-harm. In 29 other cases, 14 of which were labelled as "serious adverse reactions," those affected suffered from depression, hostility or other psychosis. No deaths have been linked to the drug's side-effects.

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Litigation Over Johnson & Johnson Antibiotic Levaquin Designated N.J. Mass Tort

Quoted from http://www.law.com/jsp/article.jsp?id=1202431984309&Litigation_Over_Johnson__Johnson_Antibiotic_Levaquin_Designated_NJ_Mass_Tort

Litigation Over Johnson & Johnson Antibiotic Levaquin Designated N.J. Mass Tort

Charles Toutant
New Jersey Law Journal
July 6, 2009

The New Jersey Supreme Court has designated mounting litigation over the Johnson & Johnson antibiotic Levaquin as a mass tort and has assigned it to an Atlantic County, N.J., judge. The suits charge that the drug, which is prescribed for bacterial infections of the lungs, urinary tract and skin, has caused Achilles' tendon ruptures and other damage....

Levaquin, made by J&J subsidiary Ortho-McNeil Pharmaceutical Inc., was approved by the Food and Drug Administration in 1996, but in July 2008, the FDA warned that Levaquin, and other drugs in the fluoroquinolone class of antibiotics, put users at heightened risk of developing tendonitis and tendon ruptures. The FDA ordered Ortho-McNeil to include on Levaquin's label a warning about the incidence of those injuries.

The most common injury associated with Levaquin, a ruptured Achilles' tendon, may require surgery to repair and frequently entails two months of immobility, then surgery and a rehabilitation period of six months or more....

Other reported injuries are ruptures of the rotator cuff, hand, biceps and thumb.

Most ailments occur during or soon after a course of Levaquin, although cases occurring several months after completion have been reported, and injuries are most frequent in users over age 60, people taking steroids, or persons who have had a kidney, heart or lung transplant, the plaintiffs allege.

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Two more Seroquel suits dismissed in Del.

Quoted from http://www.delawareonline.com/article/20090702/BUSINESS/90701085/1003/Two-more-Seroquel-suits-dismissed-in-Del.

Two more Seroquel suits dismissed in Del.

From wire reports • July 2, 2009

Two more cases have been dismissed in Delaware in the sprawling litigation over AstraZeneca's antipsychotic drug Seroquel, the drug maker said.

AstraZeneca said plaintiffs' attorneys have voluntarily dismissed the cases that were set to go to trial in November in Superior Court.

The dismissals follow a decision in May by Judge Joseph Slights III that an expert witness for another plaintiff failed to offer legally admissible testimony connecting her diabetes to her use of Seroquel. Following that decision, plaintiffs' attorneys voluntarily dismissed another case in Delaware.

AstraZeneca faces about 19,000 lawsuits nationwide from users of Seroquel who say the drug caused diabetes or related injuries.

More than 600 of those cases are pending in Delaware Superior Court.

Chantix, Zyban must carry depression warning

Quoted from http://www.msnbc.msn.com/id/31685329/ns/health-addictions/

Chantix, Zyban must carry depression warning

FDA to require smoking cessation drugs to warn of mental health risks

Video

FDA puts two drugs on suicide watch July 1: The FDA on Wednesday warned that anyone taking Chantix and Zyban should be watched closely for signs of mental illness because of a growing number of reports of suicide among patients who take the drugs. NBC's Brian Williams reports. Nightly News

updated 7:25 p.m. ET, Wed., July 1, 2009

NEW YORK - The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts.

The new requirement, called a “Black Box” warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.

The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC’s Zyban, already carries such a warning.

The FDA is also requiring an additional study on Chantix and Zyban to determine the extent of the side effects. Pfizer Inc., which makes Chantix, said it is still discussing the potential study design with the FDA. The study could include patients with and without psychiatric conditions to determine the true incidence rate of psychological side effects, Pfizer officials said.

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FDA plays down cancer link with Sanofi's Lantus

Quoted from http://www.reuters.com/article/healthNews/idUSTRE5605K620090701

FDA plays down cancer link with Sanofi's Lantus

Wed Jul 1, 2009 4:18pm EDT

By Lewis Krauskopf and Susan Heavey

NEW YORK/WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Wednesday cast doubt on recent studies that suggested possible cancer risk with Sanofi-Aventis' widely used Lantus diabetes drug, boosting investor confidence in the blockbuster product....

In a communication posted on its website, the agency questioned four recently published studies over the cancer link, saying they did not track patients long enough to properly evaluate any such risk from the drug.

Additionally, the FDA said, "inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of (Lantus) and cancer truly exists."

It added that there may be differences in the patients studied that could have contributed to the studies' findings.

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J&J, Abbott, Amgen Drugs Warrant Study, IOM Says

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=alY8uPuKA8vg

J&J, Abbott, Amgen Drugs Warrant Study, IOM Says

 

By Lisa Rapaport

June 30 (Bloomberg) -- Arthritis drugs that generated $16.9 billion last year for Amgen Inc., Wyeth, Abbott Laboratories and Johnson & Johnson warrant U.S. review as part of an Obama administration push to overhaul health care, a report said.

Outside advisers told the Department of Health and Human Services today that studies should compare the effectiveness of the drugs, including Remicade from J&J, and Enbrel, marketed by Wyeth and Amgen, in a family of medicines linked to cancer. ...

 

The U.S. Food and Drug Administration said last year it was investigating a possible association between Enbrel and Remicade and childhood cancer, following 30 cases of lymphomas in patients age 18 or younger who took the anti-inflammatory drugs.

The FDA began investigating cancer cases linked to the family of medicines, known as TNF blockers, which also includes Abbott’s Humira, more than 10 years ago. The prescribing information for all of the medicines already warns of cancer risks.

The FDA also added a so-called black box warning, its strictest, to Enbrel’s prescribing information last year describing links to deadly infections including tuberculosis and bacterial sepsis.

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