Pharmaceutical Drug Litigation Updates

Could Statins Raise Diabetes Risk?

Quoted from http://news.health.com/2013/05/23/could-statins-raise-diabetes-risk/

Could Statins Raise Diabetes Risk?

May 23, 2013

 

THURSDAY, May 23 (HealthDay News) — Certain statins — the widely used cholesterol-lowering drugs — may increase your chances of developing type 2 diabetes, a new study suggests.

The risk was greatest for patients taking atorvastatin (brand name Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor), the study said.

Focusing on almost 500,000 Ontario residents, researchers in Canada found that the overall odds of developing diabetes were low in patients prescribed statins. Still, people taking Lipitor had a 22 percent higher risk of new-onset diabetes, Crestor users had an 18 percent increased risk and people taking Zocor had a 10 percent increased risk, relative to those taking pravastatin (Pravachol), which appears to have a favorable effect on diabetes.

Physicians should weigh the risks and benefits when prescribing these medications, the researchers said in the study, which was published online May 23 in the journal BMJ.

[Article continues at original source]

Antibiotic Zithromax label to warn of potential heart side-effect

Quoted from http://www.cbc.ca/news/health/story/2013/05/16/azithromycin-heart.html

Antibiotic Zithromax label to warn of potential heart side-effect

Health Canada says caution needed when treating patients with certain risk factors

The antibiotics Zithromax and Zmax SR (azithromycin) can cause potentially fatal irregular heart rhythms, Health Canada says.

Azithromycin is used for bronchitis, pneumonia, chest infections, urinary tract and other common infections.

Thursday's advisory from Health Canada says a "small absolute increase in the risk of cardiovascular deaths was observed in patients taking azithromycin as compared to those who took no antibiotics and those who took amoxicillin in a recent study."

In March, the U.S. Food and Drug Administration warned that the antibiotic, sold in Canada and the U.S. as Zithromax, can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.

[Article continues at original source]

Takeda Gets $6.5 Million Diabetes-Drug Verdict Thrown Out

Quoted from http://www.bloomberg.com/news/2013-05-01/takeda-gets-6-5-million-diabetes-drug-verdict-thrown-out.html

Takeda Gets $6.5 Million Diabetes-Drug Verdict Thrown Out

By Jef Feeley - May 1, 2013 5:12 PM ET

Takeda Pharmaceutical Co. persuaded a judge to throw out a $6.5 million jury verdict over its Actos diabetes drug because lawyers for a California man didn’t produce sufficient evidence to show his cancer was caused by the medication.

Judge Kenneth Freeman in state court in Los Angeles ruled today Jack Cooper’s attorneys weren’t able to properly link the former telephone-company worker’s bladder cancer to his Actos use and jurors shouldn’t have had a chance to return their verdict against Asia’s largest drugmaker. It was the first of more than 3,000 lawsuits over the medication to go to trial.

Testimony from a doctor who concluded Cooper’s Actos use caused his bladder cancer turned out to be “inherently unreliable” and that justified throwing the case out, Freedman said in a 27-page ruling.

[Article continues at original source]

Related articles

Takeda loses cancer suit over Actos

Takeda Denies Actos Bladder-Cancer Link at First Trial

Takeda's Actos Diabetes Drug Tied to Cancer, Jury Is Told

Cancer drug Avastin tied to 2 cases of flesh-eating disease in Canada

Quoted from http://www.cbc.ca/news/health/story/2013/05/02/avastin-flesh-eating-disease.html

Cancer drug Avastin tied to 2 cases of flesh-eating disease in Canada

Health Canada issues caution to users, echoing U.S. warning

CBC News

Posted: May 2, 2013 11:05 AM ET

The cancer-treatment drug Avastin has been linked to 52 cases of flesh-eating disease worldwide, including one that resulted in death in Canada.

Health Canada issued a warning today in conjunction with the drug's manufacturer, Hoffmann-La Roche Ltd., echoing an earlier one from the U.S. Food and Drug Administration. It offered no specific details on two Canadian cases.

Avastin is used either alone to treat a particular type of brain cancer (glioblastoma), or in combination with chemotherapy to treat cancers that have spread to other parts of the body such as colon, rectal and lung cancer.

[Article continues at original source]

Antibiotic Azithromycin Won't Harm Healthy Hearts: Study

Quoted from http://www.philly.com/philly/health/topics/HealthDay675895_20130501_Antibiotic_Azithromycin_Won_t_Harm_Healthy_Hearts__Study.html

Antibiotic Azithromycin Won't Harm Healthy Hearts: Study

Kathleen Doheny HealthDay Reporter

Posted: Wednesday, May 1, 2013, 5:00 PM

WEDNESDAY, May 1 (HealthDay News) -- The widely used antibiotic azithromycin (Zithromax or Zmax) -- under scrutiny recently because it may increase the risk of death for those with existing heart disease -- appears to be safe for young and middle-aged adults without heart problems, according to a large new study.

Danish researchers evaluated more than a million episodes of azithromycin use, comparing it to both the use of no antibiotics and to the use of penicillin V, from 1997 through 2010. Patients were aged 18 to 64.

"We believe that the results are reassuring," said Henrik Svanstrom, a researcher at Statens Serum Institute, in Copenhagen. His study is published in the May 2 issue of the New England Journal of Medicine.

[Article continues at original source]

Takeda loses cancer suit over Actos

Quoted from http://www.japantimes.co.jp/news/2013/04/29/national/takeda-loses-cancer-suit-over-actos-2/

Takeda loses cancer suit over Actos

Drugmaker told to pay dying U.S. man $6.5 million for slack risk warnings

Bloomberg

• Apr 29, 2013

LOS ANGELES – Takeda Pharmaceutical Co. owes $6.5 million in damages to a California man who said Asia’s largest drugmaker failed to warn consumers its Actos diabetes drug could cause cancer, a jury said in the first of more than 3,000 lawsuits over the medication to go to trial.

Jurors in state court in Los Angeles deliberated for more than five days before finding Osaka-based Takeda didn’t provide adequate bladder-cancer warnings to Jack Cooper and his doctors about Actos.

Cooper, 79, took the drug for more than four years before being diagnosed with the disease in 2011.

[Article continues at original source]

Related articles

Takeda Denies Actos Bladder-Cancer Link at First Trial

Takeda's Actos Diabetes Drug Tied to Cancer, Jury Is Told

Takeda Denies Actos Bladder-Cancer Link at First Trial

Quoted from http://www.businessweek.com/news/2013-04-16/takeda-denies-actos-bladder-cancer-link-at-first-trial

Takeda Denies Actos Bladder-Cancer Link at First Trial

By Valerie Reitman and Jef Feeley on April 16, 2013

Takeda Pharmaceutical Co., Asia’s biggest drugmaker, denied its Actos drug caused a California man’s bladder cancer in the first of more than 3,000 lawsuits over the diabetes medication to go to trial.

Plaintiff Jack Cooper developed bladder cancer, the fifth- most common form of cancer, as a result of factors other taking Actos, Sara Gourley, a Takeda lawyer, told a state court jury in Los Angeles today. Cooper, 79, is diabetic and a former smoker, she said.

“The evidence is not only clear, it is overwhelming, that Mr. Cooper is in the highest-risk groups, and that his bladder cancer had nothing to do with Actos,” Gourley said.

[Article continues at original source]

Related articles

Takeda's Actos Diabetes Drug Tied to Cancer, Jury Is Told

Takeda Didn't Warn of Actos Cancer Risk, Lawyer Says

Takeda Put Actos Sales Ahead of User Safety, Witness Says

Takeda’s Actos Diabetes Drug Tied to Cancer, Jury Is Told

Quoted from http://www.businessweek.com/news/2013-04-15/takedas-actos-diabetes-drug-tied-to-cancer-jury-is-told

Takeda’s Actos Diabetes Drug Tied to Cancer, Jury Is Told

By Valerie Reitman, Phil Milford and Jef Feeley on April 16, 2013

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, hid the cancer risks of its Actos drug to protect billions in sales, a jury was told in the first of more than 3,000 lawsuits over the diabetes medication to go to trial.

While Takeda’s internal Actos studies uncovered links to bladder cancer as early as 2004, the company didn’t alert U.S. regulators until seven years later, Michael Miller, a lawyer for plaintiff Jack Cooper, told a state court jury in Los Angeles yesterday. The company kept quiet to protect more than $1.6 billion in annual Actos sales, he added.

“Selling diabetes drugs is big business in America,” Miller said in closing arguments in the trial of Cooper’s suit against Takeda. “There’s a lot of money to be made. But companies are not allowed to downplay the risk. Patient safety is the No. 1 thing.”

[Article continues at original source]

Related articles

Takeda's Actos Diabetes Drug Tied to Cancer, Jury Is Told

Takeda Put Actos Sales Ahead of User Safety, Witness Says

Takeda Didn't Warn of Actos Cancer Risk, Lawyer Says

Eli Lilly and Co. settles wrongful death lawsuit

Quoted from http://www.indystar.com/article/20130409/BUSINESS/304090105/Eli-Lilly-Co-settles-wrongful-death-lawsuit

Eli Lilly and Co. settles wrongful death lawsuit

Apr 9, 2013

Eli Lilly and Co. has settled a long-running wrongful death lawsuit filed by the parents of a South Dakota boy who committed suicide on Christmas Eve 2004, four weeks after taking the antidepressant Cymbalta.

The settlement comes a month before a jury trial was set to begin in a South Dakota federal court.

Terms weren’t disclosed in court filings. An order filed last week by a magistrate judge said the settlement involved setting up a trust fund bearing the name of the 16-year-old boy, Peter Schilf. The order also refers to “payment by Lilly of the agreed confidential amount.”

[Article continues at original source]

EU medicines agency to restrict use of Otsuka drug

Quoted from http://news.yahoo.com/eu-medicines-agency-restrict-otsuka-drug-105637064--sector.html

EU medicines agency to restrict use of Otsuka drug

Reuters–Fri, Mar 22, 2013

LONDON (Reuters) - The European Medicines Agency said on Friday it was recommending restricting the use of medicines containing cilostazol, sold by Otsuka under the brand name Pletal, following concerns over side effects.

A review of evidence found the drug's modest benefit was only greater than its risk of damaging the heart or causing serious bleeding in a limited number of patients.

Cilostazol, also sold as Ekistol, is used for treatment of intermittent claudication, or limping, usually as a result of arterial disease.

[Article continues at original source]