Drug Safety Developments

Novartis Downplayed Risk of Bone Drugs on Cancer Patients, Lawyer Says

Quoted from http://www.bloomberg.com/news/2010-11-01/novartis-officials-hid-risks-of-bone-drugs-aredia-and-zometa-lawyer-says.html

Novartis Downplayed Risk of Bone Drugs on Cancer Patients, Lawyer Says

By Jef Feeley and Jerry Adams - Nov 1, 2010 7:39 PM ET

Novartis AG officials downplayed risks that the drugmaker’s bone-strengthening medicines Aredia and Zometa could destroy patients’ jaws, a lawyer for a woman suing the company told a North Carolina jury.

Officials of the Basel, Switzerland-based drug company got reports from doctors as early as 2002 that Rita Fussman and other cancer patients taking Aredia and Zometa to prevent bone loss during treatment suffered irreplaceable jawbone damage, Bob Germany, a lawyer for Fussman’s family, said in opening statements in a trial over the medicines. Fussman died in 2009 of complications from breast cancer.

Fussman’s family contends Novartis didn’t adequately warn that Aredia and Zometa could cause disfiguring jaw damage that forced cancer patients such as Fussman to subsist on baby food, Germany told jurors in federal court in Winston-Salem.

Patients and their doctors “were not told the whole story about these drugs,” Germany said. “In fact, we were not told half the story.”

The Fussman family’s lawsuit is the third product-liability case to go to trial over the bone-strengthening treatments, which had 2009 sales of $1.5 billion, according to Novartis’s annual report. Both drugs are still on the market.

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Mother of the late Michelle Pfleger asserts contraceptive contributed to her daughter's death

Quoted from http://www.lehighvalleylive.com/warren-county/index.ssf?/base/news-3/1288497956223520.xml&coll=3

Mother of the late Michelle Pfleger asserts contraceptive contributed to her daughter's death

 Sunday, October 31, 2010 By TOM QUIGLEY and kurt bresswein

The Express-Times

INDEPENDENCE TWP. | Township resident Joan Cummins claims the cause of her daughter's sudden death is not as simple as an obstructed blood vessel.

She believes the use of the oral contraceptive Yaz contributed to the death of her daughter, 18-year-old Michelle A. Pfleger, and plans to sue the drug's manufacturer, Bayer HealthCare Pharmaceuticals Inc.

"She was on Yaz birth control for acne," Cummins said. "All you have to do is Google that and look at all the lawsuits."

The freshman teen at Elon University collapsed Sept. 24 as she walked to a morning class. She was pronounced dead a short time later at a nearby hospital. The North Carolina Office of the Chief Medical Examiner attributed her death to a pulmonary thromboemboli, or obstruction of a blood vessel in the lung.

Bayer in April, in agreement with the U.S. Food and Drug Administration, updated its labels for Yaz and Yasmin to warn of "the relative risk of developing venous thrombosis," or blockage in a vein.

The day before Pfleger died, a physician treated her with an analgesic for a knee problem, according to the autopsy report.

"There's just really no reason that a healthy young woman who had a knee injury would have developed this," Cummons said of the fatal obstruction.

The North Carolina medical examiner takes note of the knee injury but does not link it to Pfleger's death. The report never mentions Yaz.

Joan Cummins said her daughter was healthy.

"She was 18 years old, completely healthy, at college, with the world at her fingertips," Cummins said.

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Osteoporosis drugs and broken bones

Quoted from http://www.sbsun.com/living/ci_16451707

Osteoporosis drugs and broken bones

Joe Graedon and Teresa Graedon Posted: 10/27/2010 07:17:55 PM PDT

Popular osteoporosis drugs are coming under scrutiny. Bisphosphonate drugs such as Actonel, Boniva, Fosamax and Reclast are supposed to build strong bones and prevent fractures.

But an odd thing has happened. During the past few years, evidence has been building that these drugs may increase the risk of an unusual type of fracture (Journal of the American Medical Association, Oct. 6, 2010).

The Food and Drug Administration has just issued a safety announcement warning about "atypical fractures of the thigh." These femur fractures can occur without a fall, collision or trauma. Just walking may bring on this uncommon break.

Readers of this column have been reporting this kind of broken bone for some time: "I had been on Fosamax for seven years when I started having leg pain. The doctors I saw could not find anything wrong. Then one morning in the steam room at the gym, my left femur just snapped in half. It was a weird break, and I had to have a rod put in.

"Less than six months later, I was rushing around my son's kitchen getting my grandkids' breakfast and my right femur broke, making me fall. It broke in the same place as the left, and now I have rods in both legs."

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Firm with Earth City unit is settling suits over drugs tied to suicides

Quoted from http://www.stltoday.com/business/article_c569f2c4-58a7-5432-a939-ff22e90583e5.html

Firm with Earth City unit is settling suits over drugs tied to suicides

BY JIM DOYLE

Posted: Saturday, October 30, 2010 12:05 am

ST. LOUIS • A month after its Earth City subsidiary pleaded guilty of illegally marketing antidepressants to children and adolescents, Forest Laboratories is now settling a string of wrongful death and personal injury lawsuits from the parents of children who took the drugs Celexa and Lexapro.

Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug's clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro.

Four of the cases were settled Friday, and two additional cases were settled in recent weeks.

A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.

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