Drug Safety Developments

US judge narrows benchmark Fosamax case vs. Merck

Quoted from http://www.reuters.com/article/2011/08/30/merck-fosamax-idUSN1E77T1IJ20110830

US judge narrows benchmark Fosamax case vs. Merck

By Jonathan Stempel

NEW YORK, Aug 30 (Reuters) - A federal judge on Tuesday threw out part of a bellwether lawsuit against Merck & Co (MRK.N) over claims that its osteoporosis drug Fosamax causes jaw damage.

The plaintiff, Linda Secrest, may pursue her claim that Fosamax suffered from a design defect and caused her jawbone tissue to die, a condition known as osteonecrosis of the jaw, or ONJ, U.S. District Judge John Keenan wrote.

But the judge said Secrest, a former United Airlines flight attendant living in Florida, cannot pursue punitive damages or her claim that Merck failed to warn of possible problems with Fosamax, saying no reasonable jury could rule in her favor.

The lawsuit is the fourth bellwether case over Fosamax, which generated billions of dollars in annual sales for Merck before the Whitehouse Station, New Jersey-based company lost U.S. patent protection in 2008, allowing generic sales.

Results of bellwether cases may foreshadow the potential outcomes of other, similar lawsuits.

 

Merck has said it faced roughly 1,650 Fosamax-related cases in various courts as of June 30, including 910 before Keenan.

It won two of the earlier bellwether trials, while a jury ordered it to pay $8 million to the plaintiff in the third case.

Keenan later reduced that payout to $1.5 million, prompting the plaintiff, Shirley Boles, to request a new trial on damages. Merck appealed a separate legal issue to the federal appeals court in New York.

[Article continues at original source]

Avastin Injections Are Said to Cause Blindness

Quoted from http://www.nytimes.com/2011/08/31/health/31drug.html

Avastin Injections Are Reported to Cause Blindness

By ANDREW POLLACK

Published: August 30, 2011

At least 16 people in two states have gotten severe eye infections, and some have been blinded, from injections of the drug Avastin, according to health authorities and to lawyers representing the patients.

The cancer drug Avastin has been used by some doctors to treat macular degeneration, an off-label application.

The incidents, in Florida and Tennessee, demonstrate the risks associated with the money-saving practice of injecting Avastin into the eye to treat the wet form of age-related macular degeneration, a common cause of severe vision loss in the elderly.

Avastin, sold by Genentech, is approved to treat cancer, not eye disease. But many retina specialists use Avastin off label because it costs only about $50 an injection, compared with $2,000 for Lucentis, another Genentech drug that has the same mode of action and is approved as an eye treatment.

The off-label use of Avastin has saved Medicare and patients hundreds of millions of dollars a year. But dividing a vial of Avastin into numerous tiny doses for injection into the eye introduces the risk of bacterial contamination. That is apparently what has happened in the cases in Florida and Tennessee.

The Food and Drug Administration issued an alert late Tuesday saying that at least 12 patients in Miami, treated at three clinics, had suffered eye inflammations. While all had impaired eyesight to begin with, some lost all remaining vision in the treated eye, the agency said.

[Article continues at original source]

Merck Wins Reversal of $32 Million Vioxx Jury Award in Texas Supreme Court

Quoted from http://www.bloomberg.com/news/2011-08-26/merck-wins-reversal-of-32-million-vioxx-jury-award-in-texas-supreme-court.html

Merck Wins Reversal of $32 Million Vioxx Jury Award in Texas Supreme Court

By Jef Feeley - Aug 26, 2011 4:14 PM ET

Merck & Co. doesn’t have to pay a $32 million jury award to the family of former user of the company’s Vioxx painkiller who died of a heart attack, the Texas Supreme Court ruled.

The court today said the family of Leonel Garza didn’t produce adequate evidence showing Vioxx caused the heart attack, meaning the 2006 verdict must be thrown out. Merck, the second biggest U.S. drugmaker, agreed in 2007 to pay $4.85 billion to settle thousands of injury claims over the drug.

Lawyers for the Garzas “did not present reliable evidence of general causation and therefore are not entitled to recover against Merck,” the state’s highest court concluded in an 18-page decision.

[Article continues at original source]

Drug Multaq risky for one kind of atrial fibrillation: Health Canada

Quoted from http://www.winnipegfreepress.com/arts-and-life/life/health/126799568.html

Drug Multaq risky for one kind of atrial fibrillation: Health Canada

By: The Canadian Press

Posted: 08/4/2011 5:05 PM

OTTAWA - Health Canada is advising doctors not to prescribe the drug Multaq to patients with a certain heart rhythm disorder after a large international study found the medication may increase their risk of serious cardiovascular events.

The PALLAS study of the Sanofi-made drug, known generically as dronedarone, was halted when preliminary data suggested that patients with permanent atrial fibrillation were at a higher risk of heart-related events and stroke compared to patients not given Multaq.

Multaq helps control the abnormal heart rate and rhythm of AF, but in Canada the drug is authorized only for patients with various forms of intermittent atrial fibrillation — not the permanent form.

The trial had been exploring the use of Multaq in patients over 65 with permanent atrial fibrillation, in addition to other forms of heart disease.

Health Canada said patients taking Multaq should not stop the drug without talking to their health-care provider.

Patients should also speak to their health professional if they have concerns or if they notice any unexpected or worsening symptoms while taking Multaq, such as increasing shortness of breath, swelling of feet or legs, trouble breathing while lying down or sleeping, and-or shortness of breath while moving around.