Drug Safety Developments

Anemia Drugs Hold Dangers for Kidney Patients

Quoted from http://health.usnews.com/health-news/family-health/digestive-disorders/articles/2010/05/05/anemia-drugs-hold-dangers-for-kidney-patients.html

Anemia Drugs Hold Dangers for Kidney Patients

Study finds increased risks for potential deadly complications

By Ed Edelson
HealthDay Reporter

WEDNESDAY, May 5 (HealthDay News) -- The powerful drugs used to fight anemia caused by kidney failure increase the risk for cardiovascular problems such as heart attack, a major study has found.

A meta-analysis of 27 trials, which included more than 10,000 people who were given the drugs, known as erythropoiesis-stimulating agents (ESAs), found that those who took the drugs at the highest dosages had a 51 percent increased risk for stroke and a 33 percent increased risk for thrombosis, or blockage of an artery. The study, by an international group of experts, was published online May 3 in Annals of Internal Medicine.

The increased risk for death (9 percent) and serious cardiovascular events such as heart attacks (15 percent) did not reach statistical significance, the analysis found.

The U.S. Food and Drug Administration has acted to control the use of ESAs marketed as Epogen, Procrit and Aranesp, which stimulate production of red blood cells to treat the anemia caused by kidney failure and cancer chemotherapy. The agency has added a "black box" warning of dangers to ESA labeling.

The new study adds emphasis to such moves, said Dr. Ajay K. Singh, an associate professor of medicine at Harvard Medical School and a nephrologist at Brigham and Women's Hospital in Boston.

"This meta-analysis shows increased risk with no benefit," Singh said. "The supposed benefit is that ESAs improve quality of life and make people feel better. This study suggests that these drugs, used at considerable cost, don't show any benefit in terms of those endpoints."

[Article continues at original source]

Merck wins federal Fosamax trial

Quoted from http://www.reuters.com/article/idUSN0511162620100505

Merck wins federal Fosamax trial

Wed May 5, 2010 6:26pm EDT

NEW YORK, May 5 (Reuters) - A federal jury in New York on Wednesday found that a woman who claimed she was harmed by Merck & Co's (MRK.N) osteoporosis drug Fosamax did not suffer from a serious jaw condition linked to the medicine, handing Merck a victory, the drugmaker said.

The plaintiff, Louise Maley, an Indiana woman who used Fosamax for nearly eight years, claimed that she suffered osteonecrosis of the jaw -- a form of bone death associated with Fosamax and similar drugs -- and dental problems as a result of long-term use of the medicine.

The New York jury deliberated for only about half an hour before returning unanimous verdict in Merck's favor by finding that the plaintiff did not suffer from osteonecrosis of the jaw as of March 31 2004.

Had the jury ruled in Maley's favor on that first question it would then have taken up whether Fosamax caused the condition and whether Merck acted properly in its marketing of the product.

"Unfortunately, the plaintiff had multiple medical conditions that cause people to develop the jaw and dental problems she claims she has, regardless of whether they were taking Fosamax," Merck attorney Christy Jones said in a statement.

As of Dec. 31, about 978 Fosamax cases, which include some 1,356 plaintiff groups, were pending against the company in either federal or state court, Merck said.

U.S. District Judge John Keenan, who is handling many of the Fosamax personal injury cases, in January refused a Merck motion to dismiss the Maley case, calling it one of the "bellwether" trials in nationwide litigation over the osteoporosis drug.

A previous Fosamax trial involving a different plaintiff resulted in a mistrial after an eight-person jury could not reach a unanimous verdict. That case is set to be retried next month, Merck said.

Fosamax is part of the bisphosphonate family of osteoporosis drugs that include Actonel, sold by Warner Chilcott (WCRX.O), and Roche Holding AG's (ROG.VX) Boniva.

The drugs are designed to prevent bone fractures and help offset bone loss associated with menopause.

Fosamax once generated about $3 billion in annual sales for Merck, but they have plunged since cheaper generic versions of the medicine became available in 2008.

Wyeth Seeks New Trial in Nevada Prempro Case

Quoted from http://www.law.com/jsp/article.jsp?id=1202457652653

Wyeth Seeks New Trial in Nevada Prempro Case

Sandra Chereb

The Associated Press

May 05, 2010

Wyeth Pharmaceuticals Inc. asked the Nevada Supreme Court for a new trial over its hormone replacement drugs, arguing Monday that a Reno jury wasn't properly instructed on punitive damages before awarding three women a multimillion dollar judgment on claims the drugs caused their breast cancer.

Lane Heard, a Washington, D.C., lawyer representing the Madison, N.J.-based pharmaceutical giant that has since been acquired by Pfizer Inc., said the jury's "premature" deliberation of punitive damages and comments about Wyeth executives' salaries made by the women's attorneys prejudiced jurors against the company.

Jurors in 2007 initially awarded Jeraldine Scofield of Fallon, Arlene Rowatt of Incline Village and Pamela Forrester of Yerington a combined $134.5 million. But after a bailiff overheard a discussion and jury confusion became apparent, Washoe District Judge Robert Perry ordered them to reconsider.

They slashed $100 million from the compensatory judgment, awarding a combined $35 million to the women for past and future medical expenses, pain and suffering. Following a separate hearing, they then imposed $99 million in punitive damages intended to punish the company.

 

Forrester died eight months later.

Once the jury deliberated without being instructed, "it was not a fair and impartial jury," Heard said, arguing that after the judge determined jurors prematurely awarded punitive damages, a new trial, with new jurors, should have been ordered.

Perry later reduced the overall judgment to $58 million -- still the largest personal injury award in Nevada history -- ruling that the original award was excessive.

[Article continues at original source]

Albuquerque woman alleges human papillomavirus vaccine Gardasil injured teenage daughter

Quoted from http://www.startribune.com/business/92679104.html

Albuquerque woman alleges human papillomavirus vaccine Gardasil injured teenage daughter

Associated Press

Last update: May 3, 2010 - 4:16 PM

ALBUQUERQUE, N.M. - An Albuquerque woman has filed a lawsuit over a vaccine intended to protect women from cervical cancer, alleging it caused physical and behavioral problems in her teenage daughter.

The lawsuit filed by Tracy Wolf said her now-16-year-old daughter was diagnosed with a seizure disorder, encephalitis and other health problems after receiving Gardasil's three-shot series in 2007 and 2008, the Albuquerque Journal reported in a copyright story Monday.

Wolf observed physical problems such as heart palpitations and "significant, negative changes" in her daughter's behavior about a month after the first injection, according to the lawsuit, which said the teen had been diagnosed with type-1 diabetes and mild cerebral palsy before receiving Gardasil.

The lawsuit was filed April 14 in the U.S. Court of Federal Claims in Washington, D.C., against the secretary of Health and Human Services....

[Article continues at original source]

FDA probes risks of HIV, prostate, other drugs

Quoted from http://www.reuters.com/article/idUSTRE6424DA20100503

FDA probes risks of HIV, prostate, other drugs

Mon May 3, 2010 2:50pm EDT

WASHINGTON (Reuters) - Regulators are investigating potential risks from Abbott Laboratories Inc's HIV drug Kaletra, GlaxoSmithKline Plc's prostate drug Avodart and other medicines.

The Food and Drug Administration said on Monday it was probing reports of liver toxicity with patients who used Kaletra to prevent HIV infection after exposure to the AIDS virus.

The agency also said it was investigating cases of male breast cancer in patients treated with Avodart as well as Merck & Co's prostate drug Proscar and baldness treatment Propecia.

The FDA releases a quarterly list of safety probes to inform the public about early investigations of potential side effects that have been reported. The list released on Monday covered issues identified between October and December 2009.

Being on the list does not mean the FDA has concluded the drug causes the specific risk, the agency said.

The FDA posted the list here