Drug Safety Developments

Biogen, Elan’s Drug Linked to 24 PML Cases, 4 Deaths

Quoted from http://www.bloomberg.com/apps/news?pid=20601202&sid=aCLgmEYb78tM

Biogen, Elan’s Drug Linked to 24 PML Cases, 4 Deaths

By Trista Kelley

Oct. 29 (Bloomberg) -- Biogen Idec Inc.’s multiple sclerosis drug Tysabri, jointly sold with Elan Corp., has been linked to four deaths by the European Medicines Agency.

The patients died of a deadly brain infection known as PML, and 24 cases of the disease have been diagnosed since Tysabri was reintroduced to the market in 2006, the European drug regulator said today in an e-mail. The U.S. Food and Drug Administration today confirmed the number of PML cases as 24 and declined to comment further. A call to Niamh Lyons, a spokeswoman for Dublin-based Elan, wasn’t immediately returned.

“We’re not commenting on individual cases of PML,” Jennifer Neiman, a Biogen spokeswoman, said today in a phone interview. “The incidence of PML is rare and the rate remains consistent with what was seen in clinical trials and what is described in our current label.”

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Bayer Faces Nearly 1,000 Trasylol Cases in Florida

Quoted from http://industry.bnet.com/pharma/10004977/bayer-faces-nearly-1000-trasylol-cases-in-florida/

Bayer Faces Nearly 1,000 Trasylol Cases in Florida

By Jim Edwards | Oct 26, 2009

Bayer faces almost 1,000 lawsuits in a Florida federal district court regarding its anti-bleeding drug Trasylol, according to the docket in the case (1:08-md-01928-DMM).

• Download the Trasylol docket here.

While there have been sporadic reports in local media of people filing claims against Bayer alleging Trasylol contributed to renal failure, there has been little overall publicity to what is clearly a massive multi-district litigation effort going on in Judge Donald Middlebrooks’ Southern District federal court.

The above docket shows 952 cases. Not all of those are Bayer Trasylol cases, but the vast majority are. In addition, as BNET has previously noted, cases are being filed in state courts all over the country. They all allege something similar: That a patient went in for surgery, was given Trasylol to prevent bleeding, and suffered renal failure or some other complication as a result.

An anonymous source tells BNET:

Bayer now has close to a 1,000 lawsuits related to Trasylol (consolidated into federal multi-district litigation (MDL) in Florida), plus an unknown but not insignificant number in state courts. Many of these are expected to be dismissed due to the expected difficulty with proving causation. The first trial is expected in March next year.

Bayer has denied that Trasylol is more risky.

On the federal court’s system’s PACER web site, some of the cases have already been dismissed. But Bayer is still in the process of replaying to may of the complaints.

The litigation is so massive that plaintiffs no longer have to write their own complaints. They can use a short-form complaint that is only four pages long. Plaintiffs simply check the boxes on it to allege their injuries.

New Tysabri Worries Emerge

Quoted from http://online.wsj.com/article/SB10001424052748703573604574491212194615886.html

Europe Takes Closer Look At Tysabri

By THOMAS GRYTA

A European panel has started a review of the controversial multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan PLC, citing a higher rate of a rare brain infection than previously disclosed.

The additional cases are important because they may increase the drug's risk profile and raise questions about the companies' responsibility in updating the market on the safety record of Tysabri, a product that generates nearly $1 billion in yearly revenue.

The European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, reported there have been 23 cases of progressive multifocal leukoencephalopathy, or PML, a number that the Food and Drug Administration later confirmed, adding that those cases were after Tysabri returned to the market in 2006. The FDA said it is continuing to assess the situation.

Previously, there had only been 13 confirmed cases of the infection since the drug re-entered the market in 2006, after being removed for 18 months because of a link to three other PML cases.

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Hefty Side Effect For Kids On Antipsychotics

Quoted from http://www.forbes.com/2009/10/27/antipsychotics-lilly-astrazeneca-business-healthcare-children.html

Hefty Side Effect For Kids On Antipsychotics

Robert Langreth, 10.27.09, 04:50 PM EDT

Study finds troubling weight gains in children taking brand-name psychiatric drugs.

A new study is likely to add to the furious debate over the rapid rise in the prescription of heavy-duty antipsychotic drugs to children. It found that kids' weight balloons by 10 to 19 pounds in just the first three months on the drugs, often leading to worrisome elevations of cholesterol, triglycerides and other metabolic parameters.

Weight gain is a known side effect of the drugs, but the new study is notable because it found far greater increases than had been seen in many previous trials. Researchers tracked 272 children between the ages of 4 and 19 who started taking various brand-name antipsychotic drugs for the first time between 2001 and 2007. They found weight gains varied by drug but appeared to be widespread across the entire class of medications, called atypical antipsychotic drugs.

"Weight gain was pervasive even in medications usually considered to be weight neutral in adults," says Albert Einstein College of Medicine psychiatrist Christoph Correll, who led the study, which was conducted at the Zucker Hillside Hospital in Queens, N.Y. "The worry is that weight gain sustained over long periods of time can cause adverse outcomes like diabetes and heart attacks and strokes."

Children who were prescribed Zyprexa from Eli Lilly packed on 19 pounds in three months after starting the drug. Seroquel from AstraZeneca, Risperdal from Johnson & Johnson and Abilify from Bristol-Myers Squibb were not that much better, causing kids to gain 10 to 13 pounds in the same period. Seroquel and Zyprexa caused statistically significant increases in cholesterol levels, while these two drugs and Risperdal increased levels of fatty particles in the blood called triglycerides. The findings are being published in the Journal of the American Medical Association.

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Matrixx says FDA unwilling to change stance on Zicam

Quoted from http://www.reuters.com/article/governmentFilingsNews/idUSBNG7944120091026

Matrixx says FDA unwilling to change stance on Zicam

Oct 26 (Reuters) - Matrixx Initiatives Inc said the U.S. health regulator has indicated that it is unwilling to reverse its position regarding the warning letter issued on company's nasal versions of Zicam cold remedy.

In June, the company voluntarily withdrew two of its existing Zicam products after the U.S. Food and Drug Administration issued a warning letter that the products could cause a loss of smell. [ID:nN24151638]

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Pfizer Unit’s Prempro Punitive Damages Verdict Remains Secret

Quoted from http://www.bloomberg.com/apps/news?pid=20601202&sid=ajS4lMTXVEnY

Pfizer Unit’s Prempro Punitive Damages Verdict Remains Secret

By Jef Feeley

Oct. 27 (Bloomberg) -- A Pfizer Inc. unit must pay an undisclosed amount of punitive damages to an Illinois woman who developed breast cancer after taking one of the drugmaker’s menopause treatments, a Philadelphia jury said yesterday.

Jurors deliberated 25 minutes before finding Pfizer’s Wyeth subsidiary was responsible for paying an award to Connie Barton. The specific amount of the award was sealed by the trial judge immediately after it was returned.

In September, the same jury awarded Barton $3.7 million in compensatory damages over the cancer linked to Wyeth’s Prempro hormone-replacement drug. Barton, 64, developed invasive breast cancer five years after she began taking the drug.

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Brain Disease Found in 3rd Patient on Roche’s Rituxan

Quoted from http://www.bloomberg.com/apps/news?pid=20601103&sid=a.soONQKbh5g

Brain Disease Found in 3rd Patient on Roche’s Rituxan

By Rob Waters

Oct. 23 (Bloomberg) -- A third arthritis patient taking Roche Holding AG and Biogen Idec Inc.’s Rituxan developed a rare and potentially fatal brain disorder, U.S. regulators said.

The 73-year-old patient, diagnosed three years ago with rheumatoid arthritis, was treated with Rituxan in February 2009, according to a letter to physicians from Biogen and Roche’s Genentech unit. She developed symptoms four to six months later and was diagnosed with the brain infection known as PML, or progressive multifocal leukoencephalopathy, according to a statement from the U.S. Food and Drug Administration.

The brain disease has been linked to the multiple sclerosis drug Tysabri marketed by Cambridge, Massachusetts-based Biogen and Irish drugmaker Elan Corp. The European Medicines Agency reported today on its Web site that the number of PML cases in Tysabri users has jumped to 23 from 13 disclosed earlier. Two fatal cases of PML have been reported in rheumatoid arthritis patients using Rituxan, which primarily treats blood cancers.

The woman was the first rheumatoid arthritis patient taking Rituxan to have contracted the brain illness who was not previously treated with a type of anti-inflammatory drug called a TNF antagonist. Basel, Switzerland-based Roche and Biogen co- market Rituxan in the U.S.

“The overall reporting incidence of PML in patients with rheumatoid arthritis receiving Rituxan is rare (3 reports in approximately 100,000 rheumatoid arthritis patients that have been exposed),” the companies said in the letter to doctors. “However, the information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.”

Pfizer Unit Must Pay Prempro Damages, Jury Concludes

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aMBoIgCxlUx0

Pfizer Unit Must Pay Prempro Damages, Jury Concludes

By Jef Feeley and Sophia Pearson

Oct. 23 (Bloomberg) -- A Pfizer Inc. unit concealed the breast-cancer risks of its hormone-replacement therapy drug Prempro and is liable for $3.7 million in damages to an Illinois woman, a Philadelphia jury ruled in the second phase of a trial.

Connie Barton, 64, developed invasive breast cancer five years after she began taking Prempro, made by Pfizer’s Wyeth unit. The same jury ruled Sept. 25 that the menopause drug caused her cancer and awarded her $3.7 million in compensatory damages. After deliberating for 45 minutes, jurors ruled today that Wyeth was at fault and is liable for the compensatory damages.

“The jury will return” next week to consider a punitive damage award against Wyeth, Philadelphia Common Pleas Judge Norman Ackerman said after the verdict today. Jurors will begin deliberating on the issue Oct. 26.

More than 6 million women have taken hormone-replacement medicines to treat menopause symptoms such as hot flashes, night sweats and mood swings. Until 1995, many patients combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera, made by Upjohn, another Pfizer unit.

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After son's suicide, campaign by Queensbury pair leads to warning label on Singulair

Quoted from http://www.timesunion.com/AspStories/story.asp?storyID=855222

After son's suicide, campaign by Queensbury pair leads to warning label on Singulair

By JENNIFER A. DLOUHY, Washington bureau First published in print: Wednesday, October 21, 2009

WASHINGTON -- A Warren County couple's campaign to warn the public about the potential psychological side effects of a popular asthma and allergy medicine reached a milestone with drug maker Merck & Co. recently agreeing to add a warning about "neuropsychiatric events" to prescribing information for Singulair. The two-paragraph notice that agitation, anxiety, hallucinations, suicide and other neuropsychiatric behaviors "have been reported in . . . patients taking Singulair" now will be included in a 19-page document generally consulted by doctors and pharmacists who prescribe and dispense the drug. The change, which was formally announced by the FDA in August, dovetails with separate information for patients noting that users of the medicine have reported "behavior and mood-related changes." The move was applauded by Kate and Dave Miller of Queensbury, who have lobbied the FDA and Merck to examine and spread awareness of the possible psychological side effects of the drug since 2007, when their 15-year-old son, Cody, committed suicide after using the medicine for 17 days to treat seasonal allergies. [Article continues at original source]

Missoula woman awarded $3.2M in lawsuit against maker of bone-strengthening drug Zometa

Quoted from http://www.missoulian.com/news/local/article_5925bf88-be6d-11de-bc95-001cc4c03286.html

Missoula woman awarded $3.2M in lawsuit against maker of bone-strengthening drug Zometa

By TRISTAN SCOTT of the Missoulian | Posted: Wednesday, October 21, 2009 11:05 pm

Jurors slapped a Swiss pharmaceutical company with a $3.2 million verdict Wednesday, wrapping up a Missoula woman's lawsuit that will have bearing on hundreds of cases against the company nationwide.

The jury of six men and six women received the case Tuesday afternoon and deliberated for six hours before retiring for the evening. The panel reconvened Wednesday morning and reached a verdict after less than two hours.

The case, tried over five days, involves claims by Peggy L. Stevens, 57, of Missoula. She filed suit against Novartis Pharmaceuticals Corp. last year, alleging the company was professionally negligent when it failed to disclose health risks associated with one of its medications, a bone-strengthening drug called Zometa.

Stevens has lymphoma and developed serious dental and jaw-related problems after taking the drug for several years. Her attorneys say the company knew patients taking Zometa were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures, like a tooth extraction.

Doctors in Missoula administered the drug to Stevens intravenously for three years before she had a tooth pulled in 2007 and developed the disease. Its symptoms include pain, loosening of teeth, exposed bone and infection.

On a national level, Novartis faces lawsuits from approximately 550 plaintiffs whose cases have been consolidated in a Tennessee federal court and a New Jersey state court. The first of those cases is slated for trial in March 2010 in New Jersey.

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