Drug Safety Developments

Merck Loses Dismissal Bid in Third Fosamax Case

Quoted from http://www.bloomberg.com/apps/news?pid=20601127&sid=a96.rJ9Ovgmg#

Merck Loses Dismissal Bid in Third Fosamax Case

By Thom Weidlich

Jan. 28 (Bloomberg) -- Merck & Co. lost its bid to dismiss the third case scheduled for trial over claims its osteoporosis drug Fosamax caused so-called jaw death.

The claim of the plaintiff, Louise Maley, “does not fail as a matter of law from a lack of evidence of exposed necrotic bone,” U.S. District Judge John Keenan in Manhattan wrote in a ruling entered into the case docket today. “Specific causation remains a material issue of fact for the jury.”

A trial is scheduled for April 19. Maley, of Muncie, Indiana, said she developed osteonecrosis of the jaw, or ONJ, by taking Fosamax, according to her complaint filed in May 2006.

On Nov. 23, Keenan, who’s overseeing the federal Fosamax litigation, ruled that Bessie Flemings, a Mississippi resident, couldn’t establish that the drug caused her ONJ and dismissed the case, which was set to be tried this month.

On Sept. 11, the judge declared a mistrial in the first Fosamax case to go to a jury over claims that Merck failed to warn doctors and patients that the drug might hamper blood flow to the jaw, causing jawbone-tissue death. The jury in that case couldn’t reach a unanimous verdict.

“The evidence will show that Fosamax did not cause Louise Maley to develop jaw-related problems as she claims and that Merck provided appropriate and timely information about Fosamax to the medical, scientific and regulatory communities,” Ronald Rogers, a company spokesman, said in an e-mailed statement today.

Keenan declined to grant Merck’s request for a so-called summary judgment on Maley’s claim that the drugmaker failed to warn about Fosamax’s dangers. She didn’t contest Merck’s dismissal request on her strict-liability and warranty claims, and the judge tossed those.

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Orange County trial will focus on Botox's safety in children's cerebral palsy treatments

Quoted from http://www.latimes.com/news/local/la-me-botox27-2010jan27,0,1928030.story

Orange County trial will focus on Botox's safety in children's cerebral palsy treatments

The family of Kristen Spears alleges an overdose of the drug manufactured by Irvine-based Allergan Inc. killed her at age 7. The firm has said the family cannot prove the allegations.

By Lisa Girion

January 27, 2010

Kristen Spears started getting Botox injections at the age of 6 -- not to smooth furrows in her brow, but to calm spasms in her legs.

The girl was born with severe cerebral palsy, and Botox, best known as a face-lift-in-a-syringe, can relax contorted muscles and sometimes help young patients walk without surgery.

Instead, Kristen's mother alleges, an overdose of the drug killed her.

Opening arguments in a negligence lawsuit by Dee Spears against Botox manufacturer Allergan Inc. are set for today in Orange County.

At issue is the safety of the blockbuster drug, especially in the higher dosages that are used to treat children with cerebral palsy.

It is believed to be the first Botox case alleging a fatal reaction to reach trial, and is one of several pending suits related to the drug's cosmetic and non-cosmetic uses.

The trial comes less than a year after federal authorities mandated "black box" labels that warn of potentially serious reactions to Botox. And it opens a window on the Irvine-based drug maker's own records of reported ill effects, showing that the company knew of some serious problems linked to neurotoxins such as Botox as early as 2005.

Allergan declined to comment on the trial. In a court motion, Allergan says that Kristen died of a bacterial infection and that her mother cannot prove Botox killed her.

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Monthly Updates Set for Biogen's Tysabri

Quoted from http://online.wsj.com/article/SB10001424052748703415804575023493628662602.html.html

Monthly Updates Set for MS Drug

By Thomas Gryta

JANUARY 25, 2010

Biogen Idec Inc. will communicate with doctors once a month on the occurrence of new cases of a rare brain infection in patients using its multiple sclerosis treatment Tysabri, as the biotech firm strives to find the right balance in keeping the medical and financial communities updated on that number.

The situation is closely watched because Tysabri, a treatment sold with Elan Corp., was previously pulled from the market because of its association with progressive multifocal leukoencephalopathy, or PML, a debilitating and often fatal condition. The infection rate has hurt the sales growth of the drug, which is key to Biogen's future and is Elan's biggest seller.

Since its re-emergence in 2008, Biogen and regulators have struggled with how to provide information on PML because case-by-case updates of a specific side effect are unprecedented. Last summer, the Cambridge, Mass., company stopped providing updates altogether.

As of mid-January, the number of cases stands at 31, which puts the overall incidence rate at about 1-in-1,000 patients, as implied by the drug's label.

Tysabri had more than $1 billion in 2009 sales, but its controversial history has provoked fear in investors and confusion about the disclosure of new cases hasn't helped.

Under the new plan, Biogen will update physicians midmonth and provide information through a password-protected Web site.

It will include the number of PML cases, with an incidence rate broken down by duration of use, as well as a cumulative patient exposure figure, which is different then the quarterly patient count provided to investors.

Investors can get the same information from investor relations, although the company won't be posting it on a public Web site or making an announcement.

Patient services will provide Tysabri users with information upon request, although not with the level of detail given to physicians, or even to investors.

The reason for the disparity between how doctors and patients are updated is because of regulations that restrict direct interactions between patients and drug companies, because those communications could be deemed as promotional activities and thus need to be cleared with regulators.

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Pfizer Move to Toss Menopause Video Rejected by Judge

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

Pfizer Move to Toss Menopause Video Rejected by Judge

By Sophia Pearson and Jef Feeley

Jan. 22 (Bloomberg) -- Pfizer Inc. can’t force plaintiffs’ attorneys to remove from the Internet a video about jury verdicts against the company related to its Prempro menopause medicine, a judge ruled, clarifying an earlier decision.

Plaintiffs’ attorneys who were ordered to remove the video from the Internet are now allowed to keep it up as long as they replace the title and indicate it is a plaintiffs’ presentation, state court Judge Sandra Moss in Philadelphia said in a Jan. 20 ruling.

“We are pleased the court ordered plaintiffs’ counsel to properly label their promotional video,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement. “Disguised as a news segment, the original video failed to inform viewers of its sponsorship by plaintiffs’ lawyers.”

The video, which has been viewed more than 7,000 times, was posted on Web sites including Google Inc.’s YouTube by plaintiffs’ attorneys who won more than $78 million in damages in a Pennsylvania trial over Pfizer’s hormone-replacement drugs.

Pfizer argued that the video, titled “Prempro News Segment,” violated state legal ethics rules and was aimed at swaying potential jurors in future trials over the drugs. The company sought to have it removed.

Moss, who is overseeing all cases involving Prempro in state court in Philadelphia, initially granted Pfizer’s request on Jan. 13. In clarifying her ruling, Moss ordered plaintiff attorneys to remove the title and indicate that it wasn’t a news segment.

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Heart Patients Warned Against Using Meridia, an Anti-Obesity Drug

Quoted from http://www.nytimes.com/2010/01/23/business/23diet.html

Heart Patients Warned Against Using Meridia, an Anti-Obesity Drug

By NATASHA SINGER and ANDREW POLLACK

Published: January 22, 2010

European and American drug regulators had two starkly different reactions this week to data on an obesity drug. The raw data from the study indicated that people with certain health problems who took the prescription diet drug Meridia had more heart attacks, strokes and other cardiovascular problems than people getting a placebo.

The F.D.A. urged a stronger warning label on the diet drug Meridia after a study showed complications in some users.

On Thursday, the European Medicines Agency advised doctors and pharmacists to stop prescribing and dispensing European equivalents of Meridia. The Food and Drug Administration, looking at the same study data on Thursday, took a less forceful step and asked Abbott Laboratories, the maker of Meridia, to put a stronger warning on its label.

The F.D.A. said the new warning should indicate that the drug was not to be used by people who have a history of heart attacks or strokes, or who have uncontrolled high blood pressure.

Abbott, which sells Meridia in Europe under various brand names, including Reductil and Ectiva, indicated Friday that it would comply with the F.D.A.’s labeling request and with the European advisory by suspending sales of the drugs in Europe.

Meridia contains the ingredient sibutramine, which works by increasing neurotransmitter activity in the brain, helping people to feel full after a meal and thereby reducing their food intake. The company said the drug was safe and effective when used in appropriate patients.

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FDA adds heart attack warning to Meridia diet pill

Quoted from http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2010/01/21/financial/f084034S80.DTL&type=health

FDA adds heart attack warning to Meridia diet pill

By MATTHEW PERRONE, AP Business Writer

Thursday, January 21, 2010

Abbott Laboratories on Thursday stopped marketing a weight loss pill in Europe after regulators there said the drug increases the risk of heart attack and stroke when used by heart disease patients.

The European Medicines Agency advised doctors and pharmacists to stop using sibutramine, saying "the risks of these medicines are greater than their benefits." The agency said Abbott's license to market the drug should be suspended, a recommendation European Union nations are expected to adopt.

"We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee's opinion and the recommendation to suspend the medicine," said Abbott spokesman Kurt Ebenhoch.

Meanwhile, the U.S. Food and Drug Administration added new warnings to sibutramine, marketed here as Meridia, highlighting its increased risks for patients with a history of heart problems. The new label says the drug should not be taken by patients with heart failure, hypertension, irregular heart beats and other problems.

In a statement posted online, the FDA urged patients to talk to their doctors about whether they should continue taking the drug.

"Health care professionals should regularly monitor the blood pressure and heart rate of patients using" Meridia, the FDA stated.

Abbott agreed to add the FDA's contraindication language to its marketing. The company, based in North Chicago, stressed that the drug is only approved for patients with no previous history of heart disease.

Consumer advocacy group Public Citizen petitioned the FDA to pull Meridia off the market late last year, based on new data about heart risks.

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Alli and Meridia Diet Drugs Warnings

Quoted from http://blogs.wsj.com/health/2010/01/21/meridia-another-diet-drug-warning/

Meridia: Another Diet-Drug Warning

By Jacob Goldstein

• January 21, 2010, 4:32 PM ET

It’s been a tough week for diet drugs. First, there were warnings that some people going to online auction sites to buy GlaxoSmithKline’s Alli weren’t getting the real thing. Instead, they were getting a counterfeit version that actually used the active ingredient from another diet drug — Abbott’s Meridia.

Today, it’s Meridia’s turn for trouble. European regulators said the drug — known generically as sibutramine, and sold in the EU under the brand names Reductil, Reduxade and Zelium — should be pulled from the market. In the U.S., the FDA said the drug shouldn’t be taken by patients with a history of heart disease — a significant limitation for a diet drug, given the link between heart disease and obesity.

At issue is a study that suggested the drug increased the risk of cardiovascular events (heart attack, stroke, that sort of thing) for people who already had heart trouble. Overall, 11.4% of the patients in the study who took the drug had cardiovascular events, compared with 10% who took a placebo. You can see how the subgroups break out in the table at the bottom of this page.

 

Abbott wasn’t immediately available for comment, Dow Jones Newswires said.

Biogen optimistic despite more PML cases

Quoted from http://boston.bizjournals.com/boston/stories/2010/01/18/daily32.html

 Biogen optimistic despite more PML cases

Boston Business Journal - by Julie M. Donnelly

Biogen Idec officials said Wednesday three more patients have contracted a rare brain infection associated with the company’s multiple sclerosis drug, Tysabri.

However, the Cambridge-based biotechnology company says the additional cases do not impact the overall safety profile for the medication.

The total number of cases of progressive multifocal leukoencephalopathy, or PML, since July 2008 now stands at 31.

More than 60,000 patients have taken Tysabri since the drug’s reintroduction in July 2006, and the incidence of PML is currently .47 cases per 1,000 patients. Tysabri’s warning labels said the anticipated incidence rate of PML is 1 in 1,000 rate.

The company took Tysabri off the market between February 2005 and July 2006 because of concerns about the risk of PML.

Since the risks of contracting PML increases the longer a patient takes the drug, the number of PML cases is expected to rise. So far, 19 cases have been detected in Europe, 10 cases in the United States. Two other cases have been detected elsewhere, according to Biogen officials.

Top obesity drug subutramine being withdrawn

Quoted from http://news.bbc.co.uk/2/hi/health/8473555.stm

Top obesity drug subutramine being withdrawn

Obesity levels are increasing   A leading obesity drug is being withdrawn from use in the UK amid fears it increases the risk of heart attacks and strokes. The Medicines and Healthcare Products Regulatory Agency has told doctors to stop prescribing subutramine and review its use in patients already taking it. The drug works by altering chemical messages to the brain which control feelings about food. The regulator says it has been used by 86,000 people in the past year. While it is a common obesity drug, the most popular, orlistat, a pill which prevents fat absorption, is much more widely used and is taken by hundreds of thousands of people each year. Suspending The regulator acted after a review by the European Medicines Agency recommended suspending its licence in Europe. This decision still has to be formally ratified by the European Commission. But Dr June Raine, of the MHRA, said: "Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweigh the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment. "Prescribers are advised not to issue any new prescriptions and to review the treatment of patients taking the drug. "Pharmacists are asked to cease dispensing the medicine. "People who are currently taking subutramine are advised to make a routine appointment with their doctor to discuss alternative measures to lose weight. There are no health implications if people wish to stop treatment before seeing their doctor."

Forest’s Drug Savella Should Be Recalled, Public Citizen Says

Quoted from http://www.bloomberg.com/apps/news?pid=20601103&sid=a0lZW4ldgHns

Forest’s Drug Savella Should Be Recalled, Public Citizen Says

By Alexandra Thomas

Jan. 20 (Bloomberg) -- Forest Laboratories Inc.’s Savella, used as a treatment for a painful nerve disorder that mainly strikes middle-age women, should be taken off the market because of increased heart risks, said the consumer advocacy group Public Citizen.

Study trials show Savella caused higher blood pressure and heart rate as well as thoughts of suicide in patients who had normal blood pressure before they started taking the pill, Washington-based Public Citizen said in a letter today to the U.S. Food and Drug Administration. Forest spokesman Frank Murdolo declined to comment in an e-mail. The company markets the drug with San Diego-based Cypress Bioscience Inc.

The FDA approved Savella, also known as milnacipran, as a treatment in January 2009 for fibromyalgia, a disorder characterized by a variety of pain-related symptoms including muscle pain and headaches. In July, European regulators rejected the drug, saying its benefits were marginal and didn’t outweigh the risks. Public Citizen said the drug is not effective in treating pain.

“The larger issue is this is a new kind of drug for fibromyalgia,” Sidney Wolfe, director of Public Citizen’s Health Research Group, said today in a telephone interview. “This is the first drug only approved just for fibromyalgia, and it shouldn’t have been. There are serious safety risks that outweigh the benefits, and the drug doesn’t work for pain alone.”

Savella generated sales of $15.4 million in the quarter ended Dec. 31, New York-based Forest said in a statement yesterday.

Spokesmen for Cypress Bioscience didn’t return a telephone call and e-mail seeking comment.