Drug Safety Developments

Scottsdale-based maker of Zicam faces lawsuit

Quoted from http://www.azcentral.com/news/articles/2009/06/22/20090622biz-zicam0623-CP.html

Scottsdale-based maker of Zicam faces lawsuit

by Ken Alltucker - Jun. 22, 2009 04:54 PM

The Arizona Republic

In what could be the opening salvo in a new wave of lawsuits against the Scottsdale-based maker of Zicam, lawyers on Monday filed a lawsuit on behalf of 117 people who claim they have suffered loss of smell after using the popular nasal spray.

Among those suing Scottsdale-based Matrixx Initiatives Inc. include one dozen Phoenix-area residents as well as the chef of an upscale Las Vegas-area restaurant who no longer can smell or taste food.

Matrixx officials said Monday they had not seen the lawsuit filed in Maricopa County Superior Court, but a spokesman said the company believes that its nasal products are safe and do not cause loss of smell.

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Hydroxycut weight-loss products sued

Quoted from http://www.contracostatimes.com/california/ci_12618324

    Hydroxycut weight-loss products sued

From wire service reports Posted:06/18/2009 07:00:58 AM PDT

A class action lawsuit filed Wednesday in Los Angeles accuses recalled Hydroxycut weight-loss products of causing deadly liver damage and other severe complications.

The suit, filed in U.S. District Court on behalf of anyone who consumed the now-banned supplements, claims the company failed to warn users of the risks of injury.

The Hydroxycut products were recalled May 1 after being linked to dozens of cases of liver damage, jaundice, and other related injuries. In one case, a 19-year-old Hydroxycut user died in 2007 after developing liver failure, but the death was not reported to the Food and Drug Administration until last March, according to the complaint.

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US FDA staff urge review of Abbott drug risks

Quoted from http://www.reuters.com/article/marketsNews/idINN1943894220090619?rpc=44

US FDA staff urge review of Abbott drug risks

Fri Jun 19, 2009 11:21am EDT

By Lisa Richwine

WASHINGTON, June 19 (Reuters) - U.S. drug reviewers have recommended additional study of delayed development reported in children of mothers who took Abbott Laboratories' (ABT.N) anti-seizure drug Depakote.

Six cases received since its approval in 1983, including two siblings reported to have autism, "raise concerns," Food and Drug Administration staff wrote in a May 6 memo released on Friday.

Limitations in the reports "make it impossible to definitively conclude" the drug played a role, and genetics or other factors may have contributed, especially in the two sibling cases of autism, the FDA reviewers said.

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Biogen Reports Ninth PML Case In Tysabri MS Patient

Quoted from http://online.wsj.com/article/BT-CO-20090619-713247.html

Biogen Reports Ninth PML Case In Tysabri MS Patient

By Thomas Gryta

Of DOW JONES NEWSWIRES

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) reported that a ninth patient on its multiple sclerosis drug Tysabri, sold with Elan PLC (ELN), has developed a rare brain infection, the third such report since mid-May.

A suspected link to progressive multifocal leukoencephalopathy, or PML, led to Tysabri being pulled from the market for 18 months beginning in 2005. Prior to Friday, the company has reported that eight people had confirmed cases of PML, with one dying, since the relaunch. The most recent case was reported one week ago. ...

The drug was allowed back on the market in 2006 because of its effectiveness in fighting the degenerative disease and the incidence of PML remains well below the long-projected risk of one in 1,000 patients developing the infection.

 

"PML is still very rare in Tysabri-treated patients," said Biogen spokeswoman Shannon Altimari.

The patient with the latest confirmed PML case took 34 doses of the monthly medication and was located overseas. Only two of the nine cases since last July were located in the U.S.

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FDA warning stuns Scottsdale company Matrixx

Quoted from http://www.azcentral.com/arizonarepublic/business/articles/2009/06/19/20090619biz-zicam0619.html

FDA warning stuns Scottsdale company Matrixx

Report said Zicam swabs, gels can cause loss of smell

by Ken Alltucker - Jun. 19, 2009 12:00 AM

The Arizona Republic

The Scottsdale company that makes and sells Zicam said the Food and Drug Administration's safety warning about the popular nasal gels and swabs came as a complete surprise as the firm mounts an aggressive defense of its products' safety.

Matrixx Initiatives Inc. executives said they want to meet with the FDA to dispute the federal agency's warning issued this week that the Zicam gel and swabs can permanently damage the sense of smell.

"We are hopeful that if we can tell our story to the FDA, we can get them to change their mind," William Hemelt, acting president and chief operating officer of Matrixx, said during a Thursday morning conference call with analysts. "We are certainly hoping for that outcome, but we are moving ahead as if that may not happen."

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AstraZeneca Can’t Stop Testimony by Seroquel Expert Witness

Quoted from http://www.bloomberg.com/apps/news?pid=20601085&sid=a8tMS8AIfZZM

AstraZeneca Can’t Stop Testimony by Seroquel Expert Witness

By Margaret Cronin Fisk and Jef Feeley

June 19 (Bloomberg) -- AstraZeneca Plc can’t block testimony by a medical expert that its antipsychotic Seroquel can cause weight gain and diabetes, a federal judge ruled.

The witness, Donna Arnett, professor and chairwoman of the epidemiology department at the University of Alabama at Birmingham, contends that Seroquel causes metabolic changes, which can lead to diabetes without weight gain. She also contends metabolic risks occur with Seroquel throughout treatment, according to court papers.

AstraZeneca, based in London, sought to have Arnett disqualified, saying she cherry-picked data favorable to her opinion. U.S. District Judge Anne C. Conway said yesterday that Arnett will be allowed to testify in Seroquel trials, with a jury deciding whether her conclusions are credible.

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Matrixx Said It Didn’t Give 800 Zicam Reports FDA

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aDC21YXDGWvY

Matrixx Said It Didn’t Give 800 Zicam Reports to FDA

By Shannon Pettypiece

June 18 (Bloomberg) -- Matrixx Initiatives Inc. said today it didn’t turn over to U.S. regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs.

 

Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning “a surprise,” during a conference call with analysts. ...

 

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

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Homeopathy and potential hazards

Quoted from http://www.denverpost.com/business/ci_12615248

Homeopathy and potential hazards

Zicam suits spur re-examination

By Jeff Donn

The Associated Press   Posted:06/18/2009

CAMBRIDGE, Mass. — The unsettling little secret of Zicam Cold Remedy finally spilled out this week. Though widely sold for years as a drug for colds, it was never tested by federal regulators for safety like other drugs. And that was perfectly legal — until scores of consumers lost their sense of smell.

One little word on Zicam's label explains all this: "homeopathic." Zicam and hundreds of other homeopathic remedies — highly diluted drugs made from natural ingredients — are legally sold as treatments with explicit claims of medical benefit. Yet they don't require federal checks for safety, effectiveness or even the right ingredients.

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Seroquel Litigation a Bust? Not So Fast, Says Plaintiffs' Lawyer

Quoted from http://www.law.com/jsp/tal/digestTAL.jsp?id=1202431516575

Seroquel Litigation a Bust? Not So Fast, Says Plaintiffs' Lawyer

By David Bario

June 16, 2009

It's not exactly rare for the Litigation Daily to hear that the opposing side disagrees with how we characterize a victory in a high-stakes case. But after our Monday story asked whether Seroquel was shaping up to be the mass tort that wasn't, we got an intriguing earful from one of the leading Seroquel plaintiffs' lawyers.

In an e-mail Tuesday, Weitz & Luxenberg partner Paul Pennock wrote that, "far from going away, Seroquel is about to reveal AstraZeneca as one of the worst managers of a mass tort litigation in history." In a follow-up phone call, Pennock told us why he thought we'd missed the big picture.

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FDA: over-the-counter cold spray Zicam has caused loss of smell in more than 100 patients

Quoted from http://www.startribune.com/lifestyle/health/48157892.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aULPQL7PQLanchO7DiUsX

FDA: over-the-counter cold spray Zicam has caused loss of smell in more than 100 patients

The Food and Drug Administration says consumers should stop using Zicam Cold Remedy nasal gel and related products immediately.

By MATTHEW PERRONE, Associated Press

Last update: June 16, 2009 - 2:28 PM

WASHINGTON - Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives' Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

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