TheStar.com | GTA | Heart drug's higher death risk detailed in study

TheStar.com | GTA | Heart drug's higher death risk detailed in study: "A massive Canadian study that caused a popular heart surgery drug to be pulled from the shelves last November has shown it increased the risk of death by 50 per cent over two rival medications." [thestar.com]

Nova Scotia News - TheChronicleHerald.ca

Nova Scotia News - TheChronicleHerald.ca: "An expensive drug used to minimize severe bleeding during heart surgery actually significantly increased the risk that patients would die during surgery or in the 30 days following, a Canadian study comparing the drug to two far cheaper alternatives shows." [The Canadian Press]

AFP: Drug aprotinin boosts risk of death: study

AFP: Drug aprotinin boosts risk of death: study: "Aprotinin, a drug often used to prevent blood loss during heart surgery, boosts the risk of death by 50 percent, a major clinical study done in Canada and published in the United States Wednesday found confirming preliminary data." [AFP]

Trigger in Heparin Deaths Identified - Medgadget - www.medgadget.com

Trigger in Heparin Deaths Identified - Medgadget - www.medgadget.com: "An international group of investigators identified oversulphated chondroitin sulphate, a contaminant found in vials of heparin from China linked to a recent series of deaths, as a triggering agent." [megGadget]

FDA thinks it has trigger in heparin deaths - CNN.com

FDA thinks it has trigger in heparin deaths - CNN.com: "The Food and Drug Administration has 'now established a mechanism by which we think this contaminant could cause these adverse events,' said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research." [CNN]

Avandia Woes Mean Cutbacks at GlaxoSmithKline

Avandia Woes Mean Cutbacks at GlaxoSmithKline: "Avandia problems continue to hurt GlaxoSmithKline’s bottom line, as the Avandia maker announced this week that it would be giving up more than a $1 million in incentives so that it could eliminate jobs at its Zebulon, NC manufacturing plant. Avandia sales have dropped more than $1 billion worldwide since the controversial diabetes drug was linked to cardiac problems last may. The possible job cuts at the Zebulon plant are part of Glaxo’s plan to stem the bleeding caused by the Avandia debacle, as well as regulatory delays of some drugs awaiting approval and growing generic competition for some its other best selling medications." [NewsInferno]

First Avandia Lawsuits Filed, Many More Expected

First Avandia Lawsuits Filed, Many More Expected: "Avandia lawsuits against GlaxoSmithKline over the drug’s alleged cardiac side effects are beginning to make their way through the courts, and many more are expected. One a man is suing GlaxoSmithKline in federal court, claiming Avandia caused him to undergo heart bypass surgery. Attorneys allege the drug maker should have known that Avandia—prescribed to improve blood sugar in type 2 diabetes patients—is linked to a significant and increased risk of heart failure, heart attack, and stroke." [NewsInferno]

Actavis Recalls More Fentanyl Pain Patches

Actavis Recalls More Fentanyl Pain Patches: "More Fentanyl Pain Patches have been recalled by Actavis Inc due to a possible defect that could cause fentanyl to leak from the Actavis pain patches. Actavis had recalled 14 lots of the Fentanyl Pain Patches in mid-February. Actavis said the remaining lots of the fentanyl transdermal system patches are being recalled as a precautionary measure because the company lacks insurance that all patches are free from defects" [NewsInferno]

Medical News: Still More Fentanyl Pain Patches Recalled - in Product Alert, Prescriptions from MedPage Today

Medical News: Still More Fentanyl Pain Patches Recalled - in Product Alert, Prescriptions from MedPage Today: "Actavis, a maker of fentanyl patches, has expanded a recall to include all of its fentanyl pain patches sold in the United States, the company announced.

All of the recalled patches were manufactured by Corium International, a contractor for Actavis, and sold nationwide." [MedPageToday]

Fentanyl Patches With Reservoir Design Recalled

Fentanyl Patches With Reservoir Design Recalled: "Two drugmakers recently recalled their fentanyl transdermal patches due to concerns that the pain medicine contained in the patch could leak into the packaging, potentially causing serious adverse events such as fatal overdose and respiratory depression.

The patches subject to the recall use a reservoir design — a rectangular transparent unit with four functional layers and a drug-containing reservoir of fentanyl and alcohol USP." [FDA News]

14 WFIE, The Tri-State's News Leader: Top Drugs' Strange Side Effects

Top Drugs' Strange Side Effects: "n recent months, popular new anti-smoking treatment Chantix has made headlines for its array of potential side effects, which include insomnia and nightmares. In February, the U.S. Food and Drug Administration announced that Pfizer (nyse: PFE), the manufacturer of Chantix, had updated the drug's prescribing information to include additional warnings about the possibility of severe changes in mood and behavior in patients taking it." [14News]

Dividend Tempts, But Fog Cloaks Pfizer's Outlook

Dividend Tempts, But Fog Cloaks Pfizer's Outlook: "Sales of its smoking-cessation drug Chantix grew 773% in 2007. But that carries a qualifier. On Feb. 1, the FDA issued an advisory on Chantix, claiming that it had been linked to severe mood changes." [CNN]

eCanadaNow.com - Heparin Manufacturers Face Scrutiny

eCanadaNow.com - Heparin Manufacturers Face Scrutiny: "The factories that produce Heparin in the South China area are under intense focus as the United States struggles to ensure that the Heparin supply is safe. Workers clad in protective blue suits and surgical masks work to produce the drug, which is widely used world wide for blood thinning." [eCanadaNOW]

Japan: Heparin Recalled as Precaution - New York Times

Japan: Heparin Recalled as Precaution - New York Times: "Three Japanese companies have recalled heparin products made with raw materials from China that were processed by Scientific Protein Laboratories, according to a statement by the Wisconsin-based lab. “The three Japanese companies made clear that the recall was simply a precaution, as there has not been a pattern of adverse reactions” to the blood thinner, the statement said. Heparin processed by S.P.L. has been linked to 19 deaths in the United States and was found to contain an unidentified contaminant." [New York Times]

3 Japanese firms recall heparin -- chicagotribune.com

3 Japanese firms recall heparin -- chicagotribune.com: "In a blow to a Wisconsin-based maker of the blood thinner heparin's active ingredient, three Japanese companies recalled the product as a 'precautionary step' because of worries about its link to Chinese manufacturing, the Food and Drug Administration said Monday." [Chicago Tribune]

German authorities recall local version of blood thinner heparin, believed to have China link - BostonHerald.com

German authorities recall local version of blood thinner heparin, believed to have China link - BostonHerald.com: "Germany’s medical authority said Friday it has recalled a locally produced version of the blood thinner heparin believed to be linked to contaminated ingredients from China after 80 patients suffered adverse reactions.

Axel Thiele, a spokesman for the Federal Institute for Drugs and Medical Devices, told The Associated Press the drug, produced by RotexMedica GmbH, was pulled from the market Wednesday night after 80 patients suffered shortness of breath, low blood pressure and episodes of an overly rapid heartbeat." [Boston Herald]

Germany asks firms selling blood thinner heparin to examine stocks for contamination - International Herald Tribune

Germany asks firms selling blood thinner heparin to examine stocks for contamination - International Herald Tribune: "Companies in Germany that sell heparin, a drug used to thin blood, have been ordered to test their stocks for any signs of contamination, a week after a company recalled several batches because 80 dialysis patients fell sick.

Ulrich Hagemann, who oversees pharmaceutical safety for the Federal Institute for Drugs and Medical Devices, or BFARM, said the directive was issued as 'a precautionary measure.' He added no new cases of adverse reactions had been found among patients using heparin." [IHT.com]

Jury hands Merck a split decision on Vioxx cases - Examiner.com

Jury hands Merck a split decision on Vioxx cases - Examiner.com: "A state jury dealt Merck & Co. a mixed verdict Friday in the drugmaker's latest trial over its former painkiller Vioxx.

The Atlantic City jury ruled Merck was negligent and did not properly warn doctors about the cardiovascular risks in the case of one former Vioxx user who survived a heart attack. The ruling sets the stage for a second trial phase, starting Monday, to consider whether Vioxx caused the heart attack suffered by Frederick 'Mike' Humeston, 61, of Boise, Idaho, and whether he deserves compensatory damages." [Examiner.com]

APP.COM - Whistleblower takes on J&J | Asbury Park Press Online

APP.COM - Whistleblower takes on J&J | Asbury Park Press Online: "A former vice president at two Johnson & Johnson subsidiaries claims in a lawsuit he was fired for seeking recalls of numerous faulty products, including the Ortho Evra birth control patch, itself the subject of at least 1,000 product liability suits." [Asbury Park Press]

Hormone therapy can increase blood-clot risk - The Clarion-Ledger

Hormone therapy can increase blood-clot risk - The Clarion-Ledger: "Although most women can take hormones with minimal risk, some may experience heart attacks or strokes because of blood clots. The Ortho Evra birth control patch now comes with a warning that it releases more estrogen into the bloodstream than typical birth control pills. This may increase the risk for blood clots." [Clarion-Ledger]

Ortho Evra News

Ortho Evra News: "The mother of a woman who died while using a popular birth-control patch has filed a wrongful-death lawsuit against the maker of the patch, which she says caused her daughter's death." [Topix]

Women sue over birth-control patch - Women's Health - MSNBC.com

Women sue over birth-control patch - Women's Health - MSNBC.com: "More than 40 women sued the makers of a popular birth-control patch Wednesday, claiming the contraceptive caused serious illnesses and at least one death." [MSNBC]

Pill makers curry favor by touting convenience - Nashville, Tennessee - Monday, 11/27/06 - Tennessean.com

Pill makers curry favor by touting convenience - Nashville, Tennessee - Monday, 11/27/06 - Tennessean.com: "The hormone estrogen in these contraceptives is the main culprit in the increased risk of clots. In September, the FDA added a new warning label to Ortho Evra, the popular birth control patch, saying that it delivers up to 60 percent more estrogen than most daily birth control pills." [RCTimes]

TheStar.com - Birth control patch warning

TheStar.com - Birth control patch warning: "Health Canada is warning Canadian women that use of a birth control patch may increase their risk of developing blood clots in the legs and lungs." [Toronto Star]

Birth control patch warning about blood clots - Evra contraceptive patch - Health Canada

Birth control patch warning about blood clots - Evra contraceptive patch - Health Canada: "Janssen-Ortho Inc., in consultation with Health Canada, wishes to highlight important new safety information pertaining to Evra. The Evra transdermal system marketed in Canada contains 6.0 mg norelgestromin (NGMN) and 0.60 mg ethinyl estradiol (EE) and is approved for use in contraception (prevention of pregnancy)." [SpiritIndia]

Merck to Face 40,000 Vioxx Suits, Officials Say - Los Angeles Times

Merck to Face 40,000 Vioxx Suits, Officials Say - Los Angeles Times: "Merck & Co. will face about 40,000 claims over its withdrawn Vioxx painkiller once deadlines for filing lawsuits lapse around the U.S., court records and lawyer estimates show. " [LATIMES.com]

More than 14,000 Vioxx cases strain Atlantic County court

More than 14,000 Vioxx cases strain Atlantic County court: "The court charged with handling about 14,000 Vioxx-related cases that have been filed in the last two years has asked for additional help to handle its workload.

The Atlantic County Civil Division is handling the thousands of cases filed against Whitehouse Station, N.J.-based Merck over the painkiller it pulled from the market in 2004, saying its own research showed the drug doubled risk of heart attack and stroke with long-term use." [KATC.com]

Judge Orders Merck to Reveal Trial Cost,

Judge Orders Merck to Reveal Trial Cost,: "A N.J. judge ordered Merck & Co. on Tuesday to release records on how much it spent on a trial involving its Vioxx painkiller.

The information would provide a window into how much Merck spends on its trials, and what its legal defense costs could be in the future. More than 21,000 suits have been filed against Merck, which has vowed to try each case over Vioxx." [Chron.com]

How The Journals Are Cracking Down

How The Journals Are Cracking Down: "With concerns about conflicts of interest on the rise, many medical journals are cracking down. Some are demanding more detailed disclosures from authors about how they're compensated by companies, and many are more skeptically scrutinizing papers that academic and company scientists produce together. " [BusinessWeek]