Wednesday, March 12, 2008

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]