MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'actos avandia'. Sat, 03 Sep 2011 02:15:28 +0100 http://www.medworm.com/index.php?rid=3994339&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnsBOtxToxvU%2F In a move that many anticipated, the FDA is leaving the controversial Avandia diabetes pill on the market, but with restrictions for patients who are unable to control their illness by using other meds. In a statement, FDA commish says the step is an effort to “strike the right balance to support clinical care.” Want to know about the agency thinking behind this decision? You can read recommendations from several FDA officials right here. At the same, though, the European Medicines Agency is suspending use of Avandia (here is the statement), but not revoking approval. Hamburg says there was coordination, but the FDA conducted analysis of raw data, while the EMA does not. The difference in regulatory action is based on “different regulatory tools.” GlaxoSmithKline, whic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994339 Thu, 23 Sep 2010 16:04:42 +0100 3994339 http://www.medworm.com/index.php?rid=3903131&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP3uVVkzjbQE%2F Just as the FDA decides the fate of the controversial Avandia diabetes pill, a new study finds the drug has the same cardiovascular risk as the rival Actos medication. In the latest analysis, about 4 percent of patients taking either pill suffered a heart attack, heart failure, both or died over a 33-month period. The study was publish in Circulation: Cardiovascular Quality and Outcomes (see abstract). How these results may sway the FDA is unclear. Previous studies - such as this study in the Journal of the American Medical Association - have indicated that cardiovascular risk was greater with GlaxoSmithKline’s Avandia than Takeda’s Actos. You may recall that an FDA advisory panel last month voted to allow Avandia to remain on the market, but recommended restrictions. The agenc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3903131 Wed, 25 Aug 2010 12:47:07 +0100 3903131 http://www.medworm.com/index.php?rid=3896091&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZvLxhdlArQ8%2F Avandiagate, as some have called it, appears to be never ending. In the latest twist, a letter and accompanying memo that GlaxoSmithKline wrote and distributed at the behest of the FDA is now itself the subject of a flap because some experts say the contents are misleading. And this occurs just as the agency gets set to decide the fate of the controversial Avandia diabetes pill, The New York Times writes. The letter was supposed to bring doctors up to date on two things - the outcome of a recent FDA advisory committee meeting about Avandia, which the panel decided should remain on the market but with restrictions, and a decision by the FDA to halt Glaxo’s TIDE clinical trial designed to assess cardiovascular risk when compared with the rival Actos drug (background here and here). The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3896091 Mon, 23 Aug 2010 18:41:16 +0100 3896091 http://www.medworm.com/index.php?rid=3798817&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F38ur4DbHE_o%2F File this under ‘kick ‘em when they’re down.’ Given the problems that Johnson & Johnson is having with its numerous pediatric over-the-counter meds thanks to quailty control problems that shut down a key plant, one would expect rivals to step up their advertising. Novartis, however, is going further with plans to give away 250,000 bottles of Triaminic Fever Reducer Pain Reliever between Aug. 2 and 8 (look here). “If you are going to take on children’s Tylenol, now is the time to do it,” Mick Kolassa, who heads the Medical Marketing Economics consulting firm, tells The New York Times. “It’s a beautiful opportunity. There’s concern. There’s a shortage. There’s a wide opening in the marketplace…It’s saying, okay, you’ve gotten rid of the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3798817 Thu, 29 Jul 2010 00:07:22 +0100 3798817 http://www.medworm.com/index.php?rid=3790923&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9PSZP9s4wQg%2F Remember David Capuzzi? He was a member of the recent FDA advisory committee on Avandia who, as it turns out, has also been a speaker for GlaxoSmithKline, which sells the controversial diabetes pill. The FDA, apparently, was not aware of this relationship until it was disclosed last week (see here). Capuzzi, who is a professor of medicine and biochemistry at Thomas Jefferson University in Philadelphia was paid a total of $14,750 over the past several years, mostly for talking about Lovaza, including at least one engagement earlier this year. But there was once instance in which he spoke about Avandia, according to a Glaxo spokesman. When asked about this last week, the FDA issued a statement saying the agency “takes these allegations very seriously and is investigating the matter.”... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3790923 Mon, 26 Jul 2010 12:08:13 +0100 3790923 http://www.medworm.com/index.php?rid=3776608&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjnP39jtGtgs%2F Less than a week after an FDA advisory panel voted to allow the controversial Avandia diabetes pill to remain on the market - but with either warnings or restrictions - the agency says new patients should not be enrolled in a long-term, randomized, controlled study known as the TIDE trial, which is designed to compare the drug with the rival Actos pill (see the FDA statement). The trial has been criticized for being unethical, since it compares one pill with known cardiac risks, GlaxoSmithKline’s Avandia, with a seemingly safer alternative (back story here. To gain some guidance and political cover, FDA commish Margaret Hamburg recently asked an Institute of Medicine committee to explore the ethical issues the FDA faces when requiring a drugmaker to run a randomized clinical trial f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3776608 Wed, 21 Jul 2010 17:00:30 +0100 3776608 http://www.medworm.com/index.php?rid=3776609&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FG7wD-XKMv5o%2F Twice this week, we have learned that members of the FDA advisory panel convened to review the safety of the Avandia diabetes pill had relationships with drugmakers that had something at stake. One panelist, David Capuzzi, has an ongoing relationship with GlaxoSmithKline as a speaker, although he apparently spoke only once about the diabetes drug (see here). And Abraham Thomas has, in the past, given talks about Actos, a rival pill sold by Takeda Pharmaceuticals (see here). The FDA is now investigating the episode surrounding Capuzzi and expects to have some decision by the end of the week. A finding that warrants further inquiry could be sent to the HHS Office of Inspector General. The agency, however, may not probe Thomas, because his speaking engagements for Takeda took place more than ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3776609 Wed, 21 Jul 2010 16:29:54 +0100 3776609 http://www.medworm.com/index.php?rid=3772463&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAdAiMj9PocE%2F Another day, another conflict involving the FDA advisory panel held last week to review the Avandia diabetes pill. As it turns out, a doctor who voted against leaving Avandia on the market was a paid speaker for Takeda Pharmaceutical, which sells the rival Actos drug. The panel member is Abraham Thomas, who heads the endocrinology and diabetes division at Henry Ford Hospital in Detroit, according to The Wall Street Journal. A Takeda spokewoman confirms that Thomas was a member of its Diabetes Speakers Bureau from September 2007 and September 2008, and gave two presentations for which he was paid between $2,000 and $3,000, but is no longer part of the program (see a recent disclosure here). “I do not remember there being any issue brought up about the Takeda speakers bureau” by ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772463 Tue, 20 Jul 2010 20:07:48 +0100 3772463 http://www.medworm.com/index.php?rid=3758109&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQxQKT1gwgt4%2F This is hardly surprising, but worth noting, nonetheless. Now that a majority of FDA advisory panel members voted in favor of allowing GlaxoSmithKline’s Avandia diabetes pill to remain on the market - but with restrictions - Takeda Pharmaceuticals is taking advantage by running a national media blitz over the next two weeks in newspapers and magazines. The ads, which brag that “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke,” are appearing in 154 publications spanning 85 different markets. The national publications include The New York Times, USA Today and The Wall Street Journal, as well as such magazines as Parade, Newsweek, Time and BusinessWeek. Of course, the Avandia story is not over - 12 FDA panelists voted t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3758109 Thu, 15 Jul 2010 20:45:07 +0100 3758109 http://www.medworm.com/index.php?rid=3758104&cid=t_215547_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F07%2Factos-launches-dtc-attack-on-avandia.html Ha! Takeda's sneak attack: Launches Actos DTC campaign today, a day that will live in infamy! Read the story here. (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3758104 Thu, 15 Jul 2010 20:14:00 +0100 3758104 http://www.medworm.com/index.php?rid=3754074&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl41fGsGFSqE%2F And so the vote is in - 20 FDA advisory committee members voted for GlaxoSmithKline’s Avandia diabetes pill to remain on the market, but with either restrictions or labeling changes. By comparison, 12 panel members voted to withdraw the drug. There was one abstention. The FDA doesn’t have to follow the advice of its panels, but generally does. And so, FDA officials face a Solomon-like situation - instead of maintaining the status quo or withdrawing the drug, they have impetus to develop a package of caveats that will appease some doctors and patients who maintain Avandia is their best choice, despite the cardiovascular risks. This possibility suggests Avandia could remain available elsewhere, although European regulators hold their own review next week. For Glaxo, the outcome i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3754074 Wed, 14 Jul 2010 20:38:05 +0100 3754074 http://www.medworm.com/index.php?rid=3754076&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fxlpyt1HdMrc%2F After years of debate, mountains of data, harsh opinions, corporate intrigue and agency infighting, the FDA advisory committees today will vote on the fate of GlaxoSmithKline’s Avandia pill. There are, of course, numerous and copious arguments for withdrawing the drug, given the evidence indicating greater cardiovascular risk and concerns over the way Glaxo handled its own data. But there is also the nagging thought that, perhaps, Actos shows a greater risk for bladder cancer. And what about those patients for whom another treatment may not work, or work as well? Some doctors have already switched their patients (see this), and no doctor wants to keep a patient on a potentially risky medicine. But is it possible Avandia can remain available as a treatment of last resort, complete wit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3754076 Wed, 14 Jul 2010 16:54:09 +0100 3754076 http://www.medworm.com/index.php?rid=3750269&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FowzUueMZMKk%2F By now, the name Rosemary Johann-Liang may sound familiar. She is the former FDA medical reviewer who left the agency three years ago amid controversy over her work on GlaxoSmithKline’s Avandia diabetes pill (background links here). Johann-Liang had pressed for stiffer warnings on the drug, but was rebuked and excluded from safety meetings. More recenty, she was deposed as part of litigation over cardiovascular risks associated with the drug. The deposition was not included in a letter sent by the US Senate Finance Committee to FDA commish Margaret Hamburg yesterday in which new allegations were leveled at the drugmaker for failing to disclose a study that allegedly provided greater understanding of cardiovascular risks. However, it was not released publicly and we now have the depositio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750269 Tue, 13 Jul 2010 17:24:10 +0100 3750269 http://www.medworm.com/index.php?rid=3750273&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FA9oLchiBF7k%2F Nothing like dropping a bombshell on the morning of a crucial FDA advisory committee meeting. But GlaxoSmithKline quietly began a study in 1999 to determine if the cardiovascular risks of its Avandia diabetes pill were greater than with Actos, a similar drug, and instead of publishing the results, the drugmaker spent 11 years trying to cover them up, according to The New York Times. The results were never provided to the FDA or posted on the Glaxo web site, the paper continues, citing these documents - please see Attachments A and E. “This was done for the US business, way under the radar,” Martin Freed, a SmithKline exec, wrote in a March 29, 2001, e-mail about the results. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.” The study w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750273 Tue, 13 Jul 2010 12:30:43 +0100 3750273 http://www.medworm.com/index.php?rid=3746986&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-CbIiY0mVwQ%2F This report could change the Avandia game entirely. For one, if Marciniak’s view is widely held at the FDA (or it’s widely shared among its advisory committee), then we no longer have a case in which the clinical trials point one way and the observational evidence points the other way. More important, because Marciniak is a CDER reviewer, we no longer have a case in which the FDA’s ‘trialists’ are entirely at odds with its ‘observationalists.’ In other words, Marciniak’s memo may create doubt among many CDER medical reviewers who favor randomized clinical trials but who may come to doubt GSK’s credibility in running them. That kind of loss of trust can be severely destructive for a company. As far as I can tell, Marciniak’s voice is a new one in this debate, and combine... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3746986 Mon, 12 Jul 2010 13:09:05 +0100 3746986 http://www.medworm.com/index.php?rid=3706994&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FennOAQ5bM08%2F Just three weeks before what is certain to be a tense FDA advisory committee meeting, the study showing the Avandia diabetes pill increases the the risk of stroke, heart failure and death compared with Takeda Pharmaceutical’s Actos has been peer-reviewed and published (see this). This is the same paper that was leaked to us earlier this month (see here) and now appears online at the Journal of the American Medical Association web site. The study, which evaluated data from 227,571 Medicare patients between 2006 and 2009 with an average of 74.4 years, found there 1,746 heart attacks, of which 21.7 percent fatal; 1,052 strokes and 7.3 percent fatal; 3,307 hospitalizations for heart failure, including 2.6 percent that were fatal; and 2,562 deaths for all causes. Although the analysis sh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3706994 Mon, 28 Jun 2010 14:18:07 +0100 3706994 http://www.medworm.com/index.php?rid=3679914&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMXgDoWb_u_s%2F A sunny day here on the Pharmalot corporate campus, where we are using some spare moments to catch up on our reading. And of course, we are leisurely quaffing a few cups of stimulation. Later, we plan to grab a bite with Mrs. Pharmalot and The Pharmalittles in honor of you-know-what day. Whatever your plans, we hope the day is enjoyable. Meanwhile, here are a few stray items to keep you fresh. And remember to say hi to your dad. Have a great time… Patents on blockbusters are expiring. The human genome is not delivering. And the low-hanging fruit was long ago picked from the orchard of obvious follow-ups. Adrian Ivinson, director of Harvard’s NeuroDiscovery Center, is reminded of the shifts underway in the industry every time he looks out of his Cambridge, Ma., window at the “... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3679914 Sun, 20 Jun 2010 14:13:01 +0100 3679914 http://www.medworm.com/index.php?rid=3648798&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIMny61PkBdU%2F A new observational study comparing the controversial Avandia diabetes pill found an increased risk of various cardiovascular problems compared with Actos, a similar drug but one that hasn’t raised as many concerns. Yet one co-author, FDA reviewer David Graham, recently wrote top FDA officials over concerns that agency supervisors hadn’t given clearance for the study to be submitted for publication. (You can see Graham’s email to FDA commish Margaret Hamburg further down). The May 28 draft manuscript indicates the authors reviewed records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills. The results - GlaxoSmithKline’s Avandia increased the risk of stroke by 27 percent; hear... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3648798 Thu, 10 Jun 2010 16:07:11 +0100 3648798 http://www.medworm.com/index.php?rid=3652693&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIMny61PkBdU%2F A new observational study comparing the controversial Avandia diabetes pill found an increased risk of various cardiovascular problems compared with Actos, a similar drug but one that hasn’t raised as many concerns. Yet one co-author, FDA reviewer David Graham, recently wrote top FDA officials over concerns that agency supervisors hadn’t given clearance for the study to be submitted for publication. (You can see Graham’s email to FDA commish Margaret Hamburg further down). The May 28 manuscript indicates the authors reviewed records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills. The results - GlaxoSmithKline’s Avandia increased the risk of stroke by 27 percent; heart fail... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3652693 Thu, 10 Jun 2010 15:33:43 +0100 3652693 http://www.medworm.com/index.php?rid=3581838&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7jADiryRMOk%2F The big drugmaker is having difficulty recruiting patients for the TIDE trial, which compares the Avandia diabetes pill with Takeda Pharmaceutical’s Actos, but there are ongoing concerns that the study is unethical because it tests a drug with known cardiac risks with what appears to be a safer alternative. And now investigative sites have withdrawn due to poor enrollment, The Wall Street Journal reports. One site, Wake Forest University Baptist Medical Center in North Carolina, is “not succeeding in recruiting anybody,” although efforts to enlist patients began last year, William Applegate, dean of Wake Forest’s medical school, tells the paper. The FDA, meanwhile, is considering putting an end to the trial (see here) and some physicians agree it should be ended (look h... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3581838 Thu, 20 May 2010 12:29:07 +0100 3581838 http://www.medworm.com/index.php?rid=3515635&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjIXtyqL7RSU%2F Yesterday, the House Agriculture FDA Appropriations Subcommittee held a hearing on drug safety with a special emphasis on Avandia, the GlaxoSmithKline diabetes pill that has been linked to heart problems amid controversy over the extent to which the drugmaker disclosed the risks. The hearing comes two months after the Senate Finance Committee released a report detailing internal disagreement within the FDA and new revelations about Glaxo deliberations. Meanwhile, the FDA plans an advisory committee meeting in July, but may halt a 16,000-patient safety study called TIDE over ethics concerns (background). Here’s what a few of those speaking had to say…. Rosa DeLauro, subscommittee chair: When this drug was approved in 1999, the FDA requested the Glaxo conduct a post-market study,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3515635 Thu, 29 Apr 2010 12:52:32 +0100 3515635 http://www.medworm.com/index.php?rid=3508447&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcHEwkbD7WIg%2F Is the TIDE trial going to get derailed? The FDA is already considering whether the studyl, which compares GlaxoSmithKline’s Avandia with Takeda Pharmaceutical’s Actos, should continue over concerns that it may be unethical to compare a drug with known cardiac risks with what appears to be a safer alternative (see here). The deliberations occur in the run-up to an FDA advisory committee meeting in July to review Avandia and cardiac risks. Now, some physicians are telling heartwire that the trial, which is supposed to involve thousands of patients, should be stopped, in part because informed consent forms may not reflect the most up-to-date Avandia safety info, an issue that FDA commish Margaret Hamburg alluded to in a recent letter to US Senator Chuck Grassley, who is investiga... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3508447 Tue, 27 Apr 2010 12:43:50 +0100 3508447 http://www.medworm.com/index.php?rid=3483117&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8YlODPoiDBY%2F The FDA may halt a safety study involving patients taking GlaxoSmithKline’s Avandia diabetes pill, which could also determine whether the drug stays on the market, The Wall Street Journal reports. You may recall recent studies tied the med to an increased risk of heart attacks, and in 2007, the FDA approved a trial comparing Avandia with Takeda Pharmaceutical’s Actos, which hasn’t generated the same degree of safety concerns. But some scientists say it is unethical to compare a drug with known cardiac risks with a seemingly safer alternative, and that Avandia should be pulled from the market. For several years, the FDA pooh-poohed these concerns, but has now called in the Institute of Medicine to review the ethics of head-to-head studies, according to the Journal. In a le... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3483117 Mon, 19 Apr 2010 12:35:24 +0100 3483117 http://www.medworm.com/index.php?rid=3383081&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCvh0VnrwATI%2F And so the debate over untoward conflicts of interest rages on. The latest installment is brought to you by BMJ, which has published a paper by a team of Mayo Clinic Researchers, who found most scientists who published articles supporting GlaxoSmithKline’s Avandia diabetes pill after it was linked to a risk of heart attacks in 2007 had financial ties to the drugmaker. Of 202 articles reviewed, 108 - or 53 percent - had a conflict of interest statement, and 90 authors, or 45 percent, had financial conflicts of interest. Authors with a favorable view of the risk of heart attack were more likely to have financial conflicts of interest with makers of antihyperglycaemic drugs, in general, and with drugmakers who sell Avandia and similar pills - Eli Lilly and Takeda - than authors who had ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3383081 Fri, 19 Mar 2010 12:05:06 +0100 3383081 http://www.medworm.com/index.php?rid=3290991&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzmPNNoYg-CQ%2F Avandia is needlessly causing hundreds of cases of heart attacks and heart failure each month, according to confidential government reports, The New York Times writes. Moreover, if every diabetic taking Avandia were given Actos instead, about 500 heart attacks and 300 cases of heart failure would be avoided each month. The pill was linked to 304 deaths during the third quarter of 2009, and a report by the FDA’s David Graham and Kate Gelperin concludes the pill should be yanked (Graham said this in 2007 - look). Some FDA officials want Avandia withdrawn because they believe a safer alternative exists, the Times adds, noting others insist studies offer contradictory info and Avandia should remain an option. GlaxoSmithKline, which makes the pill, says it studied Avandia extensively and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3290991 Sat, 20 Feb 2010 15:29:18 +0100 3290991 http://www.medworm.com/index.php?rid=3290989&cid=t_215547_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F02%2Fgsk-avandia-rosiglitazone-should-be.html Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.More from Gardiner Harris at the NYT (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3290989 Sat, 20 Feb 2010 04:55:00 +0100 3290989 http://www.medworm.com/index.php?rid=2716033&cid=t_215547_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FD6BYhuhwrLU%2F Avandia (rosiglitazone), a medication for people with type 2 diabetes, has been the subject of studies evaluating its safety and the results aren’t what Glaxo (the manufacturer) had hoped for. According to researchers in Toronto, Canada, elderly people who take Avandia may have an increased risk of heart failure and death. The researchers didn’t, however, find the same results that American researchers found two years earlier, which suggested that Avandia also increased the risk of heart attacks. The Canadian researchers found no difference between patients who took Avandia and another type of medication, Actos (pioglitazone), and the rate of heart attacks among them The researchers studied 40,000 patients over the age of 65 who took Avandia or Actos. For every 93 patients, the... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2716033 Wed, 19 Aug 2009 12:54:58 +0100 2716033 http://www.medworm.com/index.php?rid=2033599&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F481603244%2F The long-term use of the so-called glitizones, a popular class of diabetes pills that includes Glaxo’s Avandia and Takeda’s Actos, drugs doubles the risk of bone fractures in women with type 2 diabetes, according to a study in the Canadian Medical Association Journal. The study reviewed 10 previous clinical trials, and for every 20 women in their 70s with type 2 diabetes who took the drugs for at least one year, one has a chance of suffering a fracture. In women in their mid-50s, the figure equals one fracture in every 55 women. That’s more than double the normal risk for those age groups. An accompanying editorial concludes that “the ongoing accumulation of evidence of harm for (this class of drugs) is unsettling to clinicians and patients and threatens to undermin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2033599 Thu, 11 Dec 2008 12:10:58 +0100 2033599 http://www.medworm.com/index.php?rid=2005939&cid=t_215547_134_f&fid=35137&url=http%3A%2F%2Fdiabetesupdate.blogspot.com%2F2008%2F12%2Fnew-study-spins-actos-health-risk-but.html The bad news about Avandia's association with heart attack has been good news for Takeda, the maker of Actos. Both drugs are thiazolidinediones (TZD). They help lower blood sugar by reducing insulin resistance. Until the ACCORD study results came out last year, Avandia was prescribed far more frequently than Actos. Now, with Avandia's reputation in tatters, Takeda has been pushing doctors to switch their Type 2 patients to Actos.The latest effort in this direction was the publication of a new study that is being spun in the media as showing the Actos is far safer than Avandia. Here's a link to the actual study: Comparison of Cardiovascular Outcomes in Elderly Patients With Diabetes Who Initiated Rosiglitazone vs Pioglitazone Therapy. Wolfgang C. Winkelmayer, MD, ScD; Soko Setoguchi, MD, Dr... Diabetes Update blogs http://www.medworm.com/rss/comments.php?id=2005939 Mon, 01 Dec 2008 20:34:00 +0100 2005939 http://www.medworm.com/index.php?rid=1990761&cid=t_215547_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F11%2Fglitazone-wars-this-just-in.html "Those who started with rosiglitazone had a 15 percent increased risk of dying from any cause compared with pioglitazone." Reuters (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1990761 Tue, 25 Nov 2008 12:01:00 +0100 1990761 http://www.medworm.com/index.php?rid=1969317&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F457574314%2F An increasing number of type 2 diabetes patients in the US are being treated by an increasingly complex mix of therapies, according to a study in the Archives of Internal Medicine, which questions whether the meds are actually going to improve outcomes. Between 1994 and 2007, the estimated number of yearly patient visits to treat diabetes increased from 25 million to 36 million. During the period reviewed by the study, the number of doctor visits in which only one drug was prescribed decreased from 82 percent to 47 percent, and the average number of medications prescribed per treated patient rose from 1.14 to 1.63. By 2007, biguanides (54 percent of treatment visits) and glitazones (28 percent of visits) were leading therapeutic classes. Increasing use of glitazones, newer insulins, sitag... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1969317 Tue, 18 Nov 2008 20:11:19 +0100 1969317 http://www.medworm.com/index.php?rid=1750366&cid=t_215547_134_f&fid=36049&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FDiabetesNotes%2F%7E3%2FeRv5j_-NK6s%2F Will you continue to take Avandia or Actos regardless of the new findings? Yes, it works for me I will follow my doctors advice No- way! I already stopped taking it View Results Share This (Source: Diabetes Notes) Diabetes Notes blogs http://www.medworm.com/rss/comments.php?id=1750366 Sun, 31 Aug 2008 22:48:12 +0100 1750366 http://www.medworm.com/index.php?rid=1750367&cid=t_215547_134_f&fid=36049&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FDiabetesNotes%2F%7E3%2F4bwMuuz-7Ac%2F Over 20% of all diabetics have heart disease. That is why it is so scary when new research and studies come out that prove diabetic medication to harm your heart. And here we go again… Two Wake Forest University School of Medicine faculty members sifted through three trials to come to the conclusion that certain diabetic medications could cause increased heart failure- ACCORD, ADVANCE, and the Veterans Affairs Diabetes study. “We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market,” write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences. Rosiglitazone and pioglitazone are the two major thiazolidi... Diabetes Notes blogs http://www.medworm.com/rss/comments.php?id=1750367 Sun, 31 Aug 2008 22:44:53 +0100 1750367 http://www.medworm.com/index.php?rid=1742862&cid=t_215547_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FJsarMrAGxFA%2F Over 20% of all diabetics have heart disease. That is why it is so scary when new research and studies come out that prove diabetic medication to harm your heart. And here we go again… Two Wake Forest University School of Medicine faculty members sifted through three trials to come to the conclusion that certain diabetic medications could cause increased heart failure- ACCORD, ADVANCE, and the Veterans Affairs Diabetes study. “We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market,” write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences. Rosiglitazone and pioglitazone are the two majo... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=1742862 Fri, 29 Aug 2008 16:03:53 +0100 1742862 http://www.medworm.com/index.php?rid=1739100&cid=t_215547_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F08%2Fglitazones-heart-of-matter.html A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members.“We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market,” write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences. Rosiglitazone and pioglitazone are the two major thiazolidinediones.In the editorial Singh and Furberg say, “At this time, justification for use of thiazolidinediones is very weak to non-existent.”Oral drugs are given to control diabetes by lowering blood sugar.But diabetics al... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1739100 Fri, 29 Aug 2008 05:12:00 +0100 1739100 http://www.medworm.com/index.php?rid=1087709&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F198889436%2F Yet another study suggests problems with Avandia. This time, however, Actos also gets tagged. An article published in this week’s edition of the Journal of the American Medical Association concludes the two drugs pose a significantly greater risk of heart attack, congestive heart failure and death in older patients compared with other diabetes meds. (This is the abstract). This is only the latest difficulty for Glaxo, which has seen Avandia sales plummet this year following a controversial meta-analysis last spring that linked the drug to an increased risk of heart attacks. The FDA allowed the pill to remain on the market, but slapped a second Black Box warning on the labeling. The troubles facing the med, which was once a best seller, is now cited as a key reason for Glaxo’s p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1087709 Tue, 11 Dec 2007 23:30:55 +0100 1087709 http://www.medworm.com/index.php?rid=1072405&cid=t_215547_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F195737938%2Fdrug_warnings_and_withdrawls_f_1.html FiercePharma has compiled a list of the top 10 drugs to have who have had approval either withdrawn or been forced to add stronger warning labels, by the FDA, with respect to their pharmaceutical products.  The list is based on 2006 worldwide sales so ranking does not necessarily include the big new makers.1. Antidepressants - Various companies - "Black" box warning regarding increased risk of suicidal thoughts.2. Epogen/Aranesp - Amgen - "Black" box warning of heart and vascular risk at higher doses3. Zyprexa - Lilly - Warning of weight gain and metabolic problems4. Avandia - Glaxo - "Black" box warning of heart failure and heart attack5. Actos - Takeda - "Black" box warning of heart failure6. Provigil - Cephalon - Waning of Stevens-J... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1072405 Wed, 05 Dec 2007 20:00:41 +0100 1072405 http://www.medworm.com/index.php?rid=1055790&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F191810593%2F As we awake, we are reminded of the old adage, articulated regularly by a former morning mayor, that every brand new day should be unwrapped like a precious gift. And so we are in the process of gently pulling back the covering and celebrating our good fortune. We hope you do the same… EU And US Docs Urge More Cautious Use Of Diabetes Meds (Yahoo/Reuters) GPC Biotech Seeks A Merger Partner (Bloomberg News) Canada’s QLT Puts Itself Up For Sale (Yahoo/Reuters) Novartis Says EU Approves Tasigna (Yahoo/Reuters) Merck KgGA Starts Phase III On Parkinson’s Drug (CNNMoney.com/Thomson) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1055790 Wed, 28 Nov 2007 12:24:23 +0100 1055790 http://www.medworm.com/index.php?rid=1030257&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F185452818%2F It would only be surprising if Takeda Pharmaceuticals didn’t make such a move. The drugmaker plans to roll out ads touting the safety of its own Actos diabetes pills tomorrow - just two days after Glaxo acquiesced to the FDA and agreed to place yet another Black Box warning on Avandia product labeling. The new warning carries info about heart attack risks; an earlier Black Box mentions heart failure. Although the latest Avandia warning says that evidence is “inconclusive” about the increased risk of heart attacks, Wall Street expects the language to further dampen sales of the drug, which have plummeted since safety concerns arose in May, the Associated Press notes. And this gives Actos an advantage, because its the only diabetes drug in the same class as Avandia. Takeda ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1030257 Thu, 15 Nov 2007 23:26:40 +0100 1030257 http://www.medworm.com/index.php?rid=974715&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F174274876%2F Glaxo’s diabetes pill already has such a warning about heart failure, but apparently the FDA wants to add one about the risk of heart attacks, according to The Wall Street Journal. Talks are still under way, the paper writes, but if agency officials succeed, the move would make it still more difficult for sales to rebound. Ever since the New England Journal of Medicine published a study last May that Avandia raised the risk of heart attacks by 43 percent, the drugmaker has insisted evidence is lacking that the diabetes pill is more dangerous than rival meds. Avandia scrips, meanwhile, have continued to plunge and sales were down 38 percent in the third quarter. As the paper notes, Takeda’s Actos also carries a warning about the risk of heart failure, but not heart attack. An F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=974715 Wed, 24 Oct 2007 11:30:48 +0100 974715 http://www.medworm.com/index.php?rid=894217&cid=t_215547_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F160326364%2Factos_better_than_avandia_study_confirms.html Clinical trials results have found that patients receiving a starting dose of Takeda Pharmaceutical's diabetes drug, Actos gain better control of blood sugar and lipid levels than those using GlaxoSmithKline's Avandia.This finding comes on the heels of recent fears that Avandia increases heart attack risks. The findings are form the first 3 months of a 6 month study that pitted a 30 milligram dose of Actos against a 4 milligram dose of Avandia. Results were that Actos significantly reduced triglyceride and LDL cholesterol and increased levels of HDL cholesterol."A likely explanation for the different effects on heart attack and strokes between the two drugs could be the favorable effect of pioglitazone in increasing HDL cholesterol without adverse effects on LDL as demons... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=894217 Sun, 23 Sep 2007 19:50:09 +0100 894217 http://www.medworm.com/index.php?rid=864405&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155205504%2F More trouble for Glaxo. New studies in the Journal of the American Medical Association say that Avandia increased the chances of having a heart attack, while Takeda’s competing drug lowered the risk. The Glaxo pill increased heart attacks by 42 percent and doubled rates of heart failure. Takeda’s Actos reduced heart attacks, strokes and deaths by 18 percent, though it also increased heart failure, according to a separate study funded by the drugmaker. There’s little doubt this will make it much more difficult for Glaxo to win back market share. Avandia was the world’s best-selling diabetes pill until May, when a controversial study was reported by the Cleveland Clinic’s Steve Nissen in The New England Journal of Medicine that the pill increased heart attack r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=864405 Tue, 11 Sep 2007 21:24:36 +0100 864405 http://www.medworm.com/index.php?rid=799395&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F144157126%2F This isn’t surprising, is it? The stronger warning about the risk of heart failure will, in fact, be added to the labels for an entire class of type 2 diabetes drugs, which also includes Avandaryl, Avandamet and Duetact. The move, announced by the FDA, comes after the July 30 advisory committee meeting, in which stronger warnings and restrictions were recommended. “This new boxed warning addresses FDA’s concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure,” says Steve Galson, director of the FDA’s Center for Drug Evaluation and Research. The agency’s review of adverse event reports found an unspecified number of cases of signific... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=799395 Tue, 14 Aug 2007 21:09:29 +0100 799395 http://www.medworm.com/index.php?rid=783158&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F141304974%2F The Pink Sheet, the venerable trade publication, conducted an interesting question-and-answer interview with the controversial Cleveland Clinic cardiologist after the recent FDA advisory panel meeting, in which new, but unspecified restrictions were recommended for the Glaxo diabetes drug. This is an excerpt of what he had to say about clinical trial design, advisory panels and safety issues…. The Pink Sheet: What is the proper role of meta-analyses in drug safety oversight, and is that role changing? Steven Nissen: A meta-analysis is a fine way to assess the safety of a drug - it’s not necessarily the best way to assess the efficacy of a drug. I actually thought the committee maybe didn’t understand that. [To] put it into perspective, what the FDA did in their meta-analy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=783158 Mon, 06 Aug 2007 18:49:23 +0100 783158 http://www.medworm.com/index.php?rid=761705&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F137934060%2F Yet another meta-analysis finds Glaxo’s diabetes drug is trouble - and finds the same thing about Takeda’s Actos, too. The analysis reviewed more than 78,000 patients, and estimates that one in every 50 patients taking the drugs over a 26-month period will require hospital admission due to heart failure, PharmaTimes reports. “This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed health services,” says Yoon Loke, a clinical pharmacologist at UEA’s School of Medicine, Health Policy and Practice. The results are being published in the August edition of the journal Diabetes Care. The news comes on the eve of this Monday’s FDA panel meeting to decide whether Avandia should be yan... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=761705 Fri, 27 Jul 2007 12:02:01 +0100 761705 http://www.medworm.com/index.php?rid=737688&cid=t_215547_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F134352106%2F Like to save money and avoid health risks? Try an older diabetes med. Avandia and Actos are no more effective at controlling diabetes, and are often less safe than older meds that cost much less, according to a new report by Consumers Report. For instance, the newer meds can cost $150 to $250 a month, compared with $10 to $60 a month for older drugs, such as metformin. “This is truly significant information for the millions of people with diabetes struggling to control their disease, but also struggling with the high cost of their medications,” says Gail Shearer, project director of Consumer Reports’ Best Buy Drugs. “The evidence shows that lower-cost, older medicines work just as well for most people.” You can read the full report here. The report is based on a new analysis ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=737688 Mon, 16 Jul 2007 21:58:55 +0100 737688 http://www.medworm.com/index.php?rid=675456&cid=t_215547_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F06%2F13%2Fjanuvia-actos-set-to-benefit-from-avandias-plight%2F Filed under: Type 2, Drugs, ResearchAvandia, a drug used to treat Type 2 diabetes, has been in the news of late following the release of controversial study results which concluded the drug leaves patients at an increased risk for heart trouble. My fellow blogger Bev has touched on the conundrum now facing diabetics on Avandia regimens. You can quit taking Avandia, but then what? Thousands of Americans are now facing this predicament and many have opted to switch their prescriptions to something else. The Philadelphia Inquirer is running a feature about this and talks to some diabetics who have opted for the "try something else" route. The Inquirer profiles, among others, pharmacist Ben Briggs, 59, who switched to Merck's Januvia in the wake of the Avandia scandal, but was sorely disappoin... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=675456 Wed, 13 Jun 2007 04:00:00 +0100 675456