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 [...]

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 [...]

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 [...]

A busy day, thanks primarily to Avandia, of course. Who says the summer is a slow time? There’s always a lot of pharma, as our name implies. With that in mind, here are a few items to tide you over until the morning…
Patients taking Takeda’s Actos diabetes drug were less likely to suffer a heart [...]

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 [...]

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, [...]

These dispatches are from the American Diabetes Association meeting in Chicago:
1 - Actos may lower the risk of heart attack and death by 44 percent in diabetic patients with kidney disease, according to one study. Another study found that the Takeda Pharmaceuticals drug reduced inflammation and blood clots more than a placebo, Bloomberg News reports. [...]

That’s what the FDA is proposing for the diabetes drugs. Two weeks ago, the FDA sent letters to Glaxo and Takeda, which sells Actos, saying the risk of heart failure posed by these meds warrants black box warnings.
“FDA decided to make this request because, despite the existing warnings, these drugs were being prescribed to patients [...]

In a research note issued this morning, Barbara Ryan of Deutsche Bank writes that IMS data for the week ending May 25 indicate a “substantial hit” to Avandia scrips. The biggest winner is Takeda’s Actos, although Merck’s Januvia is benefitting, too.
IMS audit levels point to overall increase of roughly 6 percent and 3 percent for [...]