More on prasugrel: what the FDA doesn’t want you to know 1

The FDA appears to have incompletely scrubbed redacted text from the PDF documents posted on its web site. Two major issues:

Prasugrel’s FDA outlook appears brighter 1

Next Tuesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee will help decide the fate of prasugrel (Effient), Lilly’s highly anticipated and somewhat controversial antiplatelet drug that many have predicted could be the next clopidogrel.

The FDA has released its briefing documents for the meeting, and the bottom line is that prasugrel’s path to approval…


Lancet editorial: OTC orlistat not in the public interest Reply

Orlistat should not be available over-the-counter, according to a Lancet editorial. Orlistat recently received OTC approval in Europe and is already available OTC in the USA. According to the editorial, “better accessibility to orlistat may not necessarily be in the best interests of the public. Orlistat has limited effect in the management of obesity—the average weight loss per year is only 2.5 kg. Making this drug available OTC will add false credibility to the notion that there is an easy pill-popping solution to obesity rather than long-term lifestyle changes.”

Urine test for CAD in the future? Reply

A group of European and Australian researchers have taken the first step toward developing a urine test to detect coronary artery disease (CAD). In a new study in the Journal of Proteome Research, the team performed a urine proteomic analysis to identify a combination of 17 proteins associated with angiographically detected CAD. Don’t go looking for a clinical test anytime soon, but this may be a hint of the future.


Generic metoprolol succinate shortage causing problems 1

The Wall Street Journal Health Blog is reporting that a shortage of generic metoprolol succinate is causing trouble for some patients. Following an FDA warning last year, Sandoz recalled 6 millions bottles of the generic drug. Then, earlier, this month, KV Pharmaceutical stopped making its version of the drug. Some insurers won’t reimburse for AstraZeneca’s brand name Toprol XL and some patients are being switched to metoprolol tartrate (Lopressor).

Abbott’s Xience V claims bragging rights as top-selling stent Reply

The economy may be in the dumps but today Abbott reported 10% growth in the last quarter. In addition to strong sales for its blockbuster Humira, company growth was fueled by rapidly growing sales of its Xience V drug-eluting stent. According to Abbott, the Xience V became the US market leader in the fourth quarter.

The Abbott upswing is partly a reflection of a general recovery in confidence with drug-eluting stents, which have now recaptured 70% of the stent market.

How does the media report on cardiovascular genetics? Reply

Last week Nature Genetics published– and we duly reported– an important study identifying a newly identified genetic mutation associated with cardiomyopathy that is widely prevalent in India.

If you’re interested in the way important studies like this get translated in the media, you should take a look at a recent entry in the Knight Science Journalism Tracker blog. The blog,