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New Evidence Fuels Concerns About The Safety Of Niacin

The string of failures– for HDL therapies in general and for niacin in particular– continues unabated.  The publication of the main results of the HPS2-THRIVE trial, along with new information from the AIM-HIGH trial, provide no evidence of a beneficial effect for niacin but do fuel concerns that it may cause serious adverse effects. 11 more words

Policy & Ethics

FDA Once Again Reaches Conclusions At Odds With Its Own Staff

Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists.  Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). 105 more words

Policy & Ethics

FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant

A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the  55 more words

Policy & Ethics

Controversial Trial Finds No Benefit For Expensive Medicines Company Drug

Although there is broad consensus in the medical community that primary PCI is the best treatment for heart attack patients when it can be delivered promptly, there is no agreement about the best accompanying drug regimen, which usually entails a combination of antiplatelet and antithrombotic drugs. 43 more words

Policy & Ethics

Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy

In response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck. 92 more words

Policy & Ethics

FDA Ends Olmesartan Safety Review, But...

The FDA announced on Tuesday that it had completed its safety review of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when results from the ROADMAP trial showed that patients with type 2 diabetes taking olmesartan had an increased risk of cardiovascular death. 32 more words

Policy & Ethics