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No more Niacin and fibrates with Statins: USFDA


No more Niacin and fibrates with Statins: USFDA

The Food and Drug Administration  (FDA ) is withdrawing its earlier approval  related to co administration  with a statin for Niacin extended release tablets and fenofibric acid delayed release capsules. The decision of the FDA comes in the face of these medicines being ineffective in the treatment of high cholesterol levels.

The FDA’s withdrawal of approval  will affect  niacin extended-release (Niaspan, AbbVie) and fenofibric acid (Trilipix, AbbVie), as well as AbbVie’s Advicor and Simcor, both  combining niacin with a statin.

According to a notification, issued by the FDA , Docket No. FDA-2016-N-1127, ‘no incremental benefit of Niaspan co administered with simvastatin or lovastatin on cardiovascular morbidity and mortality has been  observed.’ The notification further  adds that ‘addition of Niaspan did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in  large, randomized controlled trials.’

The FDA  justifying its decision to withdraw approval on  Fenofibric Acid DR capsules ,Trilipix  ( introduced by it in 2008), indicates that the capsule,  an adjunct to diet in combination with a statin, to reduce Triglyceride and increase HDL-Cholesterol in patients, with mixed dyslipidemia and CHD (coronary heart disease), has been found to be ineffective.

Based on  collective evidence from several large cardiovascular outcome trials,  the FDA  notification says that it had been concluded that the totality of the scientific evidence no longer supported  the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL cholesterol levels in statin-treated patients, resulted in a reduction of risk of cardiovascular events, on administration of the drug.

Thereby , allowing the  FDA to conclude  that the benefits of niacin ER tablets and fenofibric acid DR capsules, for co administration with statins no longer outweighed  the risks, and the approvals for this, in all necessity, be withdrawn.

A similar thought  process has dictated the authorities pulling back their  approval of Advicor (niacin extended-release/lovastatin) and Simcor (niacin extended-release/simvastatin).  Abbvie voluntarily pulled off the drugs from marketing shelves at the end of 2015. .



Source: self
1 comment(s) on No more Niacin and fibrates with Statins: USFDA

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  1. Role of Fibrates — What I’ve been saying since last two years has now been taken action on ! I stopped the combination of statin with Fibrates use since last two years.