Sunday, January 19, 2014

Merck Pulls Liptruzet as New Drug is Approved

The giant drug maker Merck & Co based in Whitehouse Station N.J. announced Tuesday that it is recalling the cholesterol drug Liptruzet due to packing defects and concerns over effectiveness. The recall comes in the same week that the FDA’s Cardiovascular Renal Drugs Advisory Committee voted 10-1 in favor of approving Merck’s new drug Vorpaxar despite concerns discovered while the drug was under study.

Merck has agreed to remove all of the drug Liptruzet from U.S. availability, and to wipe out the entire stock. Both of the active ingredients in the drug will remain available in American separately.  Merck the third largest supplier of pharmaceutical drugs has state public that it agrees with findings regarding problems with the foil pouches holding the pills, and a possibility does exists that air and moisture could enter the pouches reducing the effectiveness of the drug. Merck has stressed to the media the recall is based on this possibility only, and currently there are no reports of patients coming to harm from taking damaged or ineffective Liptruzet.

Liptruzet was in use to reduce levels of LDL typically referred to as “bad cholesterol”. The purpose of the drug is to decrease a patient’s chances of developing the risk factors that can lead to a heart attack or stroke. The two ingredients used in Liptruzet were Merck’s own drug Zetia used to decrease the amount of cholesterol found in food, and atovastain, which lowers the natural production of cholesterol in the body.  Atovastain is a generic version of Lipitor a drug first marketed by Pfizer, but that has now entered generic competition.

Merck has informed the media that patients should continue taking any Liptruzet they have currently, and a consult a doctor before stopping. The company will repackage this drug and hopes to have it back on the market soon.

Merck’s new thrombin receptor antagonist vorapaxar got the go ahead after the FDA’s panel’s 10-1 decision. Mori Krantz of The University of Colorado was the one dissenting vote, but he did state this was a “formal dissent” out of concerns regarding bleeding complications observed while the product was under study. He went on to state in his opinion that he was not “entirely opposed” to the drug’s release, but remained concerned that in real world use the conditions found in the study could be amplified.

Others on the panel found that Merck had convincing proved that the benefits of vorpaxar which has been demonstrated as effective in reducing the chances of stroke in the post-MI population was enough to out weigh the risks shown in the study.  Vorpaxar will be used for the treatment of reducing the risk of stroke in those patients who have a history of myocardial infarction or heart attack. In this type of event the heart is blocked long enough for a part of the heart muscle to become damaged or die. Having an MI increases the chances of a patient having a stroke. Vorpaxar is not recommended for those who already have a history of stroke prior to having a heart attack.

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