UPDATE: FDA Changes to Statin Label Could Have a Detrimental Impact on Quest Diagnostics (DGX)
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Up)Dividend Yield: 2.3%
Revenue Growth %: -1.7%
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(Updated - February 29, 2012 6:35 PM EST)
There may be a very important, but overlooked impact from Tuesday's FDA advisory on the popular class of cholesterol-lowering drugs known as statins. The changes could have a negative impact on Quest Diagnostics Incorporated (NYSE: DGX), although shareholders are currently ignoring the news.
In its safety label changes for statins Tuesday, the FDA said the need for routine periodic monitoring of liver enzymes in patients taking statins is no longer needed.
The FDA said, "Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The labels now recommend liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. FDA has concluded serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury."
Statins include top-selling brands like Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
Users of these drugs, in many cases, are getting quarterly blood screening to check liver enzymes among other things.
Routine clinical testing made up 50 percent of the Quest Diagnostics' 2011 revenue. While it is not known what percent is from users of statins, Quest noted blood chemistries including cholesterol levels is a "commonly" ordered tests.
Analysts on Wall Street have yet to weigh in on the expected impact from the statin label change.
A Quest Diagnostics' spokesperson said the company offers approximately 3,000 testing services, and "wholly expects the changes to the statin label to no longer require periodic liver enzyme monitoring to be immaterial to our business."
There may be a very important, but overlooked impact from Tuesday's FDA advisory on the popular class of cholesterol-lowering drugs known as statins. The changes could have a negative impact on Quest Diagnostics Incorporated (NYSE: DGX), although shareholders are currently ignoring the news.
In its safety label changes for statins Tuesday, the FDA said the need for routine periodic monitoring of liver enzymes in patients taking statins is no longer needed.
The FDA said, "Labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. The labels now recommend liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter. FDA has concluded serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury."
Statins include top-selling brands like Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
Users of these drugs, in many cases, are getting quarterly blood screening to check liver enzymes among other things.
Routine clinical testing made up 50 percent of the Quest Diagnostics' 2011 revenue. While it is not known what percent is from users of statins, Quest noted blood chemistries including cholesterol levels is a "commonly" ordered tests.
Analysts on Wall Street have yet to weigh in on the expected impact from the statin label change.
A Quest Diagnostics' spokesperson said the company offers approximately 3,000 testing services, and "wholly expects the changes to the statin label to no longer require periodic liver enzyme monitoring to be immaterial to our business."
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