EU Approves Pfizer Cholesterol Drug for children
July 7, 2010 by Levis Taylor · 1 Comment
Pfizer has won approval in the European Union to start marketing a chewable version of their anti-cholesterol drug Lipitor to children as young as 10. Pfizer has already won U.S. approval for Lipitor use in children 10 to 17 with that condition in 2002.
Lipitor is the world’s top-selling drug, with 2009 sales of about $13 billion, but the drugmaker’s biggest problem is that its U.S. patent expires at the end of November 2011. So, it seems, that they will lose most Lipitor revenue in 2011, so Pfizer has been trying to boost sales where possible. A few years ago, cholesterol drugs have been primarily taken by adults with heart disease, but their use has expanded to younger patients too. Lipitor is approved to lower risk of heart attack and stroke, but can cause dangerous muscle pain or weakness.
Reuters also reported that many people in the US are still not being screened for high levels of “bad cholesterol” (LDL), and when they are found to have it, are often never treated. “We found 60 percent of people with high levels of LDL cholesterol didn’t know about these conditions,” said Dr. Elena Kuklina of the U.S. Centers for Disease Control and Prevention.
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Cardiologist Peter Langsjoen notes that statin treatment may lead to heart muscle weakening and failure. ‘It occurs because statin drugs block the production of coenzyme Q10, vital for the production of cell energy,’ says Langsjoen. ‘Evidence to the FDA shows marked reduction of CoQ10 in patients on statin drugs.’
So with children as young as 10 being offered statins another point to be borne in mind is the use of long term drug therapy to lower cholesterol levels, where it is unclear what the full effects might be over a 30 year period. In spite of this, the Food and Drug Administration (FDA) gives approval for this class of drugs on the basis of less than 10 years’ clinical trials.