EU stamps Pfizer’s chewable lipitor for older kids

Statins are cholesterol lowering drugs, which are beneficial for people who are suffering from heart disease.  Statins have been in controversy recently, whether Statins should be prescribed to healthy people.  Well, recent news from Pfizer Inc comes with more surprise for me that Pfizer developed a chewable version of Lipitor for children over age 10 and got approval from European Commision.

Lipitor is the best-selling medicine from Pfizer with annual sales of $11.4 Billion in 2009, worldwide.  Pfizer has developed a chewable form of Lipitor.  The main ingredient in this Lipitor is atorvastatin calcium and is made for children with high levels of LDL cholesterol in the blood. This is not the first medicine for children, as Pfizer quoted that Lipitor has been approved for use in children ages 10 to 17 in the United States since 2002.

We know that obesity is a real problem in children and as per U.S. Centers for Disease Control and Prevention (CDC) rate of child obesity has more than doubled since the mid-1990s to 17% in 2008. Obesity can lead to higher blood pressure and cholesterol in children, but I am not positive of keeping children on prescribed medicine at such a young age.  Mark Sisson quotes in his blog post “the beginning of the end” that there is giving statins to children at young age will avoid heart disease at later life.  But some physicians believe otherwise, in one article in NY...

“Dr. Bhatia said that although there was not “a whole lot” of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children.”  

Lipitor has been blockbuster hit for Pfizer and has brought a lot of revenue.  Lipitor will lose its patent protection for Lipitor next year and will face competition from generics.  Pfizer is planning to apply an additional six months of patent protection available under European Union regulations as an incentive to develop treatments for children.  Is this strategy to sustain in market with exclusivity for some more time?

Medical science has made a lot of advancement and pharmaceutical companies have contributed to it to a great extent.  But, there have been cases of side effects with long term use of medicines and at a young age of 10 – 17 years, are children at risk of long tern side effects.  I think we need some strong studies to back up approval of drugs like statins for children.

Source: SFGate

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