This Article is About
us food and drug administration
statin drugs
food and drug administration
american adults
type ii diabetes
liver disease
chronic conditions
FDA Makes Stunning Admission About Statins, Will Not Pull Approval, Will Change Labels
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FDA Makes Stunning Admission About Statins, Will Not Pull Approval, Will Change Labels

The US Food and Drug Administration has made what many critics are calling a stunning admission related to the ongoing use of statin drugs to treat high cholesterol. New research has called the safety and efficacy of the drugs into question but the FDA has announced that it will not be changing the approval or prescription recommendations for this medications. Instead, all statin drugs, including the most popular label names, will be given new labeling precautions to be placed on the package inserts for patient education. Critics are calling the move nothing more than an attempt to appease the major pharmaceutical companies instead of protecting the health and welfare of the patients of the country.

The report has come after a comprehensive analysis of a large number of studies related to these drugs. Looking at information for more than 90,000 patients who are currently on a statin drug or have used one in the past, researchers found an increase in a number of serious chronic conditions that could be related to those drugs. Key among them and most concerning to some doctors is the increased risk of continually elevated blood sugar which increases the risk of developing Type II Diabetes. But, there are other potential side effects that need to be clearly spelled out for potential payments as well. The use of statins can also increase the risk of muscle damage and in some patients, liver disease as well. The FDA reported on its own web site that while it might concede that these are high risk drugs it will continue to recommend that most patients continue to take it.

In light of these new warnings, critics are also left wondering why the FDA might be considering that statins be recommended to otherwise healthy people as well.

Statin drugs, including Lipitor, Crestor and Vytorin are big business in the United States, prescribed to more than twenty million American adults every year and bringing in over fourteen billion dollars in one year alone. The FDA is recommending that people continue to take their prescribed medications but to discuss concerns with their doctors. In addition, the agency is also recommending that additional health tests be performed prior to starting a statin and continuing at a regular basis while on the medication. Patients are also urged to discuss whether statins are the best course of action for their own situation or if they could be better served by another type of care.


Street Talk

Excellent article!! I have been told by my Primary to take 10mg of simvastatin but after hearing all the whoopla surrounding it haven't been taking them. Thanks Don

Reply
  about 1 decade ago

It all becomes a balance between the good these drugs do provide versus the symptoms. Well written and certainly gives us more to think about when it comes to prescription drugs used to treat what ails us.

Reply
  about 1 decade ago

Folks need not wonder why the FDA still recommends most patients continue to take these dangerous poisons, it's a $14 + billion dollar annual business, and the FDA is staffed with industry leaders. Thanks for sharing.

Reply
  about 1 decade ago
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