FDA Advice about Statin Drug Dangers

In early 2013, the Food and Drug Administration updated their health advisories on the safety of statin drugs.  Statin drugs are commonly prescribed to millions of Americans to help lower their cholesterol. 

The FDA deputy director for safety in the Division of Metabolism and Endocrinology Products, Dr. Amy G. Egan, assures patients that statins have been clearly shown to prevent heart disease.  However, she also wants people to be aware that they need to educate themselves about potential side effects so they can let their doctor know if they experience any strange symptoms.

With that thought in mind, here are the FDA advisories:

Liver Injury

The good news is that liver injury is so rare that doctors have been told they no longer need to routinely monitor liver enzymes.  In fact, this monitoring has never been shown to be effective at preventing or predicting serious liver damage.

On the other hand, everyone should be aware of the symptoms of liver damage.  If you experience these symptoms, you will want to notify your doctor as soon as possible so liver enzyme tests can be performed at that time.  The symptoms to watch for are: unusual fatigue, discomfort in the upper right abdomen, loss of appetite, dark colored urine, and yellowing of either the skin or the whites of the eyes.

Memory Loss or Fogginess

Some patients have reported unfocused or fuzzy thinking.  The good news is that these symptoms are reversible once patients stop taking the statin drugs.  However, the FDA recommends that no one should stop taking their statin medications without first talking to their doctor.  The risk to their hearts may be too serious.

Diabetes Risk

Some people have experienced a small increase in their blood sugar levels and the development of Type 2 diabetes after taking statin drugs.  However, the FDA also feels that this small risk is outweighed by the benefits of statins.

Muscle Damage

One well documented risk associated with statin use is myopathy, or muscle injury.  This is characterized by unexplained muscle weakness or pain.  This is more common when patients are taking lovastatin (for example, Mevacor), especially in combination with other drugs.  Once example of this is Advicor which is lovastatin combined with extended-release niacin.  If you experience unexplained muscle pain or weakness, notify your doctor as soon as possible.

Resource Information

Whether you take statin drugs or other prescription medications, you may want to subscribe to FDA updates.   Check out the FDA website at http://www.fda.gov/ConsumerUpdates.

If you want additional health information that is geared specifically to Baby Boomers, you may also be interested in reading:

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New FDA Advice About Statin Risks

 

Statin drugs have been shown to be quite effective in lowering cholesterol levels. However, like nearly all drugs, there are some potential side effects that many people only vaguely know about.

Recently, the Food and Drug Administration issued new guidelines about statin risks, and I felt it was important to let our readers know about these risks so they could watch for any symptoms.  Below are the new guidelines from the FDA.

Good News About Statins

First, the good news.  It is no longer necessary for your doctor to routinely monitor your liver enzymes.  Serious liver injury from statin use is considered very rare.

Statins have been shown to be one of the most effective ways we have to lower cholesterol levels.

Potential Risks While Taking Statins

Memory loss, forgetfulness and confusion have been reported by some statin users.  Researchers have said that, when this occurs, they have found that the confusion can be reversed within weeks after stopping the statin. This may be the result of getting cholesterol levels too low. The brain needs a certain amount of cholesterol in order to function properly. Make sure your doctor is not over-zealous about lowering your cholesterol to the point where it affects your thinking.

Some people on statins have experienced an increase in blood sugar levels, which can lead to Type 2 diabetes.  The number of people who experience this increased risk appears to be small.  However, it is good to be aware of the possibility.

Some medications interact with lovastatin and can increase the risk of muscle damage.  (Since I take lovastatin, I was particularly interested in this potential health risk.)  The new labels for lovastatin are going to list what drugs to avoid taking with lovastatin, and the maximum dose of lovastatin you should take if these other medications cannot be avoided.  Since these drugs were not listed in the FDA article that I read, everyone who is on lovastatin needs to read the insert on their next prescription refill very carefully.

Sore muscles are another possible side effect of statin use.  My doctor suggested that I take 200 mg. of CoQ10 with my statin every day in order to minimize the muscle problem. I have been using this combo for three years and the combination seems to be working.

If you are looking for more heath and retirement information of important to Baby Boomers and retirees, use the tabs or pull down menu at the top of this page.  They contain links to hundreds of additional articles.

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Information about statin risks from the government website at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm?source=govdelivery