Friday, December 26, 2008


In the interest of transparency, I must reveal that I have extremely high cholesterol in my blood and a family background of cardiovascular disease. My doctors have all prescribed cholesterol lowering drugs. I have been through every one of them on the market starting with niacin and each time, within three days, I have become a victim of severe muscle aches. That is one of the signs of serious and even fatal side-effects of such drugs.

Recently, while researching material for the updates of my seventh editions of A Consumer’s Dictionary of Food Additives and A Consumer’s Dictionary of Cosmetic Ingredients, I was looking through the FDA’s Medwatch Safety Alerts for Human Medical Products.

I found several describing side-effects from these multi-billion dollar medications in the category. Here they are:

Simvastatin Used With Amiodarone

Audience: Cardiologic healthcare professionals, pharmacists, other healthcare professionals

FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone, (Crodarone®) a medication to keep the heart beating in sync. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

Statin drugs and amyotrophic lateral sclerosis (ALS)

Audience: Neurologists, cardiologists, consumers
[Posted 09/30/2008] An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis was undertaken after the agency received a higher than expected number of reports of ALS patients on statins. It is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with those given a placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

Ezetimibe/Simvastatin (marketed as Vytorin)
Simvastatin (marketed as Zocor)
Ezetimibe (marketed as Zetia)

Audience: Endocrinologists, cardiologists, other healthcare professionals, patients
FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.
FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.

It has been reported recently the incidence of heart disease and stroke have dropped significantly in recent years. Many credit it to the use of cholesterol lowering drugs. Others say, “What about the drop in cigarette smoking, a known culprit in cardiovascular disease? Could that be responsible for the good news and not the drugs?

There have been many negative cholesterol drug reports popping up periodically without much fanfare. For example, with the multi-billion dollar powerful drug Crestor was reported to be “ significantly more likely than other statins to cause muscle deterioration that can lead to kidney disease and failure” according to a study in the American Heart Association's journal, Circulation.

Documents on the FDA website reveal that pharmaceutical companies Merck and Schering-Plough conducted numerous safety studies on the popular cholesterol drug Zetia but did not publish the results, which suggested that the drug may cause liver damage when mixed with statins.

Zetia is a trade name for the drug, ezetimibe, also marketed under the names Ezetrol and Ezemibe. It is a major seller for Merck and Schering, and is estimated to have earned them $5 billion in 2007.

The website http:// explained the Zetia blocks cholesterol absorption in the gut, and is often prescribed in conjunction with another class of cholesterol drugs, called statins. Because statins function in a different fashion by increasing the rate at which LDL cholesterol is cleared from the blood, the combination leads to a greater overall decrease in cholesterol levels. This combination is so popular that Merck and Schering also sell a combination Zetia-Zocor (simvastatin) pill under the brand names Vytorin and Inegy.

But concerns have long existed that the combination of Zetia and statins may lead to liver damage. As early as 2002, an FDA reviewer recommended against allowing the drugs to be mixed, due to liver damage in animal studies. Since the drug's approval, various case studies of liver damage have been published in medical journals.

It may be that the statins are life-safer for the majority of users. But then, again, with the money behind promoting them, they may not be as good as publicity promotes.

Statins currently available in the U.S.include:

* Atorvastatin (Lipitor®)
* Fluvastatin (Lescol®)
* Lovastatin (Mevacor®, Altoprev™)
* Pravastatin (Pravachol®)
* Rosuvastatin Calcium (Crestor®)
* Simvastatin (Zocor®)

To make up your own mind, it might help if you followed the FDA’s as well as some cynical sites such as I, of course, will alert you when I am able, to what is happening backstage.


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