When to Wait and See

Health Alert 267

Dear Subscriber:

You’ve read about the statin cholesterol drugs. Today I want to warn you of a related threat. A “safer” cholesterol drug, Zetia, has hit the scene. It has rapidly moved onto the list of top-selling drugs. Doctors wrote more than 4.2 million prescriptions for it last year.

It turns out that the only evidence suggesting it was safer came from the drug company selling it. And researchers tested Zetia for only three months before the FDA approved it. That’s not nearly enough time to know if it’s safe.1


* Other Dangers Overlooked *


Here are some of the problems with Zetia:


  • In the clinical trials, almost twice the number of Zetia patients showed abnormally high levels of an enzyme called CPK. CPK levels are high in muscle toxicity and heart attacks.



  • The FDA has reported an elevation of a liver enzyme that signals liver damage.2



  • Two reports in the Annals of Internal Medicine found that Zetia caused muscle and tendon pain.3 This is troubling to me since I believe the best fix for heart disease is progressively strenuous exercise.



  • Within one year of hitting the market, the FDA began receiving multiple reports of adverse reactions including muscle breakdown, increased CPK, elevated liver enzymes, heart problems, liver failure, pancreatitis, gallbladder inflammation, gallstones, and nausea among others.4



  • The FDA approved Zetia even though its own reviewer sounded a warning of serious safety concerns and recommended against approval.5


* Wait for a Track Record *


Since drugs don’t occur in nature, every new drug is an experiment.

With our current system, you may not know about serious adverse effects or life-threatening interactions until large numbers of people take the drug over time. Unfortunately, the real test of safety comes after the drug hits the masses.

Many new drugs

(at least a dozen recently that I’m aware of) are withdrawn or “black box” warnings are added to their labels after their release.6

Use drugs as a last resort. Unless you are dealing with an emergency, you should wait several years after its release before taking any new drug.

To Your Good Health,

Al Sears MD

Sources:

1 Ezetimibe: new preparation. A cholesterol-lowering drug with no clinical advantage; Prescrire Int. 2004 Oct;13(73):176-9.

2 Wolfe, Sydney M. MD; Do Not Use Until-Oct. 2009 Zetia or Vytorin for Cholesterol Lowering; Worst Pills Best Pills News; PCHRG; December 2004

3 Ezetimibe and Statin-Associated Myopathy; Annals of Internal Medicine, April 20, 2004

4-5 Wolfe, Sydney M. MD; Do Not Use Until-Oct. 2009 Zetia or Vytorin for Cholesterol Lowering; Worst Pills Best Pills News; PCHRG; December 2004

6 Health Research Group, www.citizen.org