Friday, March 19, 2010

Salmon Rises (Again!) -- On Merck's Zocor® "Muscle-Pain-to-Renal-Failure" Continuim

This story comes to us (do go read it all) from the ever-vigilant Salmon, via our comment box, below:

. . . .There's a story in today's Los Angeles Times regarding rhabdomyolysis and renal failure with high doses of Zocor® and higher risk in those of Chinese descent.

This is consistent with what I have been saying here and elsewhere for a long time.

Many lethal drug reactions are due to issues related to drug metabolites or drug metabolism.

Increased risk for some of these reactions can be predicted by knowledge of drug metabolism and in some cases pharmacogenetics.

Knowledge of an individual's pharmacogenetics is not necessary for communicating risk information. Instead knowledge of the individual's ethnic background is often sufficient to indicate a higher probability of risk.

Companies and the FDA have known of this for years (in some cases nearly 20 years) and have been remiss in not including such information in labeling.

Failure to include such information in labeling in my opinion means the drug is misbranded.

-- Salmon

March 19, 2010 @ 2:06 PM. . . .

Indeed. However (post 2008), it is the rather unusual patient who ends up on such a high dose of statins, that this becomes a truly-vexing issue -- excepting of course, where genetic factors (as Salmon mentions) elevate the cholesterol markedly, and ethnic (again, other genetic) factors then magnify the statin-risk presented. All of that said, one-sixth of the planet faces the genetic marker problem, as Merck seeks to expand beyond the US and Western Europe, with Zocor.

For some learned background on just how little we really know about all of this, take a look here.

Good stuff, Salmon!


Anonymous said...

Thank you but this goes to not just statins and not just for drug metabolism.

For example the anticonvulsant/ mood stabilizer carbamazepine (Tegretol - Novartis) can cause Stevens Johnson's Syndrome, which can cause your skin to die and peel off in sheets resulting is a 10% mortality rate.

As a mood stabilizer carbamazepine is often used for bipolar disorder.

In the past few years it has been shown that in certain southern Chinese populations the risk of SJS is extremely high if you have a certain genetic marker. (See

However even without knowing about this genetic marker it was known for years by Novartis that approximately 20% of Taiwanese and 15% of Thai (numbers from memory) (half the population of Bangkok, 5% of pop, is of chinese ethnicity.) may develop SJS if placed on carbamazepine. In fact the incidence was so high that Novartis couldn't really sell any drug in those countries.

So even without this genetic information what stopped Novartis from including this information in the labeling (US and ex-US) for decades(?) when they knew about the increased risk?

I also know of a certain cancer drug that is more likely be less effective and more likely to kill African Americans. However if the information were included in the label I estimate that it might cause the company to lose $400 million in sales per year.

What is stopping this company from including the information in the labeling?


Anonymous said...

"it is the rather unusual patient who ends up on such a high dose of statins" This isn't particularly true over the last couple of years in the US as discounted generics have significantly taken over the market. People who would have been prescribed atorvastatin or rosuvastatin are now often getting simva 80

Anonymous said...

To all who care,
One thing to distinguish is that the warning related to niacin is specific to Merck's extended-release niacin product combined with their who-knows-what-it-actually-does product laropiprant. It does NOT apply to Kos/Abbott's extended-release niacin product Niaspan (also Advicor and Simcor).