Muscle mess
Sometimes you can tell when the FDA maybe doesn’t have a whole lot of enthusiasm about getting out a new, very serious warning — especially when it concerns the biggest selling class of prescription drugs on the market.
Last spring, the FDA first warned that the highest dose of Zocor (a statin drug) may increase the risk of muscle damage.
Now, more than a FULL YEAR later, the agency has finally gotten around to telling Merck (the maker of Zocor) to change the drug’s label to show that the 80 mg/day dose raises risk of muscle damage which could be severe enough to completely shut down kidney function.
Here’s another word for zero kidney function: death.
Now I know the FDA says it’s very busy and underfunded. But statins are the most popular drug class in the U.S. Millions of people take them every day. The fact that it took more than a YEAR to get around to such an important warning is borderline criminal! But even worse is the fact that the FDA hasn’t required this warning for ALL statins.
As the Lipitor website has told us for at least three years: “Lipitor can cause serious muscle problems that can lead to kidney problems, including kidney failure.”
Of course, muscle damage and kidney failure are just two of the very serious health risks that get bumped up when taking statin drugs. Other known risks include liver damage, type 2 diabetes, cataracts, and memory loss.
Imagine if a dietary supplement was linked to such a wide range of serious health problems. Angry mobs with pitchforks and torches would be storming FDA headquarters!
But we haven’t heard much at all about those side effects in any of the recent media coverage of the FDA’s “new” warning about Zocor.
And there’s one additional risk linked to Zocor that emerged a couple of years ago, but now you rarely see it mentioned anywhere. And it’s a truly shocking risk that puts all those others in the backseat.
Seriously, it’s hard to believe…
Three years ago I told you about a trial that compared Zocor to Vytorin in more than 700 subjects with high cholesterol.
In theory, Vytorin should be a cholesterol-lowering Big Kahuna, because it combines Zocor and Zetia, a drug that blocks absorption of dietary cholesterol.
Results of the trial showed that both drugs reduced LDL cholesterol, but there was no “significant difference in changes in intima–media thickness” (that is, in the thickness of artery walls) in the Zocor group compared to the Vytorin group.
That’s odd, right? When LDL goes down, it’s supposed to REDUCE thickness of artery walls by reducing plaque buildup. But that quote above, from the conclusion of the study, makes it sound like the reduction was not significant in either group.
But digging deeper into the study you’ll find this note: “There was a slight increase in the mean intima–media thickness over time in both groups.”
Yes, you read that right: an INCREASE in artery wall thickness.
At this point, the FDA took an unusual action. They stepped in to review the study. And about one year later (apparently everything takes a year with these guys) they gave us the lowdown: LDL dropped by more than 50 percent in the Vytorin group and nearly 40 percent in the Zocor group. BUT carotid artery thickness increased in both groups.
And the report adds: “The thickness of the carotid arteries…is a marker of risk for cardiovascular disease.”
So without coming straight out and saying it, they’re suggesting that the use of BOTH drugs in the trial increased cardiovascular disease risk even though LDL cholesterol was significantly lowered.
It’s astounding! But not as astounding as the FDA’s conclusion to the report: “Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications.”
ONLY the FDA could come to such an insane conclusion!
But wait — the insanity continues…
The report notes that results of a previous study led the Zocor/Vytorin researchers to anticipate two things: 1) that LDL would be lowered, and 2) that Zocor would increase artery wall thickness.
So this was the SECOND major study to link Zocor use with narrowed arteries.
At this point it’s pretty pointless to ask the obvious, but it has to be asked: Should you risk muscle damage, kidney failure, liver dysfunction, and memory loss to take a drug that may lower your LDL but may also narrow your arteries?
Imagine how the FDA would answer that — then do the exact opposite.
Sources:
“Zocor (simvastatin): Label Change – New Restrictions, Contraindications, and Dose Limitations” FDA MedWatch, 6/9/11, fda.gov
“Follow-Up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin, Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor), Food and Drug Administration, January 2009, fda.gov
“Simvastatin With or Without Ezetimibe in Familial Hypercholesterolemia” The New England Journal of Medicine, Published online ahead of print, 3/30/08, content.nejm.org
