The media is a buzz with the news that the FDA is changing the warnings on statins.
The New York Times claims "Safety Alerts Cite Cholesterol Drugs’ Side Effects."
According to the Wall Street Journal "FDA Warns on Statin Drugs."
And the text on the bottom of the CNN report states "FDA places warning on statin labels."
Statins, which are cholesterol lowering medications are now one of the most commonly prescribed medications in the US. If I were one of the millions of patients taking a statin, I would be pretty worried based on what I am hearing from the media.
Fear Not! There is Nothing to Worry About. Do Not Stop Your Statins!
Before getting in the details, it is important to note:
1. It is pretty irresponsible of the media to use scary headlines, when the warnings from the FDA weren't really that bad. In addition, the warnings about liver problems (the one you hear about in all those TV commercials) were actually downgraded.
2. It is not entirely the media's fault. The FDA does a very poor job when releasing information. When they update something, they should make it clear to physicians and patients what the real risk is. Once again, the FDA failed miserably.
3. Statins are probably some of the safest medications we have. If patients could easily perform and interpret their own blood work, these might even be over the counter. Some have suggested that this might be a good idea. Moreover, statins reduce heart attacks and strokes (#1 and #4 killer in the US). Though no medication is perfectly safe, I can think of no other long term medication where the risk benefit ratio is so far in favor of the drug. Cardiologist put this best in his post (via KevinMD) "Let's close the chapter on statin safety."
Ok, now for the details.
Today the FDA released information that they were updating warning information on statins. Essentially, there are three areas where safety data was updated: liver enzymes, memory impairment and diabetes.
Liver enzymes- This one is actually good news. Earlier statins caused some elevations in liver enzymes which were feared to potentially cause liver damage. After many years of usage, it doesn't seem this fear is warranted. Because they can affect the liver, patients with pre-existing liver disease should use statins cautiously. Even though statins can cause liver enzyme elevation, it is usually at the highest doses and usually returns to normal when the statin is stopped of the dosage is lowered. The routine monitoring of liver enzymes that was once recommended is now no longer required.
Memory Loss- This is the one that makes me the most annoyed. First, because it really isn't true and second because the way the FDA communicated the data is useless at best and harmful at worst, since patients may stop taking statins because they are afraid that they will get Alzheimer's.
According to the release the
"FDA reviewed the AERS database, the published medical literature (case reports and observational studies),4-13 and randomized clinical trials to evaluate the effect of statins on cognition.14-17"
The numbers above refer to references of studies they looked at. However, of the 13 studies they analyzed "did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline." In fact, most of these studies were looking at use of statins to PREVENT Alzheimer's. Thus, most of the data they used to make this recommendation was from their own AERS database. It would have been really nice to release this data! However, one of the mentioned publications did look at MedWatch drug surveillance system of the Food and Drug Administration (FDA) from November 1997–February 2002 for reports of statin-associated memory loss. Of course we don't know the exact number of patients that took a statin during those 5 years, but it was in the millions. The authors were only able to find 60 reports, of which none was truly confirmed (just patient report) and more than half noted improvement when the statin was stopped.
I have previously blogged about this issue back in 2008 in my post Lipitor and Memory Loss as well as another post Lipitor: Responding to Spacedoc. Spacedoc is really Dr. Duane Graveline, MD, MPH, a family physician who became a NASA's scientist, but is better known for his book "Lipitor, Thief of Memory" which he wrote after having two episodes of something called transient global amnesia (TGA) which he states was associated with his use of Lipitor from 1999 - 2000. In fact, I actually became aware of TGA because the mother of a close friend had the exact same thing.
Bottom Line- There may be some connection between Lipitor and memory loss. However, even if there is, it is extremely rare (you have a better chance of winning the lottery) and even if you get it, it usually goes away if you stop the medication. In other words, there is absolutely no reason to be alarmed, and no reason not to take the drug if you need it to control your cholesterol.
Diabetes- This is another topic that I have blogged about, and one that seems not to want to go away. You can see my post "Statins Don't Cause Diabetes" for all the details. Much of the concern came from a Crestor trial which actually showed Crestor to cut heart attack risk in half in patients that had relatively normal cholesterol. This study used a particularly high dose of Crestor, and the FDA warnings point to other studies using high dose statins with similar findings. It is important to note that in the Crestor study, about 40% of the patients were at risk for developing diabetes in the first place, that measures of diabetes in the study were really no different, but the physician reported (i.e. unconfirmed) rates of diabetes were increased. However, more importantly, if you look at the actual rates of developing diabetes it was 3% in the Crestor group an 2.4% in the placebo group. In other words, if statins increase your risk of developing diabetes, it increases it only by 6/10 of a percent (not as low a winning the lottery/memory loss, but pretty darn low). However, with millions taking a statin, even a small risk is something to consider. However, one must also note that diabetes is a disease process more than just an isolated sugar number, and it is unclear what actual risk a statin would cause by turning a pre-diabetic patient into a diabetic one. In fact, patients who are pre-diabetic have a 4 to 6 times greater risk of heart attacks and strokes, and statins have been used in pre-diabetic patients and shown to reduce their risk of heart attack and strokes. Conversely, no study has shown that reducing sugar in a diabetic reduces their risk of heart attack and stroke.
Bottom Line-statins may raise your sugar a tiny bit, and for those patients who are at risk for developing diabetes, taking a high dose statin may "push" that patient into having diabetes sooner than expected. However, even in that circumstance, the statin is probably still well worth the risk since it is potentially preventing a heart attack or stroke and slightly increasing the sugar probably has no clinical ramifications.