FDA Concerns About Zocor/simvastatin in the 80 mg dose

The Food and Drug Administration (FDA) announced concerns yesterday about the risk of muscle injury specifically around Zocor or generic simvastatin in the 80 mg dose.

Statins have been widely used since the 1980's for reduction of cholesterol and reduction in the occurrence of sudden deaths from cardiac arrest, heart attacks and strokes. Muscle injury is known to be an uncommon side-effect of the statins and is proportional to the potency ("strength") and dosage ("size") of the particular statin.

Simvastatin is the most potent of the generically available statins, and the 80 mg dose is the highest dose made for it.

The FDA is concerned (this link is technically worded) that the risk of muscle injury with 80 mg a day of simvastatin is higher than for comparable doses of other statins. Specifically, they are recommending that doctors not start patients on this dose, or increase patients already on lower doses to this dose.

This concern is based on a recently completed medical study comparing the effects of simvastatin in 20 mg and 80 mg doses with and without supplemental Vitamin B12 and folic acid after heart attack.

One of the findings from this study was that the risk of muscle injury with the 80 mg dose was 0.9%, and 0.02% with the 20 mg dose. Prior to this test, the risk with the 80 mg dose had been reported as 0.53%. Hence, the warning.

Please note that if you already are on simvastatin at 80 mg a day for a year or more and not having side effects (such as persistent muscle or joint pain, or weakness), there is no need of concern.

News announcements suggest switching to other medicines that are as effective as 80 mg of simvastatin. The problem with this is that the only medicines that are equally effective are Lipitor 40 mg and Crestor 20 mg. Neither of these is generic, so they are often much more expensive.

If you would like us to switch you to one of these, let us know. Please check your insurance formulary to see which of these you would prefer so you can let us know which one to switch you to.

Can I split this pill?

We often get asked whether it's okay to split or crush a pill. This might come up because of a need to reduce the dose, or because of difficulty swallowing the pill whole (think sulfa antibiotic or potassium replacement).

Generally, pills that have a score or line imprinted into them are intended by the manufacturer to be safely and easily splittable. Also, pharmacies will put an easily visible sticker on the bottle telling you not to crush or split the medication if this is an issue.

Pill splitting devices are easily and cheaply obtained at supermarkets, drug stores and pharmacies and are much easier to use than using a kitchen knife on the counter-tops!

If it interests you to know why some pills should not be crushed or split, there are a number of reasons (h/t Art Gonzalez, Pharm.D., Marshall Hospital Pharmacy Department):

• Crushing pills meant to dissolve under the tongue (sub-lingual) such as nitroglycerin for chest pain or angina can cause them not to work.
• Extended-release formulations of medicines often are designed to have an outer coating that allows the medicine inside to be slowly absorbed into your bloodstream over a long period of time. Spitting or crushing these can allow 12-24 hours worth of that medicine to get into you in a few hours: this would not be good. Often, these medicines have abbreviations after their names such as CR, LA, SR, XL, XR, CD, etc.
• Crushing or splitting pills with potential to be cancer-causing (carcinogenic) or birth-defect causing (teratogenic) can cause the medicine to be released into the air and can be positively dangerous to patients and their family members. Examples would include chemotherapy pills and hormonal pills.
• Sometimes the pill bottle will be labelled not to crush or split the pills because they are fragile, taste bitter, or might stain your teeth or irritate your throat.
  

Is there a link between cell phone use and cancer (v. 2.0)?

I posted on this topic a few months back, and noted that there was no compelling evidence to suggest that cell phone use was linked to brain cancers. Certainly, the occurrence of the types of brain cancer in question (gliomas and acoustic neuromas) has remained pretty much the same over the last decade or two, even though cell phone use has escalated very rapidly.

The World Health Organization (WHO) announced concerns of a potential risk in heavy cell phone use for developing gliomas and acoustic neuromas.

If you've been looking for a good excuse to stop answering your cell phone or to spend money on hands-free headsets, then now's the time!

However, if you are wondering how safe or unsafe cell phone use may be from the standpoint of brain cancer risk it's worth noting that the WHO's findings are far from conclusive.

• The level of risk is not new compared to earlier studies, and is assigned a level of 2B. This means a possible risk of cancer in humans, but with very limited evidence.
  
• Note that other possible carcinogens in the 2B category include carpentry, coffee and pickles.
• Even if this finding is taken at full face value, we are still talking about an uncommon form of cancer which means that the risk in any individual of developing a brain cancer from using a cell phone regularly is still very low.

To me, this is also interesting as telecom industry studies show that cell phone users are using there phones less for actual voice phone calls and more for texting, email and data transmission such as smart phone apps.

Until I am convinced otherwise I plan to continue to use my cell phone, start off my day with a mug of coffee, and eat pickles or kim-chee when the mood strikes me. However, I will continue to defer carpentry to my wife since she is far better at it than me!