Tuesday, December 28, 2004

This is Very Bad Idea

An article in USA Today reports Merck next month will make its second try for approval to sell cholesterol drug Mevacor without a prescription.
"I think it is a very bad idea," says Brian Strom, a medical doctor and professor at the University of Pennsylvania School of Medicine.
Over-the-counter drugs are meant for short-term conditions that patients can diagnose themselves, he says. "High cholesterol has none of those things."

Mevacor (lovastatin) is one of the "statins." These medications are effective in lowering cholesterol and the risk of coronary artery disease. However, these medications do have potentially serious side effects. They can cause liver damage; liver enzymes should be periodically monitored in patients taking them. The statins can also cause muscle pain and muscle breakdown. In severe cases (rhabdomyolysis), the muscle breakdown can lead to kidney failure. The statins should only be taken under a doctor's supervision.
If Merck suceeds in marketing Mevacor over-the-counter, they deserved to be sued into oblivion for any side effects that consumers suffer from taking this medication. You would think that Merck would be more cautious after the withdrawal of their medication Vioxx.
A bonus tip for any residents reading this: It is well known that combining statins with fibrates increases the risk of liver enzyme elevation and myopathy. Yet this combination is sometimes necessary in patients with combined increased LDL/increased triglycerides. Tricor (fenofibrate) is slightly safer in combination with statins than Lopid (gemfibrozil).

21 comments:

Saint Nate said...

I agree with you and Dr. Strom. Mainstream news stories have hyped statins' potential benefits for many conditions, such as Alzheimer's and cancer prevention, which could lead consumers to take them even if their cholesterol isn't an issue. These drugs simply arent' meant for people in good cardiovascular health, and as such they should only be adimistered under a physician's oversight.

Even though statins have a relatively good adverse effect profile, the recent surge of bad press against the FDA and pharmaceutical companies shows the public is ready to panic if yet another approved drug turns out to be unsafe. Here, we have a drug we know could be deadly if misused - or possibly even when used correctly. It's a very bad idea made horrible by the timing.

I'll bet there are some lawyers reading this story, salivating at the prospect of another class-action payday against Big Pharm.

Dreaming again said...

My uncle, a pharmacist, started taking a statin drug. A few weeks later, he was having weakness and pain, but somehow, didn't associate it with the drug. A few days after the pain started, he recieved a Christmas card from me. My christmas card said nothing imparticular, but because it came from me, it set off alarm bells in my uncle's brain. I have Myasthenia Gravis, the card from me, triggered thinking about my health ..which in turn ..made him think about his weakness and then a light went off in his brain and he called his doc and said he was stopping the statin drug.
This was a PHARMACIST who'd been a pharmacist for over 40 years! And a GOOD one.
How many people would take this drug and have the rare muscle problem and not have a niece with MG that can trigger the necessary train of thought to realize it's harming them?? While the statistics for this complication are rare now, if it goes OTC and people take it without Dr's RX ..would it STAY rare?

Just as a side ... I started to take the statin this last November. Warned, by my neuro, my PCP and my PCP's nurse, and reminded AGAIN in writing when I picked up the sample, that my risk for problems was high. I started taking it a week before Thanksgiving. The next Tuesday, my former PT called me and said "why in the world are you so out of breath?!" He was very alarmed. I hadn't realized I was, and made something up real quick about having had to rush to the phone. I did NOT connect it to the drug. The day after Thanksgiving going to Walmart, I felt like I was walking through jello, a lady asked me about sizing on clothing, and asked me if I had asthma because I was so short of breath. I walked out of the mens department and fell when the carpet changed to tile. I had to have help getting up. That's when I finally realized ... um ...my MG was NOT tolerating the statin drug.
I've had MG for 15 years, dx'd for almost 13. I was a new patient educator for our MG foundation for 3 years. I've also got Lupus and asthma and a whole host of things. I'm experienced and I know my body, I know my disease and I know the risks and I DIDN'T CATCH IT!

Going over the counter with one of these drugs ... they think they're getting sued (growl, shouldn't be happening) now ... they do this, and they will get sued like crazy ... and then, it just may be justified!!

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