Zocor, 13 Other Drugs, Make FDA List of Medications of Concern
Federal drug safety regulators have released their quarterly list of medications they are monitoring based on adverse event reports received during the second quarter of 2010. Included on the list are 14 medications, including the popular cholesterol drug Zocor, which has been linked to a serious and potentially life-threatening muscle disease known as rhabdomyolysis.
Several times a year, the FDA releases a list of drugs identified by the agency’s adverse events reporting system as showing potential signs of serious risks. The list is generated by the frequency and types of adverse event reports the FDA receives from doctors and patients. Being on the list does not mean that a drug has been shown to have that risk, only that the FDA has received a number of reports that has raised concerns.
From April through June of 2010, the FDA identified potential signals for serious risk associated with Cleocin, Multaq, Implanon, Afinitor, Uloric, Feraheme, Androgen Deprivation Therapy, Fosrenol, Zocor, Invirase, Nucynta, Heceptin, omeprazole products and tetracycline products.
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Learn MoreThe FDA previously initiated a safety review on three of the medications, including Zocor. The other two drugs that were already under review are Invirase, an HIV drug which may disrupt electrical activity in the heart; and Androgen Deprivation Therapy, which is a class of prostate cancer drugs known as GnRH agonists that could increase the risk of diabetes and cardiovascular disease such as heart attack, cardiac arrest and sudden death.
In March, the FDA warned that Zocor users had an increased risk of rhabdomyolysis when taking the drug at high doses of 80 mg. While all statins carry some risk of the muscle injury, the FDA’s report was the first time a dose-specific connection had been made to a particular drug. Symptoms of rhabdomyolysis from Zocor could include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.
Zocor (simvastatin) is a synthetic statin developed by Merck & Co., which is now available as a generic. Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best selling cholesterol lowering drug in the world, bringing in $4.3 billion in 2005.
Invirase (saquinavir) is an antiretroviral medication manufactured by Genentech, which is a subsidiary or Roche AG. The drug was first approved in 1995. It is often used in combination with Abbott Laboratories’ Norvir (ritonavir), another antiretroviral drug approved by FDA in 1996.
In February, the FDA reported that when Invirase and Norvir are used together they could increase the risk of heart abnormalities leading to irregular heart rhythms. The abnormal heart rhythms, a condition called torsades de pointes, can cause fainting, lightheadedness and could leave to life-threatening irregular heart beats.
The safety review of GnRH Agonists was launched in May. The drugs lower male hormones, which can cause prostate tumors to shrink and can slow the progress of prostate cancer. The drugs are sold under the brand names Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard and Synarel. The FDA became concerned after six different studies showed a small increase in the risk of diabetes and cardiovascular disease.
The complete list of medications and potential signals of serious risks identified can be found on the FDA website.
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5 Comments
dianeJanuary 16, 2012 at 6:52 am
I am a widow today, having lost a wonderful husband of 40 years. He was very healthy until one Friday he got a call from doctor saying he needed to come in after feeling sick l week prior. He passed away the following Thursday with what the doctors say was an agressive liver cancer. He had all the tests done before (colonoscopy, tb test, physical and was declared healthy in May only to die on S[Show More]I am a widow today, having lost a wonderful husband of 40 years. He was very healthy until one Friday he got a call from doctor saying he needed to come in after feeling sick l week prior. He passed away the following Thursday with what the doctors say was an agressive liver cancer. He had all the tests done before (colonoscopy, tb test, physical and was declared healthy in May only to die on September 8, 2011. He has been taking simvastatin and complained to his doctor of muscle problems, doctor brushed this off and said to continue taking med. I'm lost without him and I want to know if the simvastatin had anything to do with his loss. Can anyone help me?
kariMay 24, 2011 at 6:16 am
my sister was taking this drug and others, and died suddenly april 30,2011. She had just turned 49 yrs old. and this has left a pain and hole in my heart. We were only 5 yrs appart in age, and she was my little sis. and i will miss her a lifetime now. I hate all the damn drugs. funny my grandfather lived into his 90s in Italy, never took crap drugs, that they dish out here in US like candy.
KristineNovember 8, 2010 at 1:02 pm
My husband almost died last year due to Zocor. He is an active duty service member and was prescribed Zocor to control his high cholesterol. While I was at work one day, I received a phone call from him (he is stationed in Germany) while he was in ICU! Imagine my reaction! His CK count was over 9,000!! Came close to having renal failure among all the other things that go along with the rhabdomyoly[Show More]My husband almost died last year due to Zocor. He is an active duty service member and was prescribed Zocor to control his high cholesterol. While I was at work one day, I received a phone call from him (he is stationed in Germany) while he was in ICU! Imagine my reaction! His CK count was over 9,000!! Came close to having renal failure among all the other things that go along with the rhabdomyolysis. Thankfully, he came through it. But he still has lingering effects. The doctors told him he would be fine in a month or so. HA! Problem is, since he is in the service, he can't do anything. So I am going to TRY to do something on his behalf.
PaulaOctober 30, 2010 at 5:04 pm
I started taking Zocor in January 2010. This month I had a liver panel screen and my enzyme level is 4 times what it was in January! Has anyone else experienced similar results?
MURLIESeptember 26, 2010 at 7:58 am
I was on Lipitor for several years. Then in Nov. 2009 I began to have excruciating pain all over my body. Ended up in the hopital with CKs in the thousands. Hospitalized for 1 week. Came home on high doses of steroids. Went back to work in a month, still in alot of pain. Went off the steroids. Now..several months later, I am still in extreme muscle pain in arms, thighs, neck, back...wherever there[Show More]I was on Lipitor for several years. Then in Nov. 2009 I began to have excruciating pain all over my body. Ended up in the hopital with CKs in the thousands. Hospitalized for 1 week. Came home on high doses of steroids. Went back to work in a month, still in alot of pain. Went off the steroids. Now..several months later, I am still in extreme muscle pain in arms, thighs, neck, back...wherever there are muscles. The muscle biospsy showed dead nerve fibers. Can't hardly do anything but work, then go home and sleep. My life is in shambles. And I am extremely depressed. I could get a lawyer....but what about my life?