The risk of developing myopathy was rare, but US Food and Drug Administration (FDA) asked for new warnings for statins. The myopathy starts with muscle weakness and pain.
Doctors and patients can work together to stay on top of any side effects while taking statins.
"Tell your doctor about all Rx."
Adverse event reports to the FDA for cholesterol medications, known as statins, showed that a small percentage of people developed myopathy while taking statin medications.
People who developed myopathy had muscle pain and weakness they could not explain. Their doctors also found that they had high levels of an enzyme for muscle function, known as creatine kinase.
The myopathy continued even after people stopped taking the medication. This led the FDA to require new safety labeling for these drugs in late October. Developing myopathy while taking a statin use was rare - only 0.2 percent of people in a large, long-term study.
But they thought the risk was severe enough to update the safety info so that doctors and patients can be aware of the signs and symptoms.
The risk of myopathy with statin use was increased when they were combined with some other medications.
Taking certain antifungal drugs, some antibiotics and some drugs for hepatitis C raised the risk of myopathy when taken with a statin drug. Patients need to make sure their doctor is aware of all drugs being taken when the patient is also taking a statin medication.
Patients taking statins also need to report any muscle pain, weakness or tenderness that they cannot explain to their doctor.
The following of drugs have added this new warning:
• Drugs containing lovastatin – Advicor, Altoprev, Mevacor
• Drugs containing simvastatin – Simcor, Vytorin, Zocor
• Caduet (amlodipine besylate; atorvastatin calcium)
• Crestor (rosuvastatin calcium)
• Lescol (fluvastatin sodium)
• Lipitor (atorvastatin calcium)
• Livalo (pitavastatin calcium)
• Pravachol (pravastatin sodium)
The FDA updated labeling for each of these medications was reported October 26 in the FDA database.