Cholesterol Drug Warning

Posted in Medication at 6:40 AM by Dr. Greathouse



Simvastatin that marketed as Zocor from Merck pharmaceutical company is statin drug to control elevating cholesterol levels.

Million of people has prescribed with this drug without ‘respecting’ to the side effects, both in due to the doses and combination with other drugs.

As growing evidence has linked to this drug with the development of myopathy and rhabdomyolysis, now the U.S. Food and Drug Administration (FDA) just start to warns and recommends for simvastatin use.

Although this decision seem ‘late respond’ as some of previous study has suggested this relationship, however it still useful for remain or candidate patients due to use of simvastatin drug.

The agency recommend to the physicians to limit the use of simvastatin 80 mg and warning in combination with other drugs.

The agency states, “Simvastatin 80 mg should not be started in new patient, including patient already taking lower doses of drugs.”

However, for patients who already taking the drug for 12 months and no indication linking to myopathy, then the drug may prescribed with precautions.

Also, the FDA request to the pharmaceutical company to change drug’s label as above mention including the warning for drug combination with other medications.

This warning and recommendation based on the Study of the Effectiveness of Additional Reductons in Cholesterol and Homocysteine (SEARCH).

Based on SEARCH study results, there were myopathy development in 52 patients taking simvastatin 80 mg and 1 patient taking simvastatin 20 mg.

Also, compared with patients whose taking 20 mg dose of simvastatin, rhabdomyolysis also occurred in patients taking 80 mg dose.

Both of risks at higher rate in the first year, and older people and female are at significant risk.

According to the FDA, the drug should not combined with;
- itraconazole (Sporanox, Jannsen Pharmaceutica),
- ketoconazole (Nizoral from Ortho-McNeil Pharmaceutical),
- posaconazole (Noxafil from Merck),
- erythromycin,
- claritomycin,
- telithromycin (Ketek from Sanofi-Aventis),
- HIV protease inhibitors,
- nefazodone,
- gemfibrozil,
- cyclosporine, and
- danazol.

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