The year-long safety review got underway last year after the FDA witnessed a higher- than-expected number of reports of Lou Gehrig's disease in patients being treated with the cholesterol-lowering drugs.
41 long-term studies of patients taking the cholesterol-lowering drugs were analyzed during the one-year safety review.
During the long-term clinical trials, 10 of 56,000 patients in the placebo group were diagnosed with Lou Gehrig's disease, a condition medically known as Amyotrophic Lateral Sclerosis (ALS), compared to 9 out of 64,000 in the statin group.
Statically, "the incidence of ALS among statin-treated patients was 4.2 cases per 100,000 patient years and was 5 cases per 100,000 patient years in placebo-treated patients" the FDA marked.
"The results show no increased incidence of the disease in patients treated with a statin compared with placebo" U.S. health officials averred.
However, though the findings of the study are ‘reassuring’, Dr. Mark Avigan, director of pharmacovigilance in the FDA's drug center maintained, "Given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted."
The FDA analysis was published in the journal Pharmacoepidemiology and Drug Safety.
About Amyotrophic Lateral Sclerosis:
Amyotrophic Lateral Sclerosis, more commonly known as Lou Gehrig's disease in the western part of the world is a progressive neurodegenerative disease.
Caused by the degeneration of motor neurons - the nerve cells in the central nervous system that control voluntary muscle movement – the condition typically results in muscle weakness and atrophy throughout the body.
In severe cases the patient loses complete voluntary control on body movements except for the eyes. The condition is usually fatal.
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