"The FDA AERS data analyzed in this study, however, suggests that the higher potency of rosuvastatin may more than offset any safety advantages due to such factors," Golomb said. She added that pooled analysis of statin studies in patients with stable heart disease do not indicate that higher strength statins result in a lower death rate. Therefore, "evidence showing that stronger statins may pose a greater risk of side effects is particularly important."
"Post-marketed studies utilizing AERS data are becoming increasingly important to understand the lasting side effect risks of widely used medications in disparate populations. Until recently, conducting such studies has been difficult due to the fractured and inaccessible nature of the FDA's raw data," said Brian Overstreet, CEO of AdverseEvents. The study utilized the company's unique data sourcing method called RxFilter™, which analyzed more than 140,000 AERS case reports filed with FDA over a six-year time period.
Statins are among the most widely taken prescription medications in the world, with over 30 million users in the United States alone and $19 billion in domestic sales. They are prescribed to lower cholesterol, and reduce the risk of cardiovascular disease. Their use has been linked to a variety of muscle-related side effects (together termed "statin myopathy") that occur in as many as 10 to 15 percent of all statin users. These include commonly reported problems such as pain and weakness, as well as life-threatening muscle breakdown, known as rhabdomyolysis. Statin myopathies can significantly increase pain and injury risk and affect mobility, especially in older individuals.
"Only a fraction of adverse effects are reported to the FDA, and a range of factors can influence reporting rates and accuracy of this information," Golomb said. "However, findings from this study align with -- and extend -- other forms of evidence."