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Duration of treatment with atorvastatin is unlikely to increase the risk of muscle-related side effects as most occur within the first year of treatment, after which the risk is not increased further. [64] The known cardiovascular benefits of atorvastatin over time outweigh the low risk of muscle-related side effects. [65] [64]
The most important adverse side effects are muscle problems, an increased risk of diabetes mellitus, and increased liver enzymes in the blood due to liver damage. [ 5 ] [ 66 ] Over 5 years of treatment statins result in 75 cases of diabetes, 7.5 cases of bleeding stroke , and 5 cases of muscle damage per 10,000 people treated. [ 35 ]
It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects. [2] [3] Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns.
Statins are effective and considered safe for most people, but they raise the risk of side effects, including muscle aches, liver problems, mental fuzziness and the potential for developing ...
When examining the cost-effectiveness of statin use in older adults, the researchers report that statins were cost-effective, with the cost per quality-adjusted life years gained below £3,502 ...
This can be life-threatening if not recognised and treated in time, so any unexplained muscle pain or weakness whilst on lovastatin should be promptly mentioned to the prescribing doctor. Other uncommon side effects that should be promptly mentioned to either the prescribing doctor or an emergency medical service include: [10]
In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose Results in death; Is life-threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability/incapacity
Life-threatening, as it used in the drug safety world, specifically refers to an adverse event that places the patient at an immediate risk of death, such as cardiac or respiratory arrest. By this definition, events such as myocardial infarction , which would be hypothetically life-threatening, would not be considered life-threatening unless ...