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Drug Safety Update

From:
Medicines and Healthcare products Regulatory Agency
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  • Tibolone: benefit-risk balance

    Increased risk of stroke in older women should be taken into account in prescribing decisions.

    • Therapeutic area: Endocrinology, diabetology and metabolism and 1 others
    • Published:
  • Simvastatin: increased risk of myopathy at high dose (80 mg)

    There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80-mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who h…

    • Therapeutic area: Cardiovascular disease and lipidology
    • Published:
  • Simvastatin: dose limitations with concomitant amlodipine or diltiazem

    The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.

    • Therapeutic area: Cardiovascular disease and lipidology and 1 others
    • Published:
  • Statins: risk of hyperglycaemia and diabetes

    Statin use may be associated with a level of hyperglycaemia in some patients where formal diabetes care is appropriate.

    • Therapeutic area: Cardiovascular disease and lipidology
    • Published:
  • Statins: benefits and risks

    Statins (HMG-CoA reductase inhibitors) are widely used medicines for patients with lipid disorders and in the primary and secondary prevention of heart attack and stroke.

    • Therapeutic area: Cardiovascular disease and lipidology
    • Published:
  • N-acetylcysteine: risk of false-low biochemistry test results due to interference with Siemens assays

    N-acetylcysteine may interfere with assays from Siemens ADVIA Chemistry and Dimension/Dimension Vista instruments, leading to false-low biochemistry test results.

    • Published:
  • Tredaptive (combined niacin-laropiprant): no longer for prescribing

    Preliminary HPS2-THRIVE trial failed to show benefit outweighs risks

    • Therapeutic area: Cardiovascular disease and lipidology
    • Published:
  • Statins: very infrequent reports of myasthenia gravis

    Globally, there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis with atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin (singl…

    • Therapeutic area: Cardiovascular disease and lipidology
    • Published: