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Drug Safety Update

From:
Medicines and Healthcare products Regulatory Agency
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  • Pneumovax II: tolerability of re-vaccination

    Healthcare professionals should advise patients who need re-vaccination with Pneumovax II to expect a more intense reaction than after their first vaccination.

    • Therapeutic area: Immunology and vaccination and 1 others
    • Published:
  • Ketoprofen and ketorolac: gastrointestinal risk

    Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.

    • Therapeutic area: Pain management and palliation and 1 others
    • Published:
  • Lorazepam: reduction of recommended maximum daily dose

    Maximum dose of lorazepam for short term, symptomatic treatment is 4 mg per day for severe, disabling anxiety, and 2 mg per day for severe, disabling insomnia

    • Therapeutic area: Psychiatry
    • Published:
  • Pabrinex: allergic reactions

    Rare occurrence of serious allergic reactions should not preclude use of parenteral thiamine in patients who need treatment by this route of administration.

    • Therapeutic area: Nutrition and dietetics and 1 others
    • Published:
  • 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:
  • Duloxetine: marketed as Cymbalta▼ and Yentreve▼ for different disorders

    Patients should be assessed regularly due to reported cases of suicidal ideation and suicidal behaviour during treatment with duloxetine or shortly after stopping treatment.

    • Therapeutic area: Endocrinology, diabetology and metabolism and 2 others
    • Published:
  • Corticosteroids: early psychiatric side-effects

    Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.

    • Therapeutic area: Anaesthesia and intensive care and 9 others
    • Published:
  • Desmopressin nasal spray: removal of nocturnal enuresis indication

    Nasal formulations of desmopressin are no longer indicated for primary nocturnal enuresis.

    • Therapeutic area: Endocrinology, diabetology and metabolism
    • Published:
  • Hormone-replacement therapy: updated advice

    Before prescribing hormone-replacement therapy, healthcare professionals should consider carefully the potential benefits and risks for every woman

    • Therapeutic area: Endocrinology, diabetology and metabolism and 1 others
    • Published:
  • α-1 adrenoreceptor antagonists: intraoperative floppy iris syndrome (IFIS)

    Cataract surgeons should check past or current use of α-1 adrenoreceptor antagonists for prostatic hypertrophy before surgery.

    • Therapeutic area: Urology and nephrology
    • Published:
  • Linezolid: restricted indication

    Linezolid is not active against infections caused by Gram-negative pathogens, and treatment should be started only after specialist microbiological advice.

    • Therapeutic area: Infectious disease
    • Published:
  • Dopamine agonists: pathological gambling, increased libido, and hypersexuality

    Healthcare professionals should warn patients that compulsive behaviour with dopamine agonists may be dose-related.

    • Therapeutic area: Endocrinology, diabetology and metabolism and 1 others
    • Published:
  • Isotretinoin for severe acne: who should prescribe it

    Isotretinoin should only be prescribed by consultant dermatologist-led teams and dispensed only by a hospital pharmacy.

    • Therapeutic area: Dermatology and 1 others
    • Published:
  • Extraneal and products that contain (or are metabolised to) maltose, xylose, or galactose: false blood glucose readings

    Patients who use products that contain maltose, xylose, or galactose should use glucose-specific monitors.

    • Therapeutic area: Endocrinology, diabetology and metabolism and 1 others
    • Published:
  • Aspirin: not licensed for primary prevention of thrombotic vascular disease

    In the UK, low-dose aspirin is licensed for prevention of thrombotic cerebrovascular or cardiovascular disease only in those who already have vascular disease—ie, secondary prevention.

    • Therapeutic area: Cardiovascular disease and lipidology
    • Published: