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Drug Safety Update

From:
Medicines and Healthcare products Regulatory Agency
  • Illegal herbal remedies containing Aristolochia: vigilance needed

    MHRA continues to identify cases of herbal medicines, particularly traditional Chinese medicines, which contain illegal and toxic Aristolochia or aristolochic acids.

    • Therapeutic area: Pain management and palliation
    • Published:
  • Ecoflac infusion solutions: risk of air embolism

    To avoid the risk of air embolism, these products should not be infused under pressure.

    • Therapeutic area: Anaesthesia and intensive care and 22 others
    • Published:
  • Inhaled corticosteroids: pneumonia

    Physicians should remain vigilant for pneumonia and other infections of the lower respiratory tract (ie, bronchitis) in patients with chronic obstructive pulmonary disease who are treated with inhaled products that contain s…

    • Therapeutic area: Respiratory disease and allergy
    • Published:
  • Botulinum toxin products: rare but serious risks

    Products that contain botulinum toxin are associated with the risk of serious adverse reactions due to distant spread of toxin.

    • Therapeutic area: Neurology and 1 others
    • Published:
  • Piroxicam: new restrictions, including specialist initiation

    Systemic piroxicam should be initiated only by specialists as a second-line treatment for arthritis, with patients who currently take piroxicam reassessed at a routine appointment.

    • Therapeutic area: Pain management and palliation and 1 others
    • Published:
  • 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: