News of considerable importance to patient safety

  • Clinical trials of hydroxychloroquine are stopped temporarily

    | 27 May 2020 |

    Five clinical trials in Denmark testing the efficacy of hydroxychloroquine on COVID-19 are discontinued until further notice. This takes place after a major international study has indicated that there is no beneficial effect of using the product; in contrast, there could be serious adverse reactions.

  • EMA clarifies use of chloroquine and hydroxychloroquine for COVID-19

    | 02 April 2020 |

    Chloroquine and hydroxychloroquine must only be used for COVID-19 in clinical trials or national emergency use programmes in COVID-19 patients whose condition is critical, says the European Medicines Agency, EMA.

  • Risk of supply failure: Use protective equipment rationally

    | 22 March 2020 |

    There is a risk that the healthcare sector will run out of protective equipment, such as hand sanitizer, facemasks and visors/shields, which are crucial in the fight against coronavirus. We urge everyone to use at little as possible without compromising on safety.

  • Restriction on sale of medicines in pharmacies (clarification)

    | 19 March 2020 |

    The Minister of Health has activated parts of the drug preparedness. This means that you cannot buy more prescription medicines at the pharmacy than what you normally use, and that the amount of OTC medicines being dispensed has been limited. The decision has been taken to avoid hoarding.

  • Withdrawal of vaginal mesh

    | 03 May 2019 |

    Three types of vaginal mesh for surgical treatment of pelvic organ prolapse have been withdrawn in the USA after the FDA has assessed that the evidence of the products' efficacy and safety is insufficient. As a result, the products will no longer be available in Denmark.

  • Vaginal mesh from Bard removed from the EU markets

    | 12 March 2019 |

    The company Bard has decided to stop the sale of vaginal mesh implants on the markets in the EU. The decision is based on commercial reasons according to Bard.

  • DKMA Update December 2018

    | 23 January 2019 |

    In this issue of DKMA Update you can read about safety for medical devices; new biosimilar medicines for Humira; better conditions for clinical trials in Denmark; new front page for our website and much more

  • New report on adverse reactions reported with tramadol for pain relief

    | 20 December 2018 |

    The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.

  • Three research projects to increase our knowledge of medicinal cannabis

    | 01 November 2018 |

    Three projects have just been granted funds to give us more knowledge about the efficacy of medicinal cannabis. A total of DKK 5 million have been distributed of the funds that were appropriated by the negotiating parliamentary parties under the special funds agreement 2018-2021 to accumulate scientific knowledge of medicinal cannabis.

  • Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

    | 30 October 2018 |

    There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

  • Safer prescription of blood thinning agents

    | 04 September 2018 |

    A collaboration between pharmaceutical companies, pharmacies and authorities has eliminated a common cause of dosing errors involving blood thinning agents.

  • DKMA Update June 2018

    | 03 July 2018 |

    In this issue of DKMA Update you can read about new rules on private individuals' import of medicines, Danish Medicines Agency being key driver in European solution for complex clinical trials and much more.

  • DKMA Update March 2018

    | 28 March 2018 |

    In this issue of DKMA Update you can read about evidence; changes to Tramadol’s summary of product characteristics; inspections of the sale of OTC medicines outside pharmacies and much more

  • Be aware of rare but possible risk of liver injury in medical treatment of fibroids

    | 15 February 2018 |

    The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.

  • Danish Medicines Agency to send safety information directly to healthcare professionals

    When side effects or the like is discovered for medicines, the medicine’s product information sometimes needs to be changed to the point that healthcare professionals must be informed directly. Up to

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