EMA Begins Publishing All Health Professional Communications

Regulatory NewsRegulatory News | 14 February 2020 |  By 

The European Medicines Agency (EMA) said Friday it’s now publishing all safety communications sent directly to health professionals by marketing authorization holders (MAHs) and competent authorities on its website.
In the EU and European Economic Area, direct health care professional communications (DHPCs) are used to convey important safety information about medicines either by MAHs or competent authorities, such as the suspension or withdrawal of a medicine for safety reasons, a change in product information or a supply shortage.
EMA says it will now publish all DHPCs that are agreed upon by the agency’s Pharmacovigilance Risk Assessment Committee (PRAC), Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), “at the time of national dissemination.”
So far the list of DHPCs at the EU level published by EMA include one for the suspension of Picato (ingenol mebutate) and an advisory for Ecalta (anidulafungin) explaining how solutions for infusion must not be frozen.
The agency’s DHPC website also features links to the DHPC registers for EU and EEA national competent authorities.
PRAC Calls for Restrictions on Cyproterone
Due to the potential risk for meningioma in patients taking medicines containing cyproterone, PRAC is recommending restricting the use of products containing 10mg or more of the drug to treat hirsutism, androgenic alopecia, acne and seborrhea after other treatments have failed.
For patients taking cyproterone at higher doses to treat those conditions, PRAC says the dose should be gradually reduced to the lowest effective dose.
According to PRAC, the incidence of meningioma in patients taking the drug is rare, affecting between 1 and 10 in 10,000 patients, with the risk increasing based on dose and duration.
The committee also says that cyproterone should only be used to lower sex drive in men after exhausting other treatment options.
PRAC says it did not identify a risk for meningioma in patients taking low-dose versions of the drug in combination with ethinylestradiol or estradiol valerate, adding that people who have had a meningioma should not take the drug as a precaution.


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