Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 October 2018

News 05/10/2018

At its monthly meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded a referral and confirmed its advice in the context of a safety signal evaluation. More information on all safety referrals currently under evaluation is provided in the table below.

PRAC recommends restrictions on use of fluoroquinolone and quinolone antibiotics

Following a review of disabling and potentially long-lasting but very rare side effects reported with fluoroquinolone and quinolone antibiotics, the PRAC has recommended that they should only be used to treat infections when an antibiotic is essential and other antibiotics cannot be used. Some medicines from this class of antibiotics will be removed from the market because they were only authorised for infections that should no longer be treated with these medicines.

The review incorporated the input of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018. The public hearing allowed the PRAC to hear directly from members of the public about their views on the risks associated with these antibiotics and to explore further measures that could ensure these medicines are used as safely as possible.

More information is provided below.

PRAC confirms precautionary advice on HIV medicine dolutegravir

The PRAC confirmed its precautionary advice  issued earlier this year on the use of dolutegravir in pregnant women and women who can become pregnant. Women who can become pregnant should use effective contraception while taking dolutegravir. In addition, women should undergo pregnancy testing before starting treatment and the medicine should not be used during the first trimester of pregnancy unless there is no alternative.

The evaluation assessed preliminary results from a study which found cases of neural tube defects (birth defects of the brain and spinal cord) in babies born to mothers who used dolutegravir during pregnancy. As the study is still ongoing, a further assessment will be carried out once the final results become available next year.

Ongoing referrals





Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC adopted a list of outstanding issues to be addressed by marketing-authorisation holders.

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