Highlights of October EMA/PRAC meeting

At its monthly meeting, the European Medicines Agency's 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 authorized for infections that should no longer be treated with these medicines.

The review incorporated the input of patients, healthcare professionals and academics presented at the 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 andto explore further measures that could ensure these medicines are used as safely as possible.

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.

Dolutegravir is the active ingredient of Tivicay from ViiV Healthcare, the specialty HIV/AIDS company majority owned by GlaxoSmithKline (LSE: GSK), as well as another HIV combination product Juluca.

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