Regulatory in brief | switches, paracetamol, ulipristal

Regulatory in brief | switches, paracetamol, ulipristal

11 September 2020 - Deborah Wilkes

A parliamentary group in the UK wants the progestogen-only pill to be made available without a prescription, research claims a link between paracetamol and risk taking, and Europe recommends withdrawing the marketing authorisation for a prescription version of ulipristal acetate.

Call to switch progestogen-only pill

The progestogen-only pill should be made available without a prescription in the UK, according to a report from the All Party Parliamentary Group on Sexual and Reproductive Health.

The group wants to widen access to the progestogen-only pill while maintaining public funding for contraception.

The move would help alleviate pressure on primary care, says the group, noting that research shows one third of contraceptive appointments in general practitioners and almost half in specialist services are to maintain existing contraception.

Paracetamol and risk taking

Using paracetamol can increase risk-taking behaviour, according to a study published in the journal Social Cognitive and Affective Neuroscience.

The research on a dose of 1,000mg paracetamol involved three double-blind, placebo-controlled studies. The researchers said paracetamol increased risk-taking behaviour in all three studies.

“Risk perception and risk taking are judgements and decisions that can affect many aspects of our lives,” commented the researchers, “and this common OTC drug may influence this process, unbeknownst to the millions taking the drug.”

Europe takes action on ulipristal acetate

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of the marketing authorisation for 5mg ulipristal acetate for treating uterine fibroids.

The regulatory agency said a safety review had confirmed that the prescription-only medicine – Gedeon Richter’s Esmya and generics – caused liver injury, including the need for liver transplantation.

The recommendation does not affect single-dose ulipristal acetate emergency contraceptives including HRA Pharma’s ellaOne. The EMA said there was no concern about liver injury with these medicines.

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