Regulatory in brief | NSAIDs, codeine, CMDh

Regulatory in brief | NSAIDs, codeine, CMDh

22 October 2020 - Deborah Wilkes

The US Food and Drug Administration (FDA) has implemented labelling changes for non-steroidal anti-inflammatory drugs (NSAIDs), New Zealand has confirmed the date for reverse-switching all medicines containing codeine from non-prescription to prescription status, and Europe's Coordination Group for Mutual Recognition and Decentralised Procedures for Humans (CMDh) has a new chair.

US requires labelling changes for NSAIDs

The US FDA has warned in a Drug Safety Communication that taking NSAIDs in the second half of pregnancy can lead to complications.

The FDA has implemented labelling changes for both prescription and OTC NSAIDs but noted they did not apply to low-dose aspirin products.

The regulatory agency said new labelling would explain that if “women take the medication around 20 weeks or later in their pregnancy, the drugs can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid and the potential for pregnancy-related complications”.

The warning follows a review of the medical literature and cases reported to the FDA.

New Zealand confirms codeine date

New Zealand has confirmed the date for reverse-switching all medicines containing codeine from non-prescription to prescription status.

The move – which was recommended by the country’s Medicines Classification Committee (MCC) in 2019 (click here to read the News story) – will be implemented on 5 November 2020.

New chair of Europe’s CMDh

The next chair of Europe's CMDh will be Kora Doorduyn-van der Stoep of the Netherlands.

She has worked at the Medicines Evaluation Board (MEB) in the Netherlands for more than 30 years, and has been vice chair of the CMDh since December 2018.

She will take over from Spain’s Laura Oliveira Santamaria in November 2020 for a three-year term.

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