Use of Gynecological Drugs Restricted In EU; ‘Urgent’ Safety Review Starts For Pholcodine

A Review Has Also Started For Topiramate

The European Medicines Agency has completed its investigation into the safety of nomegestrol and chlormadinone, and has started reviewing risks linked to the cough suppressant, pholcodine, and the epilepsy and migraine drug, topiramate.

Wooden blocks with the word Review. Customer review concept. Reviewing, auditing, reviewer. Service rating. Feedback.
Safety reviews are under way for pholcodine and topiramate • Source: Almay

Restrictions are to be placed on the use of drugs containing high doses of nomegestrol or chlormadinone in the EU after the European Medicines Agency concluded that these medicines, which are used to treat gynecological disorders, can increase the risk of meningioma.

In addition, the EMA has started an urgent review of the safety of the cough suppressant, pholcodine, as well as a review of the epilepsy and migraine drug,

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Post-Marketing Regulation & Studies

More from Product Reviews

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By 

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.