Naproxen remains OTC in Germany

Oral medicines containing naproxen should remain available without a prescription in Germany, the country’s Expert Committee for Prescription recommended at a meeting on 17 January.
The committee rejected a move by Germany’s federal institute for drugs and medical devices, BfArM, to reverse switch the non-steroidal anti-inflammatory drug (NSAID) from non-prescription to prescription-only status.

Germany’s medicines manufacturers’ association, the BAH, said it “welcomed greatly” the expert committee’s recommendation, which will now be passed on to the country’s health ministers.

Speaking to OTCbulletin shortly before the expert committee met, a BfArM spokesperson said the agency’s reverse-switch proposal had not been triggered by individual adverse-reaction reports, but by international studies comparing NSAIDs – and naproxen in particular – with cox-2 inhibitors. These studies had used naproxen as the control drug because it had the poorest safety profile of all NSAIDs in relation to gastrointestinal complaints, commented the spokesperson.

According to the umbrella organisation, the US National Institutes of Health, data from the US National Institute on Aging’s Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) “indicated an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen when compared with those on placebo”.

The US Food and Drug Administration (FDA) advised people taking OTC naproxen to stick to the recommended dose and duration of use, and asked manufacturers to include more specific information about cardiovascular and gastrointestinal risks in their product labels.

Nevertheless, the BfArM spokesperson insisted that the evidence that had emerged since Germany’s expert committee recommended naproxen for OTC use in 2001 justified returning the NSAID to prescription-only status. However, the expert committee disagreed and maintained the status quo.