EU medicines watchdog the European Medicines Agency (EMA) called for the suspension of “a number of nationally approved medicines”, including Brown and Burk’s tramadol/paracetamol tablets and duloxetine and pregabalin products from Lupin, last month (July 22).
The World Health Organisation found “several issues” with studies into the drugs carried out at bio-pharmaceutical service provider Semler’s research centre in India, the EMA reported.
These included concerns about the “substitution and manipulation” of clinical samples at the facility, and “serious concerns” about "data integrity". A full list of affected drugs can be found here.
But the Medicines and Healthcare Products Regulatory Agency (MHRA) told C+D last week (August 2) that it will not be recalling any drugs in the UK, because there is "no evidence" that they are unsafe or ineffective.
Suspension not binding
Despite recommending the drugs be suspended, the EMA acknowledged that some may be of "critical importance", for example due to a lack of alternatives, in a given EU state. It conceded that national authorities – such as the MHRA – could "temporarily postpone the suspension in the interest of patients".
The EMA's decision on the Semlar research will now be sent to the European Commission, who will make a “legally binding” decision on the drugs that will be valid in all EU countries, it added.
The MHRA stressed that patients should continue to take their current medicines, and should speak to their doctor if they have any questions about the drugs they are taking.