PHARMACISTS in Spain have withdrawn 18 types of drug at the recommendation of the European Medications Agency (EMA) due to 'untrustworthy' laboratory tests.
The Spanish Healthcare Products and Medications Agency (AEMPS) says the drugs in question do not necessarily pose a health risk and are believed to be effective, and patients should not stop using them without their doctor's recommendation.
GPs will prescribe another type of pill with the same active ingredients instead.
Routine audits on good clinical practice carried out by Austrian and Dutch authorities in June 2012 and February 2016 on the research laboratory which trials the drugs prior to their being retailed – Micro Therapeutic Research Labs, based in India – found a number of incidences where testing did not meet international guidelines.
The results of the trials are therefore considered not to be reliable, and the drugs cannot be approved for distribution within the European Union.
Only six of them are retailed at present in Spain, as others have been discontinued.
Variations of eight different brand names – 18 types of medication in total – have been taken off sale.
The full list features Tadalfil Aurovitas (5mg, 10mg and 20mg) for treating erectile dysfunction and enlarged prostate; Aurobindo (5mg/160mg and 10mg/160mg) for treating allergic rashes; Hidroxizina Qualigen (25mg), a pre-med tranquilliser and anti-psychotic; Bupropion Sandoz (150mg and 300mg), used to treat withdrawal symptoms when giving up smoking; Naproxeno Aurobindo (250mg, 500mg and 1g), an anti-inflammatory pain reliever for fungal infections; Betahistina Bluefish (8mg and 16mg), an antihistamine; Perindopril/Indapamida Combix (2mg/0.625mg, 4mg/1.25mg and 8mg/2.5mg), a diuretic and medication for high blood pressure; and Amlodipino/Valsartan Aurovitas (5mg/160mg and 10/160mg), for high blood pressure and angina.
