Spain withdraws 29 medicines from circulation amid lab test concerns
Wednesday, January 28, 2015 @ 1:19 PM
SPAIN has withdrawn 29 prescription and over-the-counter drugs from sale after the European Union found testing at the laboratory had breached safety regulations.
The Spanish Agency for Medication and Healthcare Products (AEMPS), part of the ministry of health, says an inspection at the premises of GVK Biosciences in Hyderabad, India, showed that ECG (electro-cardiogram) results had been 'doctored' during tests for 'bio-equivalence'.
Bio-equivalence means checking that the generic, unbranded format of each medication is identical to the branded version.
Given that the 'doctored' ECGs were carried out for some time, the European Union says it cannot vouch for the reliability of the tests carried out at the firm's laboratory.
This said, there is no evidence as yet that any of the medicines in question have any harmful effects on humans.
Where no possible substitute for a given medication is available, these will remain on the market until further information comes to light.
In the case of the 29 withdrawn in Spain, alternative medication with the same ingredients can be obtained, says the AEMPS.
They include anti-vomiting medication (Metoclopramida); anti-histamines (Desloratadina and Ebastina Brown); drugs for treating high blood pressure (Valsartán and Irbesartán), post-menopausal osteoporosis (Alendronic Acid), migraines (Rizatriptan), dementia or Alzheimer's (Donepezilo) and stomach acid reflux (Esomeprazol); anti-depressants (Escitalopram), and diabetes medication (Repaglinida).
Read more at thinkSPAIN.com