Spain withdraws 29 medicines from circulation amid lab test concerns

SPAIN has withdrawn 29 prescription and over-the-counter drugs from sale after the European Union found testing at the laboratory had breached safety regulations.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In the case of the 29 withdrawn in Spain, alternative medication with the same ingredients can be obtained, says the AEMPS.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).

Within these 11 brand names are anything from two to five variations in terms of pill sizes (such as 10mg or 20mg), number of pills per packet, or capsules versus orally-soluble versions, bringing the total list to 29.

Anyone who still has these medicines at home and is taking them can continue to do so safely, says the health ministry, but once they run out they will be prescribed a different type containing the same active ingredients.

In total, 1,000 drugs were inspected at GVK Biosciences, and 700 were found to have been tested in unreliable circumstances, meaning the EU has ordered their withdrawal from circulation as a precaution until further examination of them can be carried out.