The Association of the British Pharmaceutical Industry (ABPI) have issued a statement on the European Medicine Agency’s (EMA) current Pharmacovigilance Risk Assessment Committee (PRAC) referral looking at the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age.
Ahead of Tuesday's (26 September 2017) Public Hearing on valproate, the EMA's first for drug safety, Dr Virginia Acha, The ABPI's Executive Director of Research, Medical and Innovation said:
"Patient safety and welfare is a primary concern for everyone in the pharmaceutical industry and we express our deepest sympathy to those individuals who suffer from malformations or developmental disorders that may be related to their mother's treatment with anti-epileptic medicines.
"For each and every patient, it is absolutely critical that the risks and benefits of medicines are identified, considered and continually monitored. This is certainly the case for patients suffering from epilepsy where despite the availability of several effective treatments, used to help people live active lives, thousands of British patients still have no effective control.
"As we await the outcome of the EMA's ongoing PRAC referral, of which Tuesday's first ever Public Hearing is an important component, patients and their doctors should continue to refer to the MHRA's excellent toolkit and guidance that ensures everyone is better informed about the risks of taking valproate medicines during pregnancy. Anyone who is worried should speak to their healthcare professional."
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The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. We represent companies who supply more than 80 per cent of all branded medicines used by the NHS and who are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome disease.
Globally our industry is researching and developing more than 7,000 new medicines.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including the pricing scheme for medicines in the UK.