EMA says rules on phthalates in medicines will not block essential treatments
In response to questions posed by Boehringer Ingelheim concerning draft guidance on the use of phthalates as excipients in human medicines
German pharmaceutical manufacturer Boehringer Ingelheim has called for and received reassurance from the European Medicines Agency (EMA) that planned controls on the use of certain phthalates in pharmaceuticals will not lead to swift bans of products.
Boehringer Ingelheim was commenting on draft EMA guidance on the use of phthalates as excipients in human medicines. The firm asked where phthalates exceed EMA’s planned limits and reformulations are not possible, would EMA insist on voluntary withdrawals of products, a phase-out of supplies, and could label updates alone be required?
In reply during formal consultation, EMA said the presence of phthalates DBP or DEP at unacceptable levels could be accepted on a case-by-case basis, depending on the importance of the medicine in treatment terms: 'For instance, in severe or terminal disease conditions' the 'strict application is not considered necessary' where the reproductive and developmental toxicity risks posed by these plasticisers 'is outweighed by the benefits of treatment for patients'.
EMA added that clinical evidence of health problems caused by phthalates was still insufficient to insist that labels declare their presence in capsules. And the Agency said it would give pharmaceutical companies three years to change formulations to meet the new guidance after it comes into force.
