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Do not dismiss Relvar Ellipta based on theoretical concerns

Although the promotion of medicines safety should be applauded, I disagree with the concerns of Tony Capstick and colleagues (PJ, 22 February 2014, p199) because they do not appear to be evidence based. Although comparative potencies of corticosteroids is an important issue, this lies in the theoretical realm. If randomised controlled trials assessing patient-oriented outcomes have shown the product to fall into the category of a low-to-mid-dose inhaled corticosteroid then this should over-ride any theoretical concerns, at least until there is sufficient post-marketing experience to prove otherwise.

My fear is that the authors will actually have caused confusion over Relvar Ellipta’s place in therapy, potentially promoting its off-licence use as a high-dose corticosteroid. This would inevitably skew post-marketing data collection and adverse event reporting against that which would be expected under the licence.

In the interest of transparency, I should make clear that I was employed by the manufacturer of Relvar Ellipta during its development. That was some years ago and I am now working far from the pharmaceutical industry as a clinical pharmacist, so I do not feel this is consciously affecting my opinion.

What certainly affects my opinion is the involvement of the European Medicines Agency as a result of the authors’ concerns. My estimation of the EMA has suffered in recent months following some baffling restrictions to medicines announced on the back of theoretical concerns and limited evidence, such as the broad five-day course restrictions applied to metoclopramide based on the risk of extrapyramidal effects. This came despite years of experience and safe use, coupled with the complete failure to recognise the concern this would cause in palliative care where prolonged courses are entirely justified.

Another example is the contraindication of codeine in paediatrics and breastfeeding mothers, again despite years of experience and safe use in the vast majority of patients and with little consideration of the impact. Now these patients are largely, and unavoidably, being exposed to more potent and “dirtier” opioids, such as tramadol, or to non-steroidal anti-inflammatory drugs, which carry their own unique variety of risks.

We are left with the potential for Relvar Ellipta to be restricted in a similarly inappropriate way based on theoretical concerns before we even know for sure how it would perform under the current evidence-based licence. I would have expected the first once-daily combination inhaler to have been welcomed with open arms considering the terrible compliance suffered with inhaled therapies.

The European Medicines Agency responds: The EMA takes seriously its obligation to monitor the safety and efficacy of medicines in the EU and ensure that the benefit-risk balance remains positive in light of continuing experience and constantly accumulating evidence. During all referral procedures the EMA examines a broad range of evidence, both published and unpublished, including from clinical trials, epidemiological studies and spontaneous reported suspected adverse drug reactions from doctors, pharmacists and patients, concerning the safety and efficacy of the medicine in question. This evidence is scrutinised by experts in the agency’s scientific decision-making bodies, and is used as the basis for any scientific recommendation. For key benefit risk evaluations, input from patients may also be sought.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11138178

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