Anticoagulant medicine pradaxa (dabigatran etexilate) - update safety provided by european medicines agency

Anticoagulant medicine pradaxa (dabigatran etexilate) - update safety provided by european medicines agency

Pradaxa, authorized since March 2008 for the primary prevention of venous thromboembolic events in adults who underwent elective total hip replacement surgery or total knee replacement surgery has also been authorized since August 2011, for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Clinical trials have shown that the efficacy of Pradaxa remains unchanged.

The European Medicines Agency (EMA) acknowledges the recent media interest about fatal cases of bleeding in patients treated with Pradaxa.

It is a well-known fact that anticoagulant medicines cause a risk of bleeding, and has been advertised in Pradaxa's EU approved product information since its initial marketing authorization, which states that doctors are recommended to check for signs of bleeding and discontinue treatment in patients with severe bleeding.

Pradaxa has several contraindications, which includes patients who are bleeding and those with severe renal impairment. It should always be used with caution depending on indication and circumstances, and with lower doses for elderly patients and those with moderate renal impairment.

The issue has been closely monitored and in October 2011, the EMA's Committee for Medicinal Products for Human Use (CHMP) suggested further product information changes after learning about reports concerning fatal cases of bleeding in Japan, and after assessing the latest available worldwide data on fatal bleeding risk.

The CHMP's recommended updated product information holds advice in terms of assessing renal function in all patients prior to starting Pradaxa therapy. Whilst on treatment, it also suggests that renal function should be examined at least once a year in patients above the age of 75 years and in patients of all ages whenever a decline in renal function is suspected. The marketing authorization holder has sent out letters with the CHMP's recommendations to inform doctors about the change.

On November 6, 2011 the EudraVigilance database showed data of 256 worldwide spontaneous cases of serious fatal bleedings in association with the use of dabigatran, the active substance of Pradaxa, 21 of these cases occurred in the EU.

The reported number of patients with bleedings who were treated with Pradaxa must be viewed in context to the fast global rise in Pradaxa use due to its new indication approval for stroke prevention and systemic embolism in adult patients with non-valvular atrial fibrillation in several countries across the world. Furthermore, the increasing awareness of the drug results in higher than usual reporting of side effects.

According to the CHMP the recommended changes to the use of Pradaxa will manage the risk of bleeding appropriately. The EMA will continue to monitor this issue very closely together with the overall safety profile of Pradaxa. The Committee will re-examine all case reports that have been received to-date to confirm that there is no increase in the frequency occurrence of fatal bleedings, and that the recommended product information is sufficiently appropriate in terms of risk management.

Patients requiring further information regarding their Pradaxa therapy should seek their doctor's advice. Pradaxa treatment should not be discontinued without medical consultation.

Pradaxa Bleeding Risk Information (Video Medical And Professional 2020).

Section Issues On Medicine: Cardiology