Medicinal Products

Dear Healthcare Professional Letter on the shortage of the medicinal product Pedea and information about an alternative treatment


Orphan Europe, the marketing authorisation holder for the medicinal product Pedea 5 mg/ml solution for injection (ibuprofen), has in collaboration with the Agency for Medicinal Products and Medical devices (HALMED) sent a letter to healthcare professionals on the interruption in the supply of the European market with this medicine. this is due to visible particles forming in the vials after production which has been detected only in bathes that have not been released on the market . It is estimated that the shortage will last by the end of 2013. This letter give further information to healthcare professionals about an alternative medicinal product unlicensed in the EU, but imported from the United States in agreement with HALMED and other competent authorities. The letter gives also advice to healthcare professionals regarding precautions to be used when prescribing the alternative unlicensed product in the EU for the indication concerned.

Detailed information on the interruption in supply

Pedea is a medicinal product for rare and severe diseases, so-called "orphan medicinal product” authorised in the EU via centralised procedure on the 29 July 2004 intended to treat haemodinamically significant Patent Ductus Arteriosus in premature newborn infants of less tha 34 weeks of gestational age.

Orphan Europe has recently become aware of a forthcoming shortage in product supply. This is due to visible particles forming in the vials shortly after production. The issue has been detected prior to the release of these batches on the market. So far, it is established that Pedea batches currently on the market are not affected by this manufacturing issue. Nevertheless. healthcare professionals are advised to visually inspect the ampoules for particulate matter and the integrity prior to use.

Since no other medicinal product authorised for the same indication exists in the EU, it is of utmost importance to ensure availability of an alternative product.

Alternative treatment (Neoprofen)

The medicinal product Neoprofen was approved in the US by the Food and Drug Administration (FDA) in 2006. It is intended to treat the closure of a clinically significant Patent Ductus Arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

Neoprofen has been marketed in the US since 2012 by Recordati Rare Disease (before by Lundbeck). Recordati Rare Disease and Orphan Europe are collaborating to resolve the serious and urgent situation to provide the alternative treatment in the EU for the duration of the Pedea shortage.

Neoprofen is an intra-venous formulation of ibuprofen and is in many respects similar to Pedea. However, some differences exist and they are described in details in the letter. The American equivalent of the Summary of Product Characteristics for Neoprofen is attached to the letter.

Here you may see the Dear Healthcare Professional Letter (in Croatian).

HALMED has not received any quality defect or adverse reaction report rearding associated with the use of the medicinal product Pedea. HALMED will continue monitoring the safe use of Pedea and will promptly inform the public about any new information.

We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.