Update on Creon & Ursofalk shortages

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Update on Creon & Ursofalk shortages HCFA TEAM May 14, 2024

Update on Creon & Ursofalk shortages

Following reports we have received from patients with Cystic Fibrosis and parents of patients, regarding shortages of Creon and Ursofalk, which have recently occurred in many pharmacies in the country, we would like to inform you of the following.

Our Association has been closely monitoring the problems with Creon and Ursofalk supplies throughout Greece, which have intensified especially in recent months, when some patients with CF and parents of patients started to report that they are experiencing short-term interruptions in the supply of the drugs. Some patients report that they have had to search in several pharmacies to find the medicines and some that they have not been able to find them in any pharmacy in their area and also near their home area.

This has caused considerable concern and anxiety for patients, as the drugs Creon and Ursofalk are part of the daily treatment of Cystic Fibrosis patients. They are the only drugs that patients who have Cystic Fibrosis or have had a transplant and there are no other alternative or generic medicines that they can take. In particular, Creon is an essential pancreatic enzyme preparation for Cystic Fibrosis, which patients take at every meal to help digest food. Of great concern is the fact that some patients inform us that they are forced to reduce their food intake and restrict their diet due to Creon deficiency, either to modify the dosages of the above mentioned drugs, or to discontinue these drugs altogether, with whatever consequences this may have on their general health condition.

Our Association has informed and is in contact with all the competent bodies at national and European level, EOF, IFT, Ministry of Health, Viatris, Galenica, CF Europe, etc., for the immediate restoration of the shortages, while alternative formulations are being sought to meet the needs of our patients. Following the communications of our Association and the cooperation with the competent bodies, we inform you of the following:

  • In our country, Creon 25.000 distributions have been launched, followed by Creon 10.000 and Ursofalk caps.
  • Ursofalk syrup, imported through the IFT in our country, as we were informed by the IFT, was probably hard to find in the Greek market due to the lack of Ursofalk capsules, as patients taking the capsules turned to the syrup.
  • In order to address the reduced availability of Ursofalk, the FDA is exceptionally introducing the new drug URSODEOXYCHOLIC ACID_CAPS_CAPS_250MG/CAP_BT x 60 with the code 2809206201017 and a retail price of €27.24.
  • On 16/5/2024 the EOF issued a new decision temporarily banning parallel exports and intra-community movement of Creon 25.000, Creon 10.000, Ursofalk caps 250mg. The decision contains additional drugs, but also antibiotics, which are taken by patients with Cystic Fibrosis (e.g. Augmentin, Zithromax, etc.) – see the decision of the European Food Safety Authority with a list of all drugs here
  • The Creon shortages are not only in Greece, but it is a European and global problem, due to the company’s inability to produce the quantities needed to meet global demand for the drug, which is made from pig pancreas. Creon deficiencies occur in many European countries, such as Belgium, Austria, Austria, France, Spain, the Netherlands, Portugal, Italy, Sweden, etc. 

* An announcement on Creon shortages in Europe has been published by CF Europe ( here ). Also tIn April 2024, the European Medicines Agency (EMA) issued a Communication ( here ) with instructions to physicians and patients regarding Creon shortages and the inability of the pharmaceutical company to produce the quantity needed to meet the demand for the drug. The statement said that the production problem is expected to continue until 2026.

Until the issues are resolved, we advise patients experiencing any problem to supply Creon and Ursofalk:

  • to continue to send us reports to the Association’s e-mail  helpline@cysticfibrosis.gr as direct reports are essential for the documentation of the Association’s interventions
  • have access to more pharmacies outside their home area
  • communicate with the online Cystic Fibrosis community on the Association’s private Facebook group “HCFA || Member Communication Group” to share information about pharmacies that have availability of medications,
  • contact their doctor to receive further medical guidance and instructions on taking their medication and diet, and also an alternative prescription of the new Ursodeoxycholic acid caps 250mg, in case they cannot find Ursofalk caps or syrup.

We will inform you in detail about the latest news at the next online coffee break of our Association. The date and time of the meeting will be announced shortly.