PRAC feedback to working parties Presented by: V. Hivert, - PowerPoint PPT Presentation

PRAC feedback to working parties Presented by: V. Hivert, R.Anderson (PRAC) 25 September 2019 An agency of the European Union

Pharm acovigilance Risk Assessm ent Com m ittee Representatives from each m em ber states + 6 independent experts + Mem bers representing healthcare Mem bers representing patients' professionals organisations Raymond Anderson Cathalijne van Doorne Pharmaceutical Group of the European European Federation of Neurogical Union (PGEU) Associations (EFNA) Alternate Alternate Roberto Frontini Virginie Hivert European Association of Hospital EURORDIS - Rare Diseases Europe Pharmacists PRAC feedback to working parties, 25 September 2019

Highlight on 4 procedures Under evaluation - Referral on 5-FU and others associated products - Restriction in use of Xeljanz Com pleted procedures - Referral on Quinolones and Fluoroquinolones - Referral on Methotrexate containing medicines PRAC feedback to working parties, 25 September 2019

Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products - Under evaluation Article 3 1 referral (This type of referral is triggered It is known that some patients lack a working enzyme called dihydropyrim idine dehydrogenase when the interest of the Union is involved, following ( DPD) which is needed to break down fluorouracil. concerns relating to the quality, safety or efficacy of a Build-up of high levels of fluorouracil can lead to medicine or a class of medicines.) severe and life-threatening side effects . Patients Centrally and nationally authorised products (mixed) with a complete deficiency of DPD should therefore Start date - 15/ 03/ 2019 not be given fluorouracil, or medicines that can form it in the body. Fluorouracil (given by injection), capecitabine and tegafur are cancer m edicines , whereas topical EMA will assess the available data in relation to (applied to the skin) fluorouracil is used for various existing screening m ethods to detect DPD skin conditions and flucytosine is a medicine used deficiency and recommend whether any changes in severe fungal infections . are needed to the way these medicines are used in order to ensure their safe use. PRAC feedback to working parties, 25 September 2019

Xeljanz (tofacitinib) - under evaluation EMA’s safety committee (PRAC) is recommending Article 2 0 procedure (This type of procedure is that doctors must not prescribe the 10 mg triggered for medicines that have been authorised via twice daily dose of Xeljanz (tofacitinib) in patients the centralised procedure in case of quality, safety who are at high risk of blood clots in the lungs. or efficacy issues.) The new advice means that, since 10 mg is the only Restrictions (temporary) in use of Xeljanz while recommended starting dose for ulcerative colitis, EMA reviews risk of blood clots in lungs patients with this condition who are at high risk of Xeljanz is currently authorised for the treatment of blood clots must not be started on Xeljanz [ … ] or rheum atoid arthritis, psoriatic arthritis and must be sw itched to alternative treatm ents . severe ulcerative colitis . The PRAC will now carry out a review of all An ongoing study in patients with rheumatoid available evidence , and updated guidance will be arthritis showed an increased risk of blood clots in provided to patients and healthcare professionals the lungs and death when the 1 0 m g tw ice daily once the review is concluded. dose was used, which is double the recommended PRAC feedback to working parties, 25 September 2019 dose for rheumatoid arthritis.

Article 31 referral – Quinolones and Fluoroquinolones New restrictions to avoid potentially permanent side effects. Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used: • to treat infections that m ight get better w ithout treatm ent or are not severe (such as throat infections); • to treat non-bacterial infections , e.g. non-bacterial (chronic) prostatitis; • for preventing traveller’s diarrhoea or recurring low er urinary tract infections (urine infections that do not extend beyond the bladder); • to treat m ild or m oderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used. PRAC feedback to working parties, 25 September 2019

Article 31 referral – Methotrexate containing medicines New measures to avoid dosing errors Misunderstandings of the dosing schedule have led to patients taking the medicine daily instead of w eekly , with serious consequences, including fatalities. Additional measures to reduce dosing errors include: • restricting w ho can prescribe these medicines, • making w arnings on the packaging m ore prom inent • providing educational m aterials for patients and healthcare professionals • tablets for weekly use will be provided in blister packs and not in bottles or tubes PRAC feedback to working parties, 25 September 2019