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EMA’s safety committee (PRAC) recommended restricting Lemtrada for use in adults with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage.

The PRAC had issued interim measures on Lemtrada while reviewing reports of serious reactions. The PRAC completed the review and recommended that Lemtrada must no longer be used in in patients with certain heart, circulation or bleeding disorders or in patients who have auto-immune disorders other than multiple sclerosis.

The recommendations reflect PRAC’s review of reports concerning rare but serious effects, including deaths, from immune-mediated conditions (caused by the body’s defence system not working properly) and serious disorders of the heart, circulation and bleeding.

More information is available on the hyperlink below:

Lemtrada for multiple sclerosis: measures to minimise risk of serious side effects

The PRAC concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk.

The PRAC recommended that Xeljanz should be used with caution in patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk unless there is no suitable alternative treatment. Patients older than 65 years of age should be treated with Xeljanz only when there is no other appropriate treatment.

These recommendations follow the PRAC’s review of an ongoing study in patients with rheumatoid arthritis and an increased risk of cardiovascular disease. The study showed an increased risk of blood clots in deep veins and in the lungs with both the 5 mg and 10 mg twice daily doses of Xeljanz as compared with patients taking TNF-inhibitors (medicines that help reduce inflammation).

More information is available on the hyperlink below.

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-31-october-2019

EMA’s safety committee (PRAC) is recommending new measures to avoid dosing errors that have led to some patients incorrectly taking methotrexate-containing medicines daily instead of weekly.

The new measures include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. In addition, to help patients follow the once-weekly dosing, methotrexate tablets for weekly use will be provided in blister packs and not in bottles (or tubes).

Methotrexate is used for treating both inflammatory diseases and cancers. When used for inflammatory diseases, such as arthritis and psoriasis, it is taken once a week but for some types of cancer, a much higher dosage is needed and the medicine is taken more frequently. Mistakes in prescribing or dispensing methotrexate as well as misunderstandings of the dosing schedule have led to patients taking the medicine daily instead of weekly for inflammatory diseases, with serious consequences, including fatalities

Мore information:

https://www.ema.europa.eu/en/medicines/human/referrals/methotrexate-containing-medicinal-products

Regular liver function testing required during treatment

The PRAC has completed its review of Esmya (ulipristal acetate), used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb), following reports of serious liver injury.

After considering all the evidence, the PRAC concluded that the medicine must not be used in women with liver problems and that certain other patients may start new treatment courses provided they have regular liver tests. In addition, PRAC recommended that Esmya should be used for more than one treatment course only in women who are not eligible for surgery.

The PRAC’s recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for the adoption of EMA’s final opinion, and this will then go to the European Commission for a final legal decision. A letter will be sent to doctors to inform them of the new restrictions of use, which will become applicable after a Commission decision is issued.

More information:

PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids

The European Medicines Agency (EMA) has started a review of the risk of dosing errors with methotrexate medicines. When used for inflammatory diseases, such as arthritis and psoriasis, methotrexate is taken once a week whereas for some types of cancer, the dose is higher and the medicine is used more frequently. Mistakes have led to some patients incorrectly receiving a dose every day instead of every week. As a result, patients have received too much of the medicine, with serious consequences in some cases.

More information:

Methotrexate containing medicinal products

The European Medicines Agency (EMA) has recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, due to an increased risk of death and fractures with this combination.

More information:

Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone

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EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of retinoid1 medicines and has recommended updating the measures for pregnancy prevention and including a warning on the possible risk of neuropsychiatric disorders (such as depression, anxiety and mood changes).

During its review, the PRAC assessed the available data including published literature and post-marketing reports of side effects, and also sought the views of patients and healthcare professionals in a dedicated stakeholder meeting and a successive written consultation.

More information

The PRAC recommendations are summarised below:

Retinoid-containing medicinal products

The European Medicines Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC) are recommending new measures to avoid exposure of babies to valproate medicines in the womb. Babies exposed are at risk of malformations and developmental problems.

More information:

PRAC recommends new measures to avoid valproate exposure in pregnancy

No new patients should start treatment for the time being.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation.

As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids.

All women taking Esmya should have a liver function test at least once a month during treatment. If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient. Liver tests should be repeated 2 to 4 weeks after stopping treatment.

The PRAC is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being.

A link between Esmya and cases of serious liver injury is under review. These recommendations are temporary measures to protect patients’ health, pending the conclusion of the review of Esmya which started in December 2017.

More information:

Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing

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