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Review confirms small increased cardiovascular risk with daily doses at or above 2,400 mg

European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day).

The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

More information is provided in the following hyperlink:

PRAC recommends updating advice on use of high-dose ibuprofen

The PRAC has completed a review of the benefits and risks of Iclusig (ponatinib), a medicine used for the treatment of leukaemia (cancer of the white blood cells). The aim of this review was to examine the risk of blood clots or blockage of the arteries or veins and to assess whether further measures were needed to minimise this risk.

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The PRAC has completed an EU-wide review of bromocriptine-containing medicines for preventing or suppressing lactation (breast milk production) in women after childbirth.

Because an association of such treatment with rare but potentially serious (including fatal) cardiovascular, neurological and psychiatric side effects cannot be ruled out, the PRAC has recommended that the medicines only be used for this purpose when there are compelling medical reasons for stopping lactation, such as to avoid further distress after loss of the baby during or just after childbirth, or in mothers with HIV infection, who should not breastfeed. Bromocriptine should not be used routinely for preventing or stopping milk production, nor to relieve symptoms of pain or swelling of the breasts after childbirth.

The Committee also concluded that bromocriptine must not be used in women at increased risk of serious side effects, including women with disorders that increase blood pressure or severe psychiatric disorders.

More information is available in the hyperlink below.

Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum

At its May meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of factor VIII medicines to evaluate the risk of developing inhibitors in patients with haemophilia A who have not previously been treated with these medicines.

Factor VIII is needed for blood to clot normally and is lacking in patients with haemophilia A. Factor VIII products replace the missing factor VIII and help control bleeding. However the body may develop inhibitors as a reaction to these medicines, particularly in patients starting treatment for the first time. This can block the effect of these medicines, so bleeding is no longer controlled.

The review was started following publication of a study which concluded that inhibitors develop more frequently in patients receiving recombinant factor VIII medicines than in those receiving plasma-derived factor VIII medicines. The PRAC concluded that there is no clear and consistent evidence of a difference in inhibitor development between the two classes of factor VIII medicines.

More information is available below:

PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines

EMA reviews diabetes medicine canagliflozin

Review follows data on toe amputations in ongoing study

The European Medicines Agency (EMA) has started a review of the diabetes medicine canagliflozin after an increase in amputations, mostly affecting toes, was observed in an ongoing clinical trial called CANVAS. Cases of lower limb amputation occurred in both the canagliflozin and placebo groups in the trial and the possibility that canagliflozin increases lower limb amputations is currently not confirmed. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from the company to assess whether canagliflozin causes an increase in lower limb amputations and whether any changes are needed in the way this medicine is used in the EU.

More information on this is included in the hyperlink below:

EMA reviews diabetes medicine canagliflozin

Medicinal products without prescription in the Republic of Bulgaria to date 28.02.2011

The present list do not include medicinal products with expired authorization, although in the country they can be sold until exhaustion of the actual quantities, but not more than one year from the expiration date of the marketing authorization (in accordance with Art. 55, Para. (6) of LMPHM).

In the event of a favorable opinion on the marketing authorization renewal procedure, they are going to be added to the list.

Drugs without prescription

On ascertainment of inaccuracies and omissions please call: +359 2 890 34 11 +359 2 890 34 11

Last update of the list 20.03.2017.

EMA’s safety committee (PRAC) is recommending measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines.

A review by the PRAC found that handling errors resulted in some patients receiving insufficient amounts of their medicine. The errors reported included incorrect use of the needle or syringe, causing the medicine to leak from the syringe, and failure to inject leuprorelin properly.

The Committee is therefore recommending that only healthcare professionals familiar with the preparation steps for leuprorelin depot medicines should prepare and administer the medicines to patients. Patients should not prepare or inject these medicines themselves.

The Committee also made recommendations for particular leuprorelin depot medicines.

For more information:

Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors

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