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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

 

Review to evaluate cardiovascular risk with high doses taken over long periods

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels).

The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken at lower doses and for short periods of time.

There is therefore no suggestion of a similar cardiovascular risk with ibuprofen as used by the overwhelming majority of patients. Ibuprofen is one of the most widely used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses.

More information is provided in the following hyperlink:

European Medicines Agency starts review of ibuprofen medicines

 

The Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review at its April meeting.

PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system

The PRAC has advised that the combined use of medicines of different classes acting on the renin-angiotensin (RAS) system, a hormone system that controls blood pressure and the volume of fluids in the body, should not be recommended. The affected medicines (called RAS-acting agents) are used particularly in the treatment of hypertension (high blood pressure) and congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body).

The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) which will adopt the Agency’s final opinion.

More information is provided in the following hyperlink:

Renin-angiotensin-system (RAS)-acting agents

 
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