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PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small.

Update of product information is recommended

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine. This follows concerns over the risk of allergic reactions with these medicines, which are widely used as expectorants (to help clear mucus from the airways).

The PRAC considers that the risk of allergic reactions is small, but has recommended that the product information for these medicines should be updated with further information on severe allergic reactions, and that severe skin reactions (SCARs) should be introduced as a side effect. SCARs include conditions such as erythema multiforme and Stevens-Johnson syndrome.

More information on this is included in the hyperlink below:

PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small

 

Start of review of codeine-containing medicines when used for cough and cold in children

PRAC recommends restricting use of codeine when used for pain relief in children

The PRAC has recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.

More information on this is included in the hyperlink below:

Codeine-containing medicines

Review of hydroxyzine-containing medicines started

The European Medicines Agency has started a review of hydroxyzine-containing medicines, which have been approved in most EU countries for a variety of uses including anxiety disorders, as premedication before surgery, for relief of pruritus (itching), and for sleep disorders.

More information on this is included in the hyperlink below:

Hydroxyzine

Review of testosterone-containing medicines started

The European Medicines Agency has started a review of testosterone-containing medicines, mainly used in men who do not produce enough testosterone (a condition known as hypogonadism).

More information on this is included in the hyperlink below:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Testosterone-containing_medicines …

Review of Corlentor/Procoralan started

The European Medicines Agency has started a review of the medicine Corlentor/Procoralan (ivabradine). Corlentor/Procoralan is used to treat the symptoms of adults with long-term stable angina (chest pain due to obstruction in the arteries in the heart) or long-term heart failure (when the heart cannot pump enough blood to the rest of the body).

More information on this is included in the hyperlink below:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Corlentor_and_Procoralan …

Start of review of ambroxol and bromhexine-containing medicines

The European Medicines Agency has started a review of medicines containing ambroxol and bromhexine, which are widely used as expectorants, as well as to relieve sore throat. Some formulations are used to treat breathing disorders in premature and newborn babies.

More information on this is included in the hyperlink below:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Ambroxol_and_bromhexine-containing_medicines …

Review of oral methadone medicines containing povidone started

The European Medicines Agency has started a review of oral (by mouth) methadone medicines that also contain povidone. Methadone-containing medicines are used in rehabilitation programs in patients dependent on opioids, such as heroin, to prevent or reduce withdrawal symptoms in order to decrease the chance of relapse.

More information on this is included in the hyperlink below:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Methadone_medicinal_products_containing_povidone …

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

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the risks of combining different classes of medicines that act on the renin-angiotensin (RAS) system, a hormone system that controls blood pressure and the volume of fluids in the body.

More information on this is included in the hyperlink below:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Renin-angiotensin_system_%28RAS%29-acting_agents …

CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem

European Commission to take final legal decision

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority new recommendations for zolpidem-containing medicines, used for the short-term treatment of insomnia (difficlty sleeping).

More information on this is included in the hyperlink below:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Zolpidem-containing_medicines …

PRAC recommends restricting use of domperidone

Benefits still considered to outweigh risks when given short-term and in low doses to treat nausea or vomiting.

More information on this is included in the hyperlink below:

http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Domperidone_31/Recommendation_provided …


European Medicines Agency starts review of ibuprofen medicines (23.06.2014)

PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system (24.04.2014)

PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system (24.04.2014)

European Medicines Agency concludes class review of bisphosphonates and atypical fractures

Benefit-risk review of Multaq started

Important safety information regarding Gadolinium - containing contrast agents and risk of Nephrogenic Systemic Fibrosis (only available in Bulgarian)

European Medicines Agency recommends use of fibrates as second-line treatment

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