News and Educations

PRAC News – April 2014


The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review and started four new safety reviews at its meeting in April 2014.

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

The PRAC has advised that the combined use of two 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 EMA’s final opinion.

Start of review of ambroxol and bromhexine

The PRAC 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 or to increase lung maturation before birth.

This review follows concerns about allergic reactions and severe skin adverse reactions with ambroxol. Since bromhexine gets mainly converted into ambroxol in the body, and there are some reports linking the use of bromhexine with allergic reactions, the review also covers medicines containing bromhexine.

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

The Committee has also begun a review of codeine-containing medicines when used for cough and cold in children. This follows a previous review of these medicines when used for pain relief in children, which was triggered by concerns over the risk of morphine toxicity.

Review of oral methadone medicines containing povidone started

The PRAC initiated a review of oral methadone medicines that also contains 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. The review was started following a number of reports of kidney failure in former or current drug abusers which may be linked to the misuse of methadone oral solutions containing certain types of povidone which might have been injected into vein.

As part of this procedure, the PRAC is inviting stakeholders such as healthcare professionals, patients’ organisations and the general public to submit data relevant to the procedure so that they can be considered during the assessment of the medicines. This tool allows the Committee to actively engage stakeholders in the evaluation process, and helps to ensure that all relevant data, information and knowledge are fed into the assessment

Review of testosterone-containing medicines started

The PRAC has started a review of testosterone-containing medicines over concerns about side effects on the heart. These medicines are mainly used in men who do not produce enough testosterone (a condition known as hypogonadism).

Here you may view more about the PRAC recommendations from the April 2014 Meeting.