News and Educations

News from the PRAC - July 2014


The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety reviews and gave a recommendation as part of a regular benefit-risk assessment review of a medicine at its July meeting.

PRAC issues recommendation for oral methadone products containing povidone

The PRAC has concluded its review of oral (by mouth) methadone products containing the additive povidone. Oral methadone medicines are available as solutions or tablets. The PRAC recommends the suspension from the market of methadone oral solutions containing high molecular weight povidone. In addition, the PRAC recommends changes to the product information for tablets containing low molecular weight povidone to reinforce the message that tablets are for oral administration only and must not be taken in any other way.

Oral methadone medicines are used in rehabilitation programs to prevent or reduce withdrawal symptoms in patients dependent on opioids, such as heroin. When misused by injection, those solutions that contain high molecular weight povidone may cause serious harm.

More information is available here.

PRAC concludes review of Rienso

The PRAC has concluded its regular benefit-risk assessment of Rienso (known as a periodic safety update report or PSUR). Rienso (ferumoxytol) is used to treat anaemia in patients with long-term kidney disease.

As part of this assessment, the PRAC looked at recent reports of serious hypersensitivity reactions with the medicine. The benefits of Rienso continue to outweigh its risks; however, to better manage the risk of hypersensitivity reactions, the Committee recommended, among other measures, that the medicine should be given by infusion over at least 15 minutes (instead of by injection) and that it should be contraindicated in patients with any known history of drug allergy.

PSURs are reports providing an evaluation of the benefit-risk balance of a medicine. They are submitted by marketing-authorisation holders at defined time points following a medicine’s authorisation. During PSUR assessments, the PRAC evaluates any new risks identified for a medicine, to assess whether its balance of benefits and risks has changed. The Committee can then decide whether further investigations need to be carried out or they can recommend action to protect the public from the risks identified.

PRAC recommends restricted use for bromocriptine in inhibiting post-partum lactation

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 here.

Update on the ongoing review of valproate and related substances

To inform its ongoing review of valproate and related substances, the PRAC discussed feedback received during a meeting organised with valproate patients, carers and their families. Valproate medicines are used for treating epilepsy and bipolar disorder and in some countries, migraine. The PRAC initiated a review of these medicines in October 2013 following the publication of new studies which showed a possible risk of long-term problems in development in children born to women treated with valproate.

As part of this review, the PRAC sought to actively involve representatives from patients’ organisations concerned with epilepsy, bipolar disorder and migraine and also organisations representing the patients, families and carers who have been affected by valproate. Consequently, a meeting was organised at the end of June involving various patients' organisations, and representatives from PRAC as well as EMA staff.

This was a very constructive meeting which led to a good exchange of information and allowed a better understanding of the process for the PRAC assessment. Patients were able to share their views, including on how to best raise awareness and inform the patients concerned and their families as well as the relevant healthcare professionals.

This valuable input from patients, carers and their families will be taken forward by the PRAC in reaching its recommendation on valproate and related substances. The PRAC confirmed the importance of continuing to involve patients' organisation as well as healthcare professionals in its review.

More information about the valproate and related substances safety review is available here.

More about the PRAC recommendations from July 2014 is available here.