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EMA to restrict use of domperidone and diacerein

Regulator's pharmacovigilance advisors also want insomnia drug zolpidem's labelling tightened up

European regulators have recommended restricting the use of osteoarthritis treatment diacerein and nausea drug domperidone in their latest round of drug safety recommendations.

The Pharmacovigilance Risk Assessment Committee (PRAC) – the European Medicines Agency (EMA) body to assess medicine safety concerns in the EU – also said that the label for insomnia treatment zolpidem should be updated to reflect new data about the drug's effect on a person's mental alertness the morning after use.

The recommendation to restrict use of diacerein is due to a re-examination of trial data, which highlighted the increased risk of severe diarrhoea and liver damage associated with the drug.

As such, medicines containing diacerein are no longer recommended for people aged 65 years and above, while any patient starting treatment should be given half the current recommended dose. Any patient who experiences diarrhoea during treatment should also stop taking the drug.

Companies that currently market diacerein include Pharma 2000 under the name Zondar andTRB under the name Artrodar.

As for domperidone, the PRAC has recommended several changes, including reducing the recommended dose and duration of the treatment. The drug should also only be available for use in the treatment of nausea and vomiting, and no longer for other conditions, such as bloating and heartburn.

This decision is based on the drug's negative effects on the heart, which were assessed after the Belgian medicines agency made its concerns known.

Domperidone has a history of safety concerns and an injectable version of the drug was withdrawn in 1985 because of heart-related side effects.

The PRAC also recommend an update to the label of insomnia treatment zoplidem after reports of impaired driving or road accidents the morning after patients took the medicine.

The drug already contained details that it may cause cause drowsiness and slower reactions the day after treatment, but these should be strengthened to highlight the specific risk of driving and any activity that requires mental alertness.

All the PRAC recommendations will now be sent to the EMA's Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration.

Article by
Thomas Meek

10th March 2014

From: Sales, Regulatory



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