EMA Recommends Restrictions on Multiple Sclerosis Medicine

July 10, 2017

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

The European Medicines Agency (EMA) announced on July 7, 2017 that its Pharmacovigilance Risk Assessment Committee (PRAC) had concluded two referrals and issued provisional measures for the treatment of multiple sclerosis. The committee is provisionally restricting the use of Zinbryta (daclizumab) “to patients with highly active relapsing disease that failed to respond to certain other treatments, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.” EMA stated in a press release that the drug should not be given to patients with liver injury and doctors should closely monitor liver function in patients taking the drug.

PRAC recommended that injectable methylprednisolone medicines containing lactose must not be used by patients with an allergy to the proteins in cow’s milk. The committee also recommended that cow’s milk proteins be removed from the preparation of injectable methylprednisolone. Injectable methylprednisolone is used to treat the symptoms of severe allergic reaction.

At the meeting, PRAC confirmed its restrictions on the use of linear gadolinium agents.

The committee previously determined that there is evidence of gadolinium deposition in brain tissues following use of gadolinium contrast agents.

Source: EMA