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SIDE EFFECTS

FURTHER RESTRICTIONS ON THE USE OF THE MULTIPLE SCLEROSIS DRUG DACLIZUMAB (ZINBRYTA)

The risk assessment of daclizumab (ZINBRYTA) in relapsing multiple sclerosis (MS) which took place as a result of a fatal liver damage (a-t 2017; 48: 64) confirmed according to the European Medicines Agency (EMA) the unpredictable and potentially fatal immune-mediated liver toxicity of the drug. This toxicity can be expected for up to six months after discontinuation of the substance. Serious liver damage occurred in 1.7% of users in clinical trials. The EMA intends to leave daclizumab on the market, but is limiting the approved indication still further: Daclizumab may now only be prescribed if at least two disease modifying MS drugs were insufficiently effective and no others can be used (1). The antibody was initially authorised without restrictions, but since July 2017 its use was limited to patients with insufficient efficacy of at least one disease modifying drug (a-t 2017; 48: 72). Patients now have to confirm in writing before treatment that the risk has been explained to them and that they have understood the significance of the close monitoring (liver function tests at least once a month up to six months after discontinuation) and watching for symptoms of liver damage (1).

Following a request by a-t, the Paul-Ehrlich-Institute confirmed that the patient from Germany who died following acute liver failure resulting in the current risk assessment procedure* was treated as part of an observational study (2, 3) for which the participating doctors received a fee of EUR 1,320 (!) per patient (4). Uncontrolled observational studies of this type have a low scientific value, in this case: "evaluating treatment persistence" (3), and often have the purpose to establish expensive new drugs on the market (a-t 2017; 48: 17-8) ("seeding trial" (5)).

1EMA: press release dated 27 Oct 2017; http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2017/10/WC500237824.pdf
2Paul-Ehrlich-Institut: letter dated 2 Aug 2017
3Paul-Ehrlich-Institut: Datenbank Anwendungsbeobachtungen [database of observational studies]: NIS-No. 380; http://www.pei.de/SharedDocs/awb/nis-0301-0400/0380.html
4Kassenärztliche Bundesvereinigung: letter dated 17 Aug 2017
5ALEXANDER, G.C.: Arch. Intern. Med. 2011; 171: 1107-8
* Despite the procedure that has just been completed, EMA was not able to respond before our editional deadline to a query regarding whether the four suspected reports of fatal liver damage in patients being treated with ZINBRYTA already listed in the database are double or new reports.

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