Warning of multiple sclerosis drugs

BfArM warns against side effects of the beta-interferon-drugs

08/21/2014

Warning of impending side effects in multiple sclerosis treatment with interferon beta drugs. The Federal Institute for Drugs and Medical Devices (BfArM) has informed in a recent communication in accordance with the European Medicines Agency (EMA) and the marketing authorization holders about possible risks in the treatment of multiple sclerosis drugs from the category of interferon beta drugs. According to the BfArM, the beta-interferons can at worst lead to a potentially fatal thrombotic microangiopathy or a nephrotic syndrome.

The „safety-related information“ BfArM addresses all health professionals on the risks of multiple sclerosis drugs. According to the notification of the Federal Institute „Cases of thrombotic microangiopathy (TMA), including fatal cases, have been reported during the treatment of multiple sclerosis (MS) with interferon beta drugs.“ Most of these TMA cases manifested as thrombotic thrombocytopenic purpura or hemolytic uremic syndrome (HUS). These are specific diseases of the small blood vessels, especially in the kidneys and brain. For example, HUS and related kidney damage also included potential complications of EHEC infection in the 2011 epidemic.

Threatening lethal kidney disease?
Another possible side effect of MS drugs is the development of a nephrotic syndrome, in which the kidney bodies are damaged and kidney function is impaired overall. Both TMA and the nephrotic syndrome can, according to the BfArM „several weeks to several years after the start of treatment with interferon beta.“ In the communication of the Federal Institute, doctors and healthcare professionals are therefore called upon to pay particular attention to whether these diseases develop. The clinical picture of TMA is characterized by thrombocytopenia (deficiency of platelets), recurrence of hypertension (hypertension), fever, impaired renal function and symptoms of the central nervous system such as confusion or paralysis, reports the BfArM Should MS patients develop TMA Immediate treatment with plasma exchange may be required and immediate discontinuation of interferon beta is recommended.

Check kidney function regularly
Due to the risk of a nephrotic syndrome, the BfArM advises to regularly check kidney function in MS treatment with beta interferons and „to early signs or symptoms of nephrotic syndrome, such as Edema, proteinuria and impaired renal function, especially in patients at increased risk of kidney disease“, to pay attention. Again, in the case of the disease immediate treatment is essential and the medication with interferon beta should be discontinued if necessary. BfArM names as interferon beta-drugs, which are approved for the treatment of MS in Germany „Avonex® (interferon beta-1a)“ manufactured by Biogen Idec Ltd, „Betaferon® (interferon beta-1b)“ manufactured by Bayer Pharma AG, „Extavia® (interferon beta-1b)“ manufactured by Novartis Europharm Ltd, „Plegridy® (peginterferon beta-1a)“ manufactured by Biogen Idec Ltd and „Rebif® (interferon beta-1a) manufactured by Merck Serono Europe Ltd.

Healing not possible so far
For MS patients, there is no prospect of a cure for the chronic inflammatory disease of the central nervous system. However, inter alia with the help of interferon beta drugs, a significant delay in the course of the disease can be achieved. According to data from the German Multiple Sclerosis Society (DMSG), approximately 2.5 million people worldwide are estimated to be suffering from MS and Germany „According to extrapolations, about 130,000 MS sufferers“ to record. The disease is usually diagnosed between the ages of 20 and 40, although children and adolescents are sometimes affected as well, reports the DMSG. Generally, women tend to suffer significantly more often than men under MS. (Fp)