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Laxmi Yadav, Mumbai October 14 , 2021
The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI), has flagged a drug safety alert revealing that dimethyl fumarate which is indicated for relapsing-remitting multiple sclerosis is associated with adverse drug reaction alopecia while cefazolin, a cephalosporin antibiotic is linked with acute generalised exanthematous pustulosis (AGEP).

This came to light after the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database.

Dimethyl fumarate is an anti-inflammatory and immunomodulatory agent that is used to treat relapsing forms of multiple sclerosis. It is not a cure for multiple sclerosis. It helps decrease the number of episodes of worsening multiple sclerosis.

Dimethyl fumarate belongs to the class of medications called Nrf2 activators. It works by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.

Relapsing-remitting multiple sclerosis is the most common form, accounting for about 85 per cent of all multiple sclerosis diagnosism. It is characterized by unpredictable relapses or exacerbations of symptoms or by the appearance of new symptoms followed by periods of remission. During periods of remission, symptoms may improve or even disappear.

As per drug safety alert issued by IPC on September 30, 2021, dimethyl fumarate is associated with alopecia, a medical condition involving the loss of all body hair, including eyebrows.

Besides this, the drug safety alert list also contains cefazolin which is also known as cefazoline and cephazolin.

Cefazolin is a first-generation cephalosporin antibiotic used for the treatment of several bacterial infections. Specifically, it is used to treat cellulitis, urinary tract infections, skin and skin structure infection, pneumonia, endocarditis, joint infection, and biliary tract infections. It is also used to prevent group B streptococcal disease around the time of delivery and before surgery. It is typically given by injection into a muscle or vein.

The preliminary analysis of ADRs from the PvPI database revealed that the antibiotic is linked with acute generalised exanthematous pustulosis, a drug-related severe skin reaction characterized by acute formation of sterile pustules on an erythematous background, fever and neutrophilia.

Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADRs associated with the use of these suspected drugs. If such reactions are encountered, it needs to be reported to the NCC-PvPI for suitable action.

IPC had earlier also flagged drug safety alerts revealing that drugs-- clobazam, baclofen and rosuvastatin and ticagrelor interactions are associated with risks like DRESS syndrome, encephalopathy and rhabdomyolysis respectively.

IPC had earlier also flagged drug safety alerts revealing that drugs-- clobazam, baclofen and rosuvastatin and ticagrelor interactions are associated with risks like DRESS syndrome, encephalopathy and rhabdomyolysis respectively.

It had also flagged safety alerts against etoricoxib, torsemide and quetiapine & valproic acid interaction, sofosbuvir.

The CDSCO had started PvPI in July 2010 across the country. Since then, IPC has been mandated to establish clinical evidence between the drug and the ADR event through a robust system of causality assessment.

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