Drug Safety Alert: IPC flags adverse reactions linked to Dimethyl Fumarate, Cefazolin
New Delhi: The Indian Pharmacopoeia Commission (IPC) has recently issued a drug safety alert for the month of September, revealing that Dimethyl Fumarate is linked to adverse drug reaction alopecia and Cefazolin, a cephalosporin antibiotic, is associated with Acute Generalized Exanthematous Pustulosis.
This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Dimethyl fumarate is a medication used to treat patients with the relapsing-remitting form of multiple sclerosis. Dimethyl fumarate belongs to the class of drugs known as Nrf2 activators. It acts by reducing inflammation and preventing nerve damage.
It is thought to involve dimethyl fumarate degradation to its active metabolite, monomethyl fumarate (MMF). Then MMF up-regulates the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway that is activated in response to oxidative stress.
As per a recently issued drug safety alert, Dimethyl fumarate is associated with Alopecia, a condition in which hair is lost from some or all areas of the body.
In addition to this, the drug safety alert list also includes Cefazolin, which is a beta-lactam antibiotic and a first-generation cephalosporin with bactericidal activity.
Cefazolin binds to and inactivates penicillin-binding proteins (PBP) located on the inner membrane of the bacterial cell wall. Inactivation of PBPs interferes with the cross-linkage of peptidoglycan chains necessary for bacterial cell wall strength and rigidity. This results in the weakening of the bacterial cell wall and causes cell lysis.
Cefazolin is indicated in the treatment of serious infections due to susceptible organisms: respiratory tract infections, urinary tract infections, skin & skin structure infections, billiary tract infections, and septicaemia.
Following the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database, it is reported that cefazolin is associated with the adverse reaction, Acute Generalized Exanthematous Pustulosis.
Acute generalised exanthematous pustulosis is a severe cutaneous adverse reaction characterised by the rapid development of nonfollicular, sterile pustules on an erythematous base.
As per the issued drug safety alert, the following suspected drugs are associated with the ADRs as given below:
Sl. No. | Suspected Drugs | Indication | Adverse Drug Reactions |
1. | Dimethyl Fumarate | For Relapsing remitting multiple sclerosis | Alopecia |
2. | Cefazolin | Cephalosporin antibiotic-indicated in the treatment of serious infections due to susceptible organisms – respiratory tract infections, urinary tract infections, skin & skin structure infection, billiary tract infections, septicaemia | Acute Generalised Exanthematous Pustulosis |
In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADRs associated with the use of above suspected drugs.
Further, the safety alert added, "If such reactions are encountered, please report to the NCC-PvPI, IPC by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPI Helpline No. 1800-180-3024 (Toll Free)."
To view the official document, click on the link below:
