IPC alerts healthcare professionals about cephalosporins induced fixed drug eruption

Mumbai, March 28, 2022:

The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI), has flagged drug safety alert revealing that beta-lactam antimicrobials, cephalosporins are associated with adverse event known as fixed drug eruption.

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

Cephalosporins are used to manage a wide range of infections from Gram-positive and Gram-negative bacteria.

Since cephalosporins were discovered in 1945 by the Italian pharmacologist Giuseppe Brotzu, they have been used to treat a wide range of bacterial infections due to their high efficiency, broad-spectrum antibacterial activity, low toxicity, and resistance to enzymes.

First-generation cephalosporins are active predominantly against Gram-positive bacteria, such as Staphylococcus and Streptococcus. They are therefore used mostly for skin and soft tissue infections and the prevention of hospital-acquired surgical infections.

Second-generation cephalosporins are more effective against Gram-negative bacterial species that are resistant to the first-generation cephalosporins. They have proven effective against gram-positive Staphylococcus and Streptococcus bacteria, and some Gram-negative bacteria, including Bacteroides fragilis, H. influenzae, Moraxella catarrhalis, N. meningitidis, N. gonorrhoeae, and some Enterobacteriaceae.

Cefamandole, cefonicid, cefuroxime, cefuzonam, cefaclor, cefprozil, cephamycins or 7-methoxycephalosporins, Cefoxitin, cefotetan, and cefmetazole are considered second-generation cephalosporins called cephamycins. Second-generation agents are useful for community-acquired infections of the respiratory tract and uncomplicated urinary tract infections. The cephamycin group is useful for mixed aerobic–anaerobic infections of the skin and soft tissues, intraabdominal, and gynecologic infections, and surgical prophylaxis.

Cefmetazole and cefoxitin are classed as third-generation cephems. Flomoxef and latamoxef, which are in a new class called oxacephems, have been classified as fourth generation cephalosporins.

In 2015, ceftolozane/tazobactam and ceftazidime/avibactam received US FDA approval. Together, these new cephalosporins have been referred to as fifth-generation cephalosporins.

The antibiotic may be used for patients who are allergic to penicillin due to the different ß-lactam antibiotic structure. The drug is able to be excreted in the urine.

As per drug safety alert issued by IPC on March 17, 2022, cephalosporins are linked with fixed drug eruption, a distinctive cutaneous allergic reaction that characteristically recurs at the same site(s) on re-exposure to the medication.

Healthcare professionals and patients have been advised to closely monitor the possibility of the above ADR associated with the use of cephalosporins. If such a reaction is encountered, it needs to be reported to the NCC-PvPI for suitable action.

IPC had earlier also flagged drug safety alerts revealing that anti-inflammatory drug, ibuprofen was also linked with fixed drug eruption while Cefazolin, a cephalosporin antibiotic, was associated with acute generalized exanthematous pustulosis (AGEP).

Besides this, it had earlier also flagged drug safety alerts revealing that popular blood pressure drug, Losartan was associated with muscle spasm while diclofenac, a NSAID, was linked to skin hyperpigmentation.

Dimethyl fumarate, used for relapsing-remitting multiple sclerosis, was associated with adverse drug reaction alopecia, according to the preliminary analysis of ADRs from the PvPI database.

PvPI was implemented by the CDSCO 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. PhamaBiz