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These common antibiotics have new side-effects & will now come with warnings

India's drug watchdog tells manufacturers of Cefixime, Cefotaxime, Ofloxacin and 4 other drugs to ensure warnings on leaflets in drug packets. 

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New Delhi: Commonly-used antibiotics — Cefixime, Cefotaxime, and Ofloxacin — have more side effects than known, which will soon be mentioned in leaflets inserted into the drug packets.

In August last year, the Ministry of Health and Family Welfare had been informed by the National Co-ordination Centre for Pharma Covigilance Programme of India (PvPI), the government’s pharmaceutical watchdog, that seven common medicines had reported certain unknown side effects.

The Central Drugs Standard Control Organisation (CDSCO), the government’s drug regulating body, then deliberated on the PvPI’s observations. It has now decided to incorporate the side-effects in the package inserts or on promotional literature.

“All zonal and sub-zonal officers have been instructed to direct the manufacturers of these formulations to mention the additional reaction in the package insert or promotional literature of the drug,” reads a letter written sent to state drug controllers by Eswara Reddy, the drug controller general of India and head of CDSCO. The letter was sent out on 9 April.

All of the seven formulations — antibiotics Cefotaxime, Ofloxacin and Cefixime; Tranexamic Acid, used to control bleeding; antipsychotic drug Quetiapine; anti-rheumatoid drug Sulfasalazine and the anti-epileptic medicine Sodium Valproate — have been instructed to warn patients of the new side effects.

Also read: AIIMS is cracking down on the misuse of antibiotics

The new side-effects

According to the PvPI, a new side-effect of the antibiotic Cefixime — sold under brand names such as Zifi, Omnicef-O and Ziprax — is acute generalised exanthematous pustulosis (AGEP) — a serious condition, according to the International Journal of Molecular Sciences, where the skin erupts with rash and small red and white blisters.

Another popular antibiotic, Ofloxacin, which is used to treat urinary tract infection and pneumonia can cause Stevens-Johnson syndrome — a condition that is considered a medical emergency and requires treatment in a hospital. The syndrome is known to cause painful rashes and blisters on the skin and the mucous membranes of the mouth, nose, eyes and genitals.

Antibiotic Cefotaxime — sold under the brand name Cefotaxim, Biotax, Cefantral among others — can cause angioedema, a swelling caused under the skin due to the accumulation of the fluids.

Of the others, a possible side-effect of Tranexamic Acid is seizures, Quetiapine could cause involuntary leakage of urine and Sodium Valproate is found to be causing an overgrowth of gum tissue around the teeth.

So far, however, the commonly known side-effects of these antibiotics include nausea, headache, dizziness, vomiting, stomach pain among a few more.

Also read: After giant pharma push, China keeps Indian drug makers waiting


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