ISLAMABAD (Kashmir English): DRAP, the Pakistan’s Drug Regulatory Authority, has ordered the withdrawal of a batch of Anarob antibiotic drip after it was found containing harmful levels of bacterial toxins.
The DRAP order comes amid concerns of the antibiotic drip batch containing unsafe bacterial toxins.
Anarob Infusion is used to treat bacterial infections
Anarob Infusion is an intravenous antibiotic drip containing metronidazole, commonly used in hospitals to treat serious bacterial infections in stomach, lungs, skin, joints, and other parts of the body when oral medicines are not effective.
Drap’s Central Drugs Laboratory, via a medical product alert issued Tuesday, informed the DRAP that samples of the drug were declared “substandard” due to being out of specification for bacterial endotoxins.
“Use of this contaminated infusion may cause severe adverse reactions such as fever, chills, septic shock and life-threatening complications. Hospitalised and immunocompromised patients are at the greatest risk,” the DRAP warned.
It said DRAP field force and Provincial Drug Control departments were immediately directed to detect and remove the affected batch (H24219) from the market.
The authority hopes that the regulatory field force of all federating units also increase surveillance in the market to ensure the effective recall of the defective product.
Drap also directed all pharmacists and chemists working at distribution centres and pharmacies to immediately check their stocks and stop supplying the drug, with the remaining stocks being quarantined and returned to the supplier/company.
The authority also instructed that any adverse reactions or quality problems experienced with the use of the drug be reported to the National Pharmacovigilance Centre (NPC), using the Adverse Event Reporting Form.
“Consumers should stop using products bearing the affected batch number and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drap/ National Pharmacovigilance Centre,” the alert concluded.
In March 2024, DRAP directed a pharmaceutical company to recall a syrup, which is given to children to treat fever, from the market and advised health professionals not to prescribe it.
