KARACHI: Several female patients at different hospitals have reported complications after being administered a commonly used spinal anaesthesia during labour over the past 10 days, it emerged on Friday.

Sources said the condition of some patients turned critical and they had to be shifted to intensive care units.

No exact data on the number of cases or mortality was available since the hospitals where these cases had been reportedly occurred simply declined to share information when contacts were made for verification.

The situation, sources said, had so far failed to attract due attention and required urgency from the health department that had limited itself to mere data collection and that job, too, had largely been left to the hospitals where the cases had been reported.

Draps asks company to withdraw stocks

The health authorities, sources said had neither called any meeting of the experts concerned so far, nor had asked health facilities to stop using the drug causing the adverse reactions.

More importantly, there was no exercise on the part of the health department to pick up suspected drug samples for investigation.

No forum, the sources said, was available to patients suffering in ignorance to seek compensation.

A July 13 letter of the Directorate General, Health Services, Sindh, says “It is to inform you that various hospitals of Sindh province have reported an increased number of adverse effects/events after administration of Sensocain (Bupivacaine) drug through route spinal anaethesia for Caesarean section.

“Therefore, you are hereby advised to provide data from all major hospitals under your jurisdiction where Caesarean sections are being carried out before 4pm sharply on a daily basis.”

It is addressed to the heads of all major tertiary care hospitals in the province, district health officers and directors of health services of Larkana, Hyderabad, Mirpurkhas, Shaheed Benazirabad, and Sukkur.

Director General Health Dr Juman Bahoto and representatives of the Brookes Pharma Pvt Ltd, the drug manufacturer, were not available for comments.

When contacted on the actions taken so far, a spokesperson for the health department said, “We will do an analysis (of the data received from health facilities and concerned officials) after two weeks.”

One patient dies

According to media reports, three cases of similar nature occurred on June 1 at the Mother and Child Hospital, part of the Pakistan Institute of Medical Sciences (Pims), Islamabad, where a patient died while two others recovered.

A week later, a drug control team visited the store of gynaecology ward in Pims and took six samples of medicines and surgical items for testing and sealed both the hospital and store. An inquiry is still under way.

Responding to the situation, the Drug Regulatory Authority of Pakistan (DRAP) in a July 14 letter asked Brookes Pharma to immediately withdraw all the stocks of the suspected batch of the product.

“Reports have been received from hospitals countrywide such as Patel Hospital, Karachi, Imam Clinic, Karachi, and Pakistan Institute of Medical Sciences (Pims), Islamabad, regarding the occurrence of various adverse drug events/reactions including neurological symptoms such as behavioural changes, psychosis, irritability, agitation, disorientation, photophobia etc, in patients after the administration of subject mentioned batch (Batch No. 099D2) of product Sensocain Spinal 0.5% injection.

“Keeping in view of above, you are directed to immediately recall all the stocks of suspected batch of product Sensocain Spinal 0.5% injection, alert your sales officers/suppliers/distributors to issue instructions to the pharmacies/hospitals, point of sales/purchase/use for the return of suspected stocks of product in question. And submit a comprehensive report to this division within three days positively.”

Cases in 2004

Speaking to Dawn, Dr Mirza Ali Azhar, who retired as the head of the anaesthesia department at Sessi Landhi Hospital, said it wasn’t the first time that a drug used for spinal anaesthesia caused adverse reactions.

“In 2004, I was the first to notice and report to the concerned company adverse reaction/s being caused by the drug, which claimed two lives. At that time, too, pregnant female patients were the victims of adverse reactions,” he recalled.

The company (not Brookes), he said, withdrew the entire suspected batch of the product from the market and since then no case of similar nature had been reported in the country.

Explaining the reasons, he said since the country lacked a culture of thorough scientific investigation, it appeared that there was a problem with only a specific batch of the drug.

“While we are hearing about a number of cases these days, I haven’t yet encountered a single case in which a female patient experienced adverse reaction/s despite using the same drug. It seems I am using the drug of a different batch number.”

According to Dr Azhar, also the past-immediate President of Pakistan Medical Association, the signs of adverse reactions appear in most cases after 24 hours and there is no harm to the baby.

He called for what he described as “fearless reporting of the cases” to avoid future complications in patients.

“Unfortunately, inquiries in our country are conducted either to hush up the matter or there is an ill-intention to target someone. Hence, people are reluctant to share information.”

Published in Dawn, July 16th, 2022