KARACHI, Sept 25: A number of medical professionals have expressed reservations about the use of certain bupivacaine preparation, largely administered for spinal anaesthesia, sources in the health circle said.
Senior doctors and anaesthesiologists who claim to have identified some adverse effects after administering the spinal injection in question to patients, including male and female, have also approached different health authorities and the manufacturer of the solution.
Interviews conducted by Dawn revealed that during the last one and a half month over 30 cases of post surgery ill-effects were reported from Karachi, Hyderabad, and Nawabshah. In most cases, patients became disoriented and psychotic after 3-4 hours of taking the injection (Bupivacaine HCL) of a particular batch, said a couple of doctors.
It was learnt that patients in question, most of which were administered the spinal anaesthesia for Caesarean section, developed severe psychiatric or neurological problems after surgery. A couple of patients, including male, were also reported to have turned hysterical tearing off their clothes and jumping out of the beds and behaving as if they were scared of some hidden events.
At least seven cases of adverse effects were reported at the Sobhraj Maternity Hospital during the last one month, where patients reportedly were given the said injection belonging to a batch with an expiry date of Nov 2006, said an anaesthesiologist, Dr Shahzad at Sobhraj, adding that one of such patients, who was operated upon about a week back was still recovering at the hospital.
Doctors said that after surgery patients developed severe headache, nausea and vomiting, followed by fits-like state, severe irritability and unconsciousness or restlessness. These symptoms continue for 3-6 days and during this period patients are out under sedation.
The adverse events were reported from hospitals located in different areas of the city, including Nazimabad, Garden, SITE, Malir, and Gulshan-i-Iqbal. At the Civil Hospital’s anaesthesia section two such cases were identified, one of which had come from a private hospital in Malir.
Dr Saeeda Haider of Civil Hospital/ DUHS’s anaesthesia department, also confirmed the problem and said irrespective of the fact that patients finally got recovered and were discharged as normal individuals, these effects were very frightening for the doctors’ community as well.
Prof Nasir Khan Jakhrani, head of Anaesthesia and surgical intensive care unit, JPMC, said that cases of erratic behaviour were also identified in at least four patients in August and in order to avoid further risk he had already ordered to stop the use of spinal injection in question.
“After checking with our medical suppliers and anaesthesia operators, who are experienced people, I concluded that there was a possibility that some batch of the injection had run defective. I had also contacted the Karachi based manufacturer of the injection, which had promised to conduct an inquiry on its side and report back to me, but the report is still awaited”, he added.
Dr Shabeen Naz, Medical Superintendent, Sobhraj Hospital, said she had reported to the authorities concerned about the gravity of the situation and also contacted the firm producing the drug.
She said that the spinal injections in question were mostly in use for Caesarean sections for long, but some latest events indicated that there was some quality control problem with some batches of the drug.
Responding to a complaint about a batch of the injection from Dr Shabeen, the pharmaceutical company in question, however, said that a comprehensive investigation was conducted and no deviation was noted.
Samples from the batch in question were checked visually and no turbidity was detected, while assay for active drug, Bupivacaine hydrochloride and Dextrose was performed and no discrepancy was found, the company said.
The head of anaesthesiology department of the Dow University of Health Science, Prof Dr S Tipu Sultan, said that professionals who had not been able to know the exact number of problematic batch of injections, now, preferred to use similar preparations marketed by other companies.
“In stead of ignoring the complaints, the firm in question should come up with confidence building measures and discuss the issues with health professionals as well in order to eliminate the confusion”, he suggested.
In the meantime, expressing its concern Pakistan Society of Anaesthesiologists said that there had been more than 20 cases in which the patient after 4-5 hours of spinal anaesthesia got restless, while some needed ICU managements. Anaesthesiologists have been advised to refrain from using the disputed injections till the reason for the complication is sorted out, said Dr Zafar Shahid, president of the Society.
Pakistan Medical Association Secretary Dr Shershah Syed informed that he had requested the director-general, Ministry of Health, Pakistan, to look into this highly important healthcare issue and also initiate an inquiry.
He said that he had come to know that the drug company in question had withdrawn the ampoules belonging to the disputed batch from some pharmacies in the city.
