Reaction to injectable drug worries haemophiliacs

Samaan Lateef

Tribune News Service

Srinagar, May 27

Panic has gripped haemophilia patients of Shri Maharaja Hari Singh (SMHS) Hospital here after several of them reported adverse reactions to an injectable drug.

Patients reported increase in heart rate, dizziness and breathlessness.

Some haemophiliacs developed tachycardia (abnormally fast heart rate) while some complained of cough and chest pain.

“Adverse reaction after administration of the injection factor VIII (Hemoral-A) to haemophiliac patients has been noticed by the medical officer of the SMHS and the same has been communicated to the Monitoring Haemophilia Committee,” reads a letter dated March 5 of the Medicine Department to the Medical Superintendent of SMHS Hospital.

It said the drug had been recently supplied to the hospital by the J&K Medical Supplies Corporation Limited.

Haemophilia is a lifelong genetic bleeding disorder that prevents clotting of blood. People with haemophilia do not have enough clotting factor --- a vital protein in the blood that controls bleeding.

Officials say there are around 2,000 haemophiliacs in Kashmir.

However, due to lack of diagnostic facilities, only 239 have been registered at SMHS Hospital.

Officials said SMHS Hospital had been administering the haemophiliacs with factor VIII injections from Baxter, Intas and Reliance companies since July 2011.

“Of the three companies, it has been noticed that patients developed adverse reactions --- mild to moderate --- from injections manufactured by Intas and Reliance. The injection factor VIII from Baxter has not show complications in patients,” said the report by the Medicine Department.

“If the authorities have any constraint regarding the use of factor VIII by other companies, a weekly to monthly review of the patients may be needed,” said Dr M Ismail, Associate Professor, Medicine Department, in his report.

The patients have also taken up the matter with Principal, Government Medical College (GMC), Srinagar, Dr Kaisar Ahmad, who has sought a report from the Pharmacology Department.

In its casualty assessment report, the Pharmacology Department of SMHS Hospital has said there was “possibility of side effects by the drug in three patients” while as two patients probably had shown adverse reactions after administering the injection factor VIII.

“We cannot say with certainty that the injection factor VIII has caused an adverse reaction because for that we need to administer the injection again which is unethical,” said a senior pharmacologist.

The report said the casualty assessment had been carried out in accordance with the guidelines of the World Health Organisation.

The Pharmacology Department has requested the hospital authorities to forward the cases to the Haemovigilance Programme of India for further necessary action.

The GMC Principal, who heads all associate hospitals in Srinagar, including SMHS, said the hospital authorities were reassessing the casualty of drugs used in the haemophilic patients. “We are keeping it (the drug) under a close watch and let me assure all haemophiliac patients that they are safe. They should not worry because the reactions noticed were minor and the incidence was not so high.”

Patients complain of dizziness

* Haemophilia patients of Shri Maharaja Hari Singh Hospital in Srinagar have reported adverse reactions to an injectable drug

* Patients reported increase in heart rate, dizziness, breathlessness and tachycardia (abnormally fast heart rate). Some of the patients also complained of cough and chest pain

QUOTE: “We are keeping it (the drug) under a close watch and let me assure all haemophiliac patients that they are safe. They should not worry because the reactions noticed were minor and the incidence was not so high” Dr Kaisar Ahmad, Principal, GMC, Srinagar