After a recently conducted worldwide clinical study on head injury, the organisers, the UK-based Medical Research Council, has asked drug regulatory authorities of 33 countries including DCGI to ask the companies marketing Methylprednisolone to delete the indication of use printed on the labels that drug is helpful for head injuries.
The outcome of CRASH (corticosteroid randomisation after significant head injury) trial, organised by the MRC and conducted at 400 hospitals worldwide, revealed that Methylprednisolone, a corticosteroid that has been used by patients with head injuries for the last 30 years, decreases the survival rates of patients.
MRC justified banning the usage of this corticosteroid for head injuries across hospitals round the globe.
In India, the study was conducted at MIND (Manipal Institute of Neuro Disorders), spearheaded by Dr. N K Venkatramana, director MIND. He had immediately stopped the use of the drug after the study.
Dr. Venkatramana stated that the 100 patients from Manipal who participated in the trial reported no drug reactions. Sourcing patients for the trial was not a problem at Manipal as an average of 5 to 10 head injury cases are admitted daily, he said.
"Some reports appeared in the media that Methylprednisolone is harmful for head injury is not true. In the study conducted here, we found that it couldn't give the desired result and it didn't improve the outcome. But it is still found useful in optic nerve injury," Dr. Venkatramana told Pharmabiz.
"In the backdrop of the recent study, MRC has informed the result to the authorities in 33 countries including DCGI, UK MHRA, US FDA," he added.
According to a release from MRC, the study included a total of 10,008 patients and found that 21 per cent of those given the corticosteroids died within two weeks compared with 18 per cent of those on the placebo treatment. Results showed that the relative risk of death from all causes within two weeks was 18 per cent higher among patients randomised to corticosteroids as compared with those given placebo.
In all, 1052 out of 4985 people died in two weeks in the corticosteroid group (21 per cent) compared with 893 out of 4979 among those randomised to placebo (18 per cent), amounting to an extra three deaths in every 100 patients, the release says.
The Medical Research Council (MRC) is a national organisation funded by the UK Government.