The drugs had been suspended by the Health Ministry earlier this year. But following a safety review of these medicines by an expert committee, the Drugs Technical Advisory Board (DTAB) has now recommended that they be permitted for use, as they are given in smaller dosages and over few days, respectively.
However, the Board did not recommend revoking the suspension on anti-depressant Deanxit, whose manufacture and sale had also been discontinued this year.
In fact, Deanxit, along with Analgin and diabetes drug pioglitazone had been suspended in June over safety concerns. But the suspension of pioglitazone has already been revoked, and the drug is back in the market with warning – labels and riders of restricted use. The drug had been suspended on possible links to urinary bladder cancer.
Dextropropoxyphene should be allowed for limited use for cancer patients, and it needs to be labelled “for use in cancer patients for pain only”, the DTAB recommended. Experts observed that dextropropoxyphene was the only opioid drug available for treatment in cancer-related pain. The drug was banned in India after regulators in the US and Europe recommended against its use, as its risks outweighed benefits – there were concerns of toxicity to the heart.
During the safety evaluation, the expert committee found that the heart impact was with higher dosages of 600 mg, while Indian patients were prescribed 300 mg per day.
The committee streamlined the drugs usage, suggesting that dosages not exceed 300 mg per day, and that the drug be put under post-marketing surveillance, even a controlled clinical trial to evaluate its safety in Indian subjects. Companies were also asked to submit safety data on the Indian population for six-month periods.
As for Analgin (metamizole), it should be allowed for severe pain or pain due to tumour, and for bringing down body temperature when other medicines in the category fail, the DTAB said. The drug is given over few days and there were no “adequate reports” of side-effects linked to the drug, it added. Concerns over Analgin are linked to its impact on an individual’s white blood cells that further affected the body’s immunity.
The suspension of Deanxit (Flupenthixol with melitracen) remained unchanged as the expert committee found the “rationality and essentiality” of continued marketing of this combination drug questionable.
Melitracen was reportedly not efficacious as a single agent in depression and Flupenthixol use was associated with potentially serious neurologic side effects, the committee said.
In fact, it pointed out that since Flupenthixol was an anti-psychotic drug and Melitracen an anti-depressant drug, their combination could lead to increased impact on the nervous system. Though Deanxit was approved for local use in October 1998, the drug is not marketed in the country of its origin, Denmark, besides countries such as the US, Britain, Canada, European Union and Japan. Business line