After six months of its ban in the Indian market on patient safety, the Union health ministry will soon lift the ban on dextropropoxyphene and will be allowed to be used in cancer pain subject to certain conditions including that the dose of the drug should not be more then 300mg per day.

According to health ministry sources, the Drugs and Technical Advisory Board (DTAB), the highest decision-making body in the Union health ministry on technical matters, has already recommended to the ministry that the use of the drug can be continued in cancer pain only subject to some conditions. Other conditions are that the package insert, promotional literature, labeling of the drug, etc. should clearly mention the “Use of drug for cancer pain only”; the firm should sensitize doctors for use of drug in cancer pain only; and the firm should also submit the safety data from Indian population within period of six months.

The DTAB took a decision to this effect at its meeting held on November 25 this year. In the meeting, the members noted that the reason for ban of the drug was that US Food and Drug Administration had on 19.11.2010 recommended against continued prescribing and use of the drug because new data showed that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. On request of US FDA, companies voluntarily withdrew the drug from the United States market. The Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA) also concluded that the benefits of dextropropoxyphene do not outweigh its risks, and recommended that all marketing authorisations for dextropropoxyphene containing medicines should be withdrawn throughout the European Union (EU).

Experts were however of the view that QT prolongation is with 600 mg per day of dextropropoxyphene whereas the dose of the drug in Indian patients is only up to 300 mg per day. The drug may be put under focused pharmacovigilance programme or shall have a well-designed controlled clinical trial for the evaluation of safety in Indian subjects. Some experts were of the view that dextropropoxyphene is the only opioid drug available for treatment of cancer pain.

Earlier on May 23 this year, the union health ministry had banned the use of dextropropoxyphene and its formulations on patient safety.