The union health ministry may once again ban the use of fixed dose combination (FDC) of flupenthixol + melitracen for human use as the ministry's two different expert committees have reconsidered the issue and once again recommended that the use of the drug should be discontinued from the country.
According to sources, the Drugs and Technical Advisory Board (DTAB) of the ministry agreed with the recommendations of the New Drug Advisory Committee (Neurology & Psychiatry) of the ministry that the use of the drug should be discontinued from the country.
The Advisory committee after deliberations felt that rationality and essentiality of continued marketing of this FDC is questionable as melitracen is reported to be not efficacious as a single agent in depression and flupenthixol use is associated with potentially serious neurologic side effects. The committee felt that flupenthixol is anti-psychotic drug and melitracen is an anti-depressant drug and the combination of these two drugs may leads to increase in extra pyramidal side effects.
Earlier on June 18 this year, the ministry had banned the FDC of flupenthixol + melitracen (which is sold as deanxit) in view of the fact that the drug was not permitted to be marketed in the country origin i.e Denmark as well as countries like USA, Britain, Canada European Union and Japan.
Meanwhile, the manufacturers of the product Lundbeck and Mankind Pharma moved court and the Karnataka High Court on August 14, 2013 quashed the notification and remanded the matter back to reconsider afresh and take a decision one way or other in accordance with the law.
FDC of flupenthixol with melitracen was approved on 28.10.1998 for the treatment of psychogenic depression, depressive neuroses, marked depression and psychosomatic affection accompanied by anxiety and apathy.