Dr Esteve Protests Droxicam Letter

The Spanish Health Ministry has sent an official letter to Laboratorios Dr Esteve SA informing the company that it has started an administrative procedure for the precautionary suspension of the distribution and sale of the company's anti-inflammatory drug droxicam in Spain.

The decision is based on recommendations made by the Spanish National Pharmacovigilance Committee after reviewing adverse reaction data. The Committee believes it has found evidence for a cause/effect relation between droxicam and hepatic toxicity.

Responding to the move, Dr Esteve has said that it does not agree with the "incomprehensible" decision, and intends to exercise its right of appeal in an attempt to get the suspension reversed. In a statement, the company said that a higher link between droxicam and hepatotoxicity compared to other non-steroidal anti-inflammatories has not been established, and adds that its product is no worse in this regard than other drugs of this type.