MedShoop.com

Twenty years after doctors were warned that a painkiller taken by 1.7m people a year was linked to suicides and accidental deaths, the government announced yesterday it was to be withdrawn.

Co-proxamol, also known by the trade names Distalgesic, Cosalgesic and Dolgesic, is involved in between 300 and 400 deaths every year. About a fifth of those are accidental, sometimes involving alcohol.

There has been concern about the dangers of the drug in overdose for decades. In 1985, after a review by the government’s Committee on the Safety of Medicines, the warnings to doctors and patients were strengthened.

In 2003, a research paper in the British Medical Journal made it clear that the drug was a problem. “Self poisoning with co-proxamol is particularly dangerous and contributes substantially to drug related suicides. Restricting availability of co-proxamol could have an important role in suicide prevention,” wrote Keith Hawton, a professor of psychiatry at the Centre for Suicide Research of Oxford University, and colleagues. The study found it was implicated in nearly one in five deaths from overdose.

The drugs licensing body, the Medicines and Healthcare Products Regulatory Agency, said yesterday that the 20-year-old warnings to doctors and in the patient leaflets had not had the desired effect. It announced that the painkiller would be phased out over 18 months, to allow time for patients to see their doctors and switch to an alternative.

“Whilst the risks of co-proxamol are well known to health professionals, the latest evidence is that the measures to strengthen the labelling … have been ineffective in reducing the high fatality rate involving both intentional and accidental overdose,” said Alasdair Breckenridge, the MHRA chairman.

The painkiller uses a combination of paracetamol and a minor opioid called dextropropoxyphene, and can only be prescribed by doctors. Patients take it for mild to moderate pain in a number of conditions, including arthritis. Reviews have shown, however, that it is no more effective than paracetamol alone.

The National Institute of Mental Health in England has adopted a suicide-reduction strategy which hopes to cut the number of deaths by overdose. The institute believes that reducing access to the means of suicide is important. In 1998, action was taken over paracetamol. The law was changed to limit pack sizes to 16 tablets in general stores and 32 in pharmacies.

The CSM said there was no need for patients to stop taking co-proxamol immediately. “Co-proxamol will be phased out of the market place gradually to give patients time to discuss their treatment with their doctor and change to a suitable alternative,” said the committee’s chairman, Gordon Duff.

“There is no need for panic or concern, and if patients have been taking co-proxamol continuously for a long time they should not stop without consulting their doctor.”