E-DRUG: UK withdraws paracetamol + dextropropoxyphene combination
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[crossposted from Druginfo with thanks; WB]
Hi all
Earlier the MHRA had indicated that it was reviewing the registration of what they call "Co-proxamol" - the combination of paracetamol and dextropropoxyphene. The CSM has now decided that:
"* In relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are
caused by inadvertent overdose. Pharmacokinetic and pharmacodynamic
interactions with alcohol further reduce the threshold for fatal toxicity.
* There is no robust evidence that efficacy of this combination product is
superior to full strength paracetamol alone in either acute or chronic use.
* It has not been possible to identify any patient group in whom the risk:benefit may be positive.
* Co-proxamol products should be withdrawn altogether over the next 6-12
months.
* During the withdrawal phase, interim restrictions and warnings regarding the use of co-proxamol should be introduced to the product information."
It noted that "Each year there are 300-400 fatalities following deliberate or accidental drug overdose involving co-proxamol in England and Wales alone." - are there arny comparable data for SA? This is a widely used product.
The Q&A fromj the MHRA site is below - here's the advice:
"Indications:
* For the treatment of mild to moderate pain in adults where first line analgesics have proved ineffective or are inappropriate. Co-proxamol should not be used for any acute pain indication.
* Co-proxamol therapy should not be initiated in new patients.
* Co-proxamol should not be used in patients aged <18 years
Co-proxamol is contraindicated in:
* Patients who are alcohol-dependent or who are likely to consume alcohol
whilst taking co-proxamol.
* Patients who are suicidal or addiction-prone.
Special warnings to give your patients:
* never exceed the recommended dose.
* never consume alcohol while taking a course of co-proxamol
* Dispose of any unused supplies of co-proxamol (through a pharmacist) as
soon as possible after completing treatment."
Should this be followed immediately by an MCC review? The other combination that is probably overused in SA is paracetamol+meprobamate. Should that also be reviewed?
regards
Andy