Posted by ed_uk on January 31, 2005, at 10:16:51
NB. In the US, co-proxamol is available as Darvocet. This information does not apply to the US.
Co-proxamol will soon be discontinued in the UK.
CO-PROXAMOL: OUTCOME OF THE REVIEW OF RISKS AND BENEFITS
1 What is co-proxamol?
Co-proxamol is a prescription only medicine used to treat mild to moderate pain.
It contains a combination of a low dose of paracetamol/acetaminophen (325 milligrams per tablet)
and a painkiller called dextropropoxyphene (propoxyphene). (Ordinary paracetamol tablets
normally contain 500 milligrams). Several pharmaceutical companies market it as
'Co-proxamol' and it is also marketed under the brand names Distalgesic,
Cosalgesic and Dolgesic.2 What is the problem with co-proxamol?
There is little evidence that co-proxamol is more effective in treating pain than
normal paracetamol in the recommended dose. Around 300-400 self-poisoning
deaths each year, of which around a fifth are accidental, involve co-proxamol.
Prescribers are aware of the serious risks to patients who exceed the
recommended dose on co-proxamol. The MHRA has conducted a review of the
risks and benefits of co-proxamol and the Committee on Safety of Medicines
(CSM) has advised that the balance of risks and benefits of co-proxamol is
unfavourable.3 What was the outcome of the review of the use of co-proxamol and
request for information on risk: benefit?The CSM, the independent expert body which advises the government on
medicines, has considered the responses to the public request for further
information on the risks and benefits of co-proxamol. After careful consideration,
the CSM has advised that co-proxamol should be withdrawn from the market on
the grounds that the benefits of taking co-proxamol are not considered to
outweigh the risks.4 If co-proxamol has been available for over 40 years, why has action only
been taken now?Co-proxamol has been marketed since the 1960's, and was firmly established as
a treatment for mild to moderate pain before modern standards of clinical
research. Current evidence is that previous advice in 1985 to strengthen
warnings about co-proxamol overdose has not impacted on the problem.5 When will co-proxamol be withdrawn from the market?
Co-proxamol will be phased out of the market place gradually over 6 - 12 months
to give patients time to discuss their treatment with their doctor and change to a
suitable alternative. 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.6 How will patients who use co-proxamol now treat their conditions?
There are a number of options for managing painful conditions and CSM has
recently issued advice. There is no need for urgent medical advice – patients
taking co-proxamol can have the management of their treatment reviewed at their
next routine check.7 If the CSM has advised that co-proxamol should be withdrawn from the
market why is it not being done immediately - is it safe for me to carry on
taking medicines containing co-proxamol until it is no longer available?The CSM advised that co-proxamol should be phased out over a period of time
rather that withdrawn from the market immediately, to give patients currently
taking the medicine time to discuss their medication with their doctor and move to
a suitable alternative. No medicine is absolutely free of possible side-effects. It is
important that you:
• Only take the medicine if it has been prescribed for you
• Always read the patient information leaflet supplied with your medicine
and follow the instructions carefully
• Do not take more than the recommended dose
• Never take it with alcohol, sedatives, tranquillisers or other medicines
containing paracetamol
• Store your medicine out of the sight and reach of children and adolescents
• Destroy any unused tablets or return them to your pharmacist as soon as
possible8 Is it safe to stop co-proxamol straight away? What else can I take?
If you have been taking co-proxamol continuously for a long time, you should not
stop without consulting your doctor. If you only take co-proxamol intermittently,
there is no problem with stopping straight away. Remember to destroy any
unused supplies or return them to the pharmacist as soon as possible. There are
other medicines available with or without prescription that do not contain the
ingredient dextropropoxyphene (DXP). Your pharmacist or doctor can advise you
on the choice available.
poster:ed_uk
thread:450512
URL: http://www.dr-bob.org/babble/20050128/msgs/450512.html