Drugs used to treat high blood pressure and chest pain are often prescribed with simvastatin, but there are fears the combination can cause unpleasant side effects
Thousands of people taking a common statin are to have their dose
reduced due to fears over side effects.
The medicines regulator has warned that patients taking one particular
type - simvastatin - at the same time as other drugs used to reduce high blood
pressure are likely to suffer more muscle aches and pains. And for the first
time, it has produced a patient leaflet to inform people of the changes being
made. Statins have been hailed as a wonder drug, which can slash cholesterol
and protect against a host of chronic illnesses.
But the MHRA is concerned that some people taking other drugs with them
could suffer painful muscle problems, lung disorders and kidney damage. Every
day eight million people in the UK take various statins, which cost as little
as 40p a day. Simvastatin is the most
frequently prescribed one; last year GPs gave out almost three million prescriptions
for it in England alone.
But studies have shown that patients taking simvastatin, particularly
the 40mg dose which is the most commonly prescribed in England, suffered more
problems if they were also on amlodipine and diltiazem. These are used to treat
high blood pressure and chest pain associated with heart disease and they are
often prescribed with simvastatin. The side effects are those usually
associated with statins, including muscle problems such as pain, tenderness,
weakness and cramps and more rarely muscle breakdown leading to kidney damage. These
occurred more frequently when patients were on both drugs at the same time.
Simvastatin is the most frequently prescribed statin in the UK, with GPs writing nearly three million prescriptions for it in England alone last year
The general advice from the MHRA is that patients should not stop taking
simvastatin. However, if they experience any muscle pain, weakness or cramps
whilst taking simvastatin, they should stop taking it and see their doctor as
soon as possible. Doctors may lower the simvastatin dose as the side effects
were less common when patients were on a 20mg dose, or switch them to another
statin. Despite advocates saying that everyone over 50 should be statins, the
side effects are well-documented.
Some taking the drugs suffer mild side-effects such as insomnia and
stomach upsets, but others complain of agonising muscle pain and there have
been reports about patients developing a rare but serious lung disorder. However
most experts still agree that the benefits of taking them far outweigh any
risks. Patients are being advised that
if they are taking simvastatin alongside either of the other two medications
their doctor may review their treatment at the next routine appointment.
An MHRA spokesman said: 'The MHRA is committed to public health and
continuously monitors the safety of all medicines. 'We have recently published
information on dosing recommendations for simvastatin which were updated due to
a small risk of an increase in side effects when it is used at higher doses in
conjunction with amlodipine or diltiazem. 'This advice is intended to optimise
the proven beneficial effects of statins while minimising any adverse effects
and should not be a reason for stopping statin treatment. We have advised that
patients continue their treatment and discuss this with their doctor at their
next routine appointment. 'The updated information has been highlighted in our
first Drug Safety Update article designed exclusively for patients, with the
aim that people taking these medicines can understand why their statin
treatment may have changed.'
Judy O’Sullivan, Senior Cardiac Nurse at the British Heart Foundation,
said: ‘This is not based on any new revelations about unknown side effects of
simvastatin. ‘We know that side effects with this drug are dose related –
the higher the dose, the greater the risk of developing muscle pain. Because
calcium channel blockers slow down the rate at which simvastatin is broken
down, the drug levels in the blood stream can be higher. ‘Therefore
patients taking both simvastatin and a calcium channel blocker should discuss
their dose with their GP at their next visit or when their prescription is due
for renewal. There are alternative statins available for prescription.'
Source: Daily Mail UK
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