Higher risk of heart attack by diclofenac

EU authority warns against analgesic diclofenac

23/11/2013

The EU's highest drug agency advises caution on diclofenac use. The active substance contained in numerous, prescription painkillers could lead to serious side effects and increase the risk of heart attack.

Warning of the EU authority
A new EU safety notice regarding the analgesic diclofenac causes patient insecurity. Already a few months ago, the EU's highest drug agency (EMA) issued a warning. As a result, a letter from the Austrian Federal Office for Safety in Health Care was sent to the local hospitals, doctors 'and pharmacists' chambers at the end of October, stating among other things: „The benefits of diclofenac outweigh the risks. However, data currently available indicate that diclofenac therapy is associated with an increased risk of arterial thrombotic events, such as increased heart failure and increased risk of heart attack.“

Most common prescription pain medication
The active ingredient diclofenac, which is considered to be an effective pain and anti-inflammatory drug, is present in Austria in 80 painkillers, such as Voltaren or Deflamat. Also in Austria diclofenac is the most common prescription painkiller. The drug could lead to serious complications from a thickening of the blood. The ratio is 1,000 to three, which means that three out of every thousand diclofenac-treated patients experience severe side effects.

Risk patients should abstain
People who suffer from heart failure, angina pectoris or the so-called intermittent clitoris, should completely abstain from diclofenac. Similarly, patients with circulatory disorders in the brain or after a heart attack. And careful handling of such painkillers is recommended to people who suffer from high blood pressure, lipid metabolism disorders or diabetes or who are smokers. Although healthy people could continue to be given safe doses of diclofenac, Graz pain specialist Andreas Sandner-Kiesling also warns: „In a patient who is overweight, may be diabetic, and has high blood pressure, the likelihood of having a serious side effect is given. If heart failure has or is an existing calcification of any vessel in the body, it means: Stay away from this medication.“

Rethinking in pain therapy required
The new findings became known when the results of a large investigation initiated by the UK Health Authority were available. These were then forwarded to the EU member states as well as the responsible authorities there. As a first step, the specialist and usage information for physicians and the patient information leaflets were revised. As Christoph Baumgärtel of the Austrian medicines authority explained, now also in the pain therapy must be rethought: „New and important is that now these drugs are now given only in the lowest possible dose and only for the shortest possible period. These long-term therapies, which used to treat patients partially - if they were chronic pain patients - for months or even years with diclofenac, should be a thing of the past. In this respect, it is not bad that this release of the drug agency within the medical profession has also caused a bit of unrest. It is a sign that this message has at least been accepted and read.“

Withdraw approvals for Diclofenac?
Diclofenac is one of the world's most popular painkillers and is one of the so-called nonsteroidal anti-inflammatory drugs (NSAIDs). The World Health Organization (WHO) lists ibuprofen and ASA on its list of essential drugs as NSAIDs, but not diclofenac. British and Canadian physicians had in an older issue of the journal „PLOS Medicine“ even written: „There are strong reasons for withdrawing its approvals worldwide.“ (Ad)