In response to recent days' debate about the safety of the arthritis medicine diclofenac, the Danish Health and Medicines Authority urges doctors to carefully follow the restrictions and precautions for use that are already described in the medicine's summary of product characteristics and on the Danish website medicin.dk:
- Patients with severe heart failure should not be given arthritis medicine of the NSAID type (nonsteroidal anti-inflammatory drug) - such as diclofenac, just as patients with hypertension or other heart disease should only be treated with an NSAID product, including diclofenac, after careful consideration.
- Arthritis medicines of the NSAID type are to be used at the lowest effective dose for the shortest duration necessary to minimise the risk of undesirable effects.
The European Medicines Agency (EMA) is already reviewing the safety of the arthritis medicine diclofenac, etc. with participation from the Danish Health and Medicines Authority.
The review will presumably end in July, and the Danish Health and Medicines Authority will follow the recommendation of EMA if there are changes to the way in which the medicine should be used.
About the products
NSAIDs constitute a large group of similar drugs which alleviate pain and swelling associated with arthritis and other inflammatory diseases. NSAIDs are primarily used to treat mild pain, arthritis and back pain as well as migraine.
In Denmark, the consumption of diclofenac is decreasing, but the Danish Health and Medicines Authority nonetheless assesses it to be too high - particularly given that the Institute for Rational Pharmacotherapy (IRF) does not recommend the products.
Previous studies on arthritis medicines
A number of epidemiological studies (including a recent Danish study from 2011: Circulation: Duration of Treatment With Nonsteroidal Anti-Inflammatory Drugs and Impact on Risk of Death and Recurrent Myocardial Infarction in Patients With Prior Myocardial Infarction) have shown that diclofenac poses the greatest risk of heart-related adverse reactions among the most frequently used NSAIDs.
In particular blood clots in the brain and heart, but also the risk of arrhythmia and atrial fibrillation. Ibuprofen and in particular naproxen are associated with the lowest or almost no risk.
The latest Danish study also showed that treatment of less than one week could cause an increased risk of blood clots in the heart in patients who had previously had a blood clot in the heart. Furthermore, the study showed that the risk of blood clots increases when the patient is given a higher dose.
Danish Health and Medicines Authority brought up issue in the EU
The results of the studies were discussed in the European Pharmacovigilance Working Party, PhVWP, in September and October 2011.
Against this background the Committee for Medicinal Products for Human Use under EMA started a review in October 2011 on the safety of NSAIDs to obtain an assessment of whether the product information needed to be clarified with respect to the duration of treatment and the possible risk of atrial fibrillation and atrial flutter.
Previous information about the risks of arthritis medicines
The Danish Health and Medicines Authority has previously posted information about the risks and the above-mentioned safety review on www.dkma.dk and in the newsletter 'Danish Pharmacovigilance Update'.
The Institute for Rational Pharmacotherapy (IRF) also reviewed the Danish study in 2011: NSAIDs and risk of atrial fibrillation (in Danish only)
On IRF’s National Recommendation List no NSAIDs are listed without restrictions for use. Many of the products, including diclofenac, are not recommended and the remainder are all recommended with restrictions for use. M01 and M09 NSAID, glucosamine and hyaluronic acid (in Danish only)
Promedicin.dk has also posted information about the new warnings (in Danish): NSAID and increased risk of blood clots - including under the individual products such as Diclon® (diclofenac): Diclon®- Diclon Rapid - Diclofenac