Lancet highlights potential dangers with the most commonly prescribed pain killers

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Study analysing the results of 754 clinical trials of Non Steroidal Anti Inflammatory (NSAID) Drugs, including diclofenac, ibuprofen, naproxen and the COX-II inhibitors confirmed that these drugs significantly increased risks of cardiovascular side effects, including death, and gastrointestinal problems including internal bleeding.

This is yet further confirmation of the potentially fatal risks of this commonly prescribed class of painkillers.

The renowned medical journal The Lancet has recently published* a study by Oxford University, which confirms the potential dangers in a class of drugs commonly prescribed in patients with chronic diseases such as osteoarthritis. The study analysed the results of 754 clinical trials of Non Steroidal Anti Inflammatory (NSAID) Drugs, including diclofenac, ibuprofen, naproxen and the COX-II inhibitors: celecoxib, rofecoxib, etoricoxib and lumiracoxib. It confirmed that these drugs significantly increased risks of cardiovascular side effects, including death, and gastrointestinal problems including internal bleeding.

This is yet further confirmation of the potentially fatal risks of this commonly prescribed class of painkillers: In 2009 a Danish national cohort study involving millions of people showed that taking ibuprofen, diclofenac, naproxen, rofecoxib and celecoxib significantly raised the risk of death and heart attack, even after a short treatment period**.

Prof Dr. Martin Wehling, director of the Institute of Experimental and Clinical Pharmacology and Toxicology, Mannheim, University of Heidelberg, said: “The Lancet article clearly demonstrates what has been known for a while, that NSAIDs have significant side effects. Products such as VIOXX® (rofecoxib, representing a supposedly safer type of NSAID) which grew to be a $1bn + seller were removed from the market because of these health concerns. An often quoted US study*** attributes 16,500 unnecessary deaths a year in America to NSAIDs; estimates for lethal bleeding complications range from 1,100 to 2,200 a year here in Germany. Adding cardiovascular deaths as the other main complication, unsafe NSAID use may claim 3,000-4,000 lives a year in Germany which is close to the 4,200 deaths you would derive from the US figure by simple adjustment of population size."

Putting this in context, according to Federal statistics this NSAID death toll is more than all the 3,657^ German deaths caused by road accidents in 2010 (the latest year for which information is readily available).

Thankfully, a recent article in Rheumatology^^, one of the world’s leading medical journals on arthritis, provides a potential solution. The article established that Flexiseq™, an innovative new drug-free way of treating the pain of arthritis is just as effective as one of the drugs that was confirmed in the above report to increase the risk of serious or fatal side effects.

Prof Bolten, Director Klaus Miehlke-Klinik, Rheumatologie, Wiesbaden, Germany, said: "For topical Flexiseq, the study showed the same pain and stiffness reducing qualities as oral celecoxib. As it does not contain any NSAID (or other pharmaceutical ingredient), side effects are very rare and it does not interact with other drugs. Therefore the many elderly osteoarthritis patients with cardiovascular problems, in which NSAIDs are contraindicated, can be treated at low risk.”

Professor Conaghan, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, lead author of the Rheumatology study said: “Most people with osteoarthritis live with chronic pain that interferes with their daily activities. Many can’t take or can’t tolerate current oral analgesics because of side effects. There is therefore a huge unmet need for effective and safe analgesics for osteoarthritis. The new study is interesting because it suggests that a novel topical therapy, that doesn’t include a topical anti-inflammatory drug, may help osteoarthritis pain."

Flexiseq has been awarded the Innovation 2013 Award by the Federation of German Pharmacists. It is currently available in Germany, where Flexiseq was developed and is now manufactured, and two initial export countries, Malaysia and Ireland, but clearly Flexiseq has global potential to be a major and important new product in the treatment of joint pain.

References:

*Coxib and traditional NSAID Trialists’ Collaboration. “Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta analyses of individual participant data from randomised trials.” The Lancet, 30 May 2013 (published online doi:10.1016/50140-6736(13)60900-9)

**EL Fosbøl et al.”Risk of Myocardial Infarction and Death Associated With the Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Among Healthy Individuals: A Nationwide Cohort Study.” Nature Clinical Pharmacology & Therapeutics, 2009: 85 (2) 190 - 197

***Singh G, “Recent considerations in nonsteroidal anti-inflammatory drug gastropathy” American Journal of Medicine 1998. http://www.ncbi.nlm.nih.gov/pubmed/9715832

^Road accident data 2010 Federal Statistical Office Germany

^^Conaghan P et al; “A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis.” Rheumatology, 2013 http://rheumatology.oxfordjournals.org/content/early/2013/03/27/rheumatology.ket133.abstract

Notes for editors:

Sequessome Technology®

FLEXISEQ employs Pro Bono Bio’s patented Sequessome Technology rather than an active pharmaceutical ingredient to target a root cause of the pain and stiffness associated with OA, relieving pain with comparable efficacy to celecoxib, a leading prescription drug commonly used for treating OA. Sequessome Technology utilises nanostructures called Sequessome™ vesicles that cross the skin barrier after the gel's topical application and migrate through various tissues to the target joint. Once inside the joint, Sequessome vesicles accumulate on the damaged cartilage forming a lubricating layer.

In this way Flexiseq acts physically to directly bio-lubricate the joint. All the elements of Flexiseq that reach the joint to bio-lubricate it are defined as GRAS (Generally Recognised as Safe) by the US FDA. Pharmaceuticals such as NSAID’s use chemical interference and dose the entire body which is why, while they can help for short periods, they are much more dangerous for long term use and are contra indicated for osteoarthritic patients with other conditions such as heart disease, high blood pressure, gastric disorders or asthma. Joint pain associated with OA is obviously a long term condition, making a long term benign bio-lubricating treatment such as Flexiseq particularly appropriate.

This targeted, physical mode of action crucially means there are no drug-to-drug interactions with FLEXISEQ as it is not itself a drug and, as a result, it can be used by patients who may be taking a variety of medications for other diseases, without increasing their drug burden. This is particularly important for people suffering OA as they are typically over 50 years of age and are often on other medication for other ailments.

Flexiseq is expected to be launched in the UK, Austria, Singapore, Hong Kong and Malta before the end of 2013.

About Pro Bono Bio

Pro Bono Bio is an innovative healthcare company launched in 2011. Pro Bono Bio launched FLEXISEQ in Germany in the first half of 2012.

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Martyn Smith
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