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[e-drug] New Restrictions on Popular Painkiller

E-DRUG: New Restrictions on Popular Painkiller
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[Please respond to Syed Ahmad <drugsafetyconsultant@gmail.com> with information 
about the status of diclofenac in your country.  See last par in this message- 
Moderator]

Dear E-druggers,

Diclofenac (Voltaren and others), a popular painkiller has been put on
prescription only status by the U.K. Medicines and Healthcare Regulatory
Agency (MHRA) effective January 15, 2015.  The MHRA cited concerns over
'increased risk of serious cardiac side effects in some patients,' which is
worsened by long-term or high-dose use as a reason for their action.  The
full press release associated can be found here:

https://www.gov.uk/government/news/diclofenac-tablets-now-only-available-as-a-prescription-medicine

In 2013, a study published in the journal PLOSMedicine by Drs. Patricia
McGettigan and David Henry examined the use of (NSAIDs) non-steroidal
anti-inflammatory drugs that elevate cardiovascular risk in 15 low-,
middle-, and high-income countries. The authors concluded that "diclofenac
has a risk very similar to rofecoxib, which was withdrawn from worldwide
markets owing to cardiovascular toxicity." They  recommended that 'diclofenac
should be removed from EMLs (Essential Medicines Lists)'. The full study can
be found here:

PLoS Med. <http://www.ncbi.nlm.nih.gov/pubmed/23424288#> 2013;10(2):e1001388.
doi: 10.1371/journal.pmed.1001388. Epub 2013 Feb 12.

In October 2014, Health Canada issued a safety notification, strengthening
the labeling of diclofenac because of increased evidence of potential heart
and stroke related risks with diclofenac-containing products in tablet and
suppository forms. The full information can be found here:

http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/diclofenac-eng.php

Interestingly, diclofenac has been associated with deaths of vultures in
several countries and there has been a call to ban its use as a veterinary
medicine. An article published in the newspaper Guardian in December 2014
states the following:

'Papers in scientific journals including Science and Nature have supported
a ban and stated that veterinary diclofenac poses an unnecessary threat for
the European vulture populations.' The full article can be found here:

http://www.theguardian.com/environment/2014/dec/15/eu-under-pressure-to-ban-diclofenac-to-protect-europes-vultures

Given that in most resource-limited countries, there is easy access to
prescription only medicines, it will be interesting to find the current
status of diclofenac in all countries especially low, and middle income
countries and if any action has been taken or anticipated following the U.K
action. E-druggers can write to me directly and I will try to summarize
their emails and post it to E-drug.

Best wishes,

Rizwan

Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Consultant with Special Interest to Strengthen National Medicines
Regulatory Authorities in Resource-limited Countries
Formerly (1998-2013) with the U.S. Food and Drug Administration
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
Email: drugsafetyconsultant@gmail.com
www.drugsafetyconsultant.com
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