Healthy Skepticism Library item: 19319

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Harvey K
Ken Harvey: The risks from vague medicine labels
MJA InSight 2011 Mar 7;
http://www.mjainsight.com.au/view?post=Ken+Harvey%3A+The+risks+from +vague+medicine+labels&post_id=3572

Abstract:

TWO cases of salicylate intoxication caused by infant teething gels
containing choline salicylate were reported last month in MJA
InSight, following publication of “Lessons from Practice” in the MJA.

The authors noted that dosing this gel directly from the tube is
potentially inaccurate, increasing the risk of it causing chronic
toxicity. They also recommended that a warning label should be added to
these products.

In fact, the Therapeutic Goods Administration (TGA) is currently
conducting a consultation on “Required Advisory Statements for Medicine
Labels (RASML)”. This includes proposals for new labelling for all
non-prescription medicines containing choline salicylate. Unfortunately,
this information is buried on page 36 of a 49-page document and so, not
surprisingly, I initially missed the relevance of this RASML
consultation to the MJA article.

The RASML review has invited comment from five industry associations;
two pharmacy organisations and one consumer group ― but NO medical or
public health organisations. This omission is despite the fact that it
has been health professionals who have reported Australian and New
Zealand cases of salicylate intoxication caused by infant teething gels.

When I bought a pack of teething gel containing salicylate last week,
the directions and warnings on the pack were covered by a pharmacy label
(see image). This seems to regularly happen in pharmacies.

However, directions and warnings were printed on the tube and stated:
“Directions: Wash your hands, apply enough Bonjela gel to cover the tip
of your index finger, rub well into the affected area every 3 hours when
necessary. Warnings: Do not apply more than once every 3 hours. Do not
exceed the stated dose. Not suitable for babies under 4 months. If
symptoms persist seek medical or dental advice.”

The new warning proposed by RASML states: “Do not exceed the recommended
dose. Excessive or prolonged use can be harmful”.

Both the old “stated dose” and the proposed “recommended dose” label
warnings are ambiguous and unhelpful.

What is the recommended dose? For example, the “dose” obtained by
covering the tip of my index finger would be at least double that
obtained from my wife’s finger. And with the proposed labelling, what
does “excessive” and/or “prolonged” use mean?

Given that no duration of treatment is mentioned on either the old or
the proposed label it’s understandable that the parents of the two
children mentioned in the recent MJA article kept using choline
salicylate teething gels for several months. It is also likely that
other parents may do this regardless of the benign additional warning
proposed for the label.

In order to prevent future cases of salicylate intoxication from
teething gels containing choline salicylate, shouldn’t both the dose and
the duration of use for these products be better defined?

Asking these specific questions would be more likely to produce an
informed response for the TGA RASML consultation, especially if a
medical professional organisation were included to provide input.

A number of submissions to the TGA Transparency Review, which was
announced at the end of last year, have suggested that the TGA
proactively initiate debate on such matters using online and web
resources for health professionals, such as MJA InSight, and online
consumer forums.

Ironically, in 2009, the UK the Medicines and Healthcare Products
Regulatory Agency advised that teething gels containing salicylate salts
were no longer indicated in children under 16 years of age. As a result,
the sponsor of Bonjela reformulated the UK product eliminating choline
salicylate.

That approach certainly eliminates debate over labelling subtleties!

Dr Ken Harvey is an adjunct senior lecturer at the School of Public
Health, La Trobe University, and the CHOICE consumer representative on
the TGA Transparency Review Panel.