About a month ago (7th January 2013) the MHRA published a report on Levothyroxine.
One of the reasons given for producing the report was that they had received a number of reports (Adverse Drug Reactions – reported by the Yellow Card system). And the number had grown considerably over the past few years.
When you look at the chart in the report, you can see that they only reached about 50 a year. This, without meaning to diminish their importance, is a small number.
Although I don’t sit here counting them up, but I feel that I can read at least fifty reports of adverse reactions to medicines, often but not always Levothyroxine, each month! And busy as we are, the number of members is still only a tiny percentage of those in the UK who have thyroid disorders.
I was very pleased that the MHRA did take notice and produce their report. But how much more notice would they take if they got not 50, but 500, or 5,000?
The absolute worst thing for us to do would for everyone here to suddenly invent Yellow Card reports! Maybe, though, if you genuinely feel that you have suffered an adverse reaction, you could see your way to making a proper report? And that applies whether it is is Levothyroxine or any other medicine. You do not need a degree in medicine or chemistry. Simply tell it in your own words as clearly and honestly as possible. Link appears below.
Extract from MHRA report:
The MHRA review of marketed levothyroxine tablet products was undertaken following the receipt of a small but persistent number of clinical and quality concerns from healthcare professionals and patients. These concerns focused on whether all tablet formulations of levothyroxine were equivalent and whether possible lack of equivalence might be explained by differences in levothyroxine content. While the number of these reports remains extremely low in comparison to the extent of usage of levothyroxine, queries directed to the MHRA have increased since 2006, suggesting a persistent level of concern from healthcare professionals and the patient population.
For levothyroxine products, these queries are mirrored by Adverse Drug Reaction (ADR or “Yellow Card”) reports which have also increased in the past 4 years as shown in Figure 1.
The “Yellow Card” scheme is the UK’s system for collecting and monitoring suspected adverse drug reactions including loss of efficacy and concerns with the quality of medicines. Details on how to submit a “Yellow Card” report are provided in the following link to the relevant area of the MHRA website.
mhra.gov.uk/Safetyinformati...
The reported ADRs cover a wide range, from lack of efficacy and changes in thyroid function tests to nonspecific complaints such as fatigue, alopecia and pain. Out of 453 UK spontaneous ‘suspected’ ADR reports associated with levothyroxine, 87 reports describe reactions of lack of efficacy, product substitution issues, thyroid disorders, and thyroid and pituitary analyses investigation results associated with levothyroxine. In 15 ADR reports the reporter stated that the reactions occurred upon switching between different brands of levothyroxine, and 2 reports relate to issues with interchangeability between liquid and tablet forms. As product names are often not reported, ADRs associated with product interchangeability and/or reformulation may not always be identified.
Full report here:
mhra.gov.uk/home/groups/pl-...
Rod
Picture is a big yellow taxi because the word "yellow" so often reminds me of Joni Mitchell
