Why only triptans nine days a month?
What do you do, when you have migraines more than 9 days a month? Your doctor most likely tells you not to take too many triptans, and may only give you a prescription for 9 doses a month. You find other medicines – most likely painkillers available without a prescription. Or you consider preventive medicines, which for the majority of migraineurs have only little better effect than placebo, and a host of side effects.
Where did the limit on triptans originate?
The limitation of triptans was first mentioned in a letter to the American doctors from a group of U.S. insurance companies 13 years ago (that is in 2000). The health insurance companies wanted to cut their outlay to the expensive triptans, and stated – with no references to clinical tests but a mentioning that FDA had more data – that they would only subsidise 9 Sumatriptan tablets of 100 mg, or 18 tablets of 50 mg per month, and equivalent doses of other triptans (see box). This turned out to save the insurance companies $US 14 a month per migraineur insured.
The Danish Migraine Association asked FDA about the reference to their data and received this reply, March 2013:
” We are unable to provide you with the reference that you are looking for. The labelling for triptans states that the safety of treating an average of more than 4 headaches in a 30-day period has not been established.”
The leading migraine doctors caught the idea and the limitation in triptans to 10 a month was first introduced with an undocumented reference to FDA, in a paper published in 2003. The limitation was then included in the International Classification of Headache Disorders, 2nd Edition in 2005. A footnote in the Classification explained that the limitation is based on the ‘expert opinion’. That is, translated to plain words, an admission that no solid data were available. Or, you may say, that the doctors believe, but have no evidence, that the migraineurs should take triptans no more than 9 or 10 days per month. In the transformation from the insurance companies’ limitation in the subsidies to a ‘medical truth’, the actual amount of the active ingredient (i.e. 900 mg sumatriptan, either as 100 mg tablets or as 50 mg tablets) was changed to ‘doses’, and in some countries subsequently to days with triptans per month.
|American health insurance companies’ original recommendations
|| 25 mg=36 tablets or 50 mg=18 tablets or 100 mg=9 tablets
|Sumatriptan nose spray
|| 8 injections
|| 1 mg=25 tablets or 2.5 mg=10 tablets
|| 2.5 mg=18 tablets or 5 mg=9 tablets
||5 mg=24 tablets or 10 mg=12 tablets
Is there no evidence at all for the 9 day limit?
A very small study on the development of medicine induced headache, including 38 migraineurs, was published in 2002. It turned out that it took around 1.7 year of taking triptans 15 to 20 days a month to develop medicine induced headache. The risk was highest for developing medicine induced headache if the triptans were spread evenly over the days in the month. But the conclusion of the paper nevertheless stated that migraineurs should take triptans no more than 10 days per month.
Finally, the American Migraine Prevalence Study (results first published in 2008) has recently (in 2012) been cited as the documentation that medicine induced headache most often develops if you take more than 10 triptan doses per month. However, the Prevalence Study-paper from 2008 includes a model (that is a prediction, not real data) that indicates that the risk of developing medicine induced headache is 10% if you take triptans 10 days a month, and 30% if you take triptans 15 days per month. The model is based on data from 209 migraineurs, who developed medicine induced headache. Another paper from 2002 looked at how many triptans British migraineurs took. 10% of 338 triptan users took more than 10 doses per month. 60% of the triptan users worried about loosing their job because of their migraine. The data were from before the time of restrictions in triptans.
So yes, there is some documentation that more triptans increases the risk of developing medicine induced headache. But the magic numbers of 9 or 10 days or doses of triptans as a fixed limit are not substantiated.
How many are affected?
Nevertheless millions of migraineurs around the world have access only to a supply of triptans that is far more limited than necessary. The limitations may be financial (only subsidies for the first 9 or maybe 10 doses), or imposed by the prescriptions. Same time migraineurs in other countries (e.g. Britain or Sweden) may have the option of buying unlimited numbers of triptan doses (no subsidies) over the counter, if they can afford it.
We do not know exactly how many people live with fewer triptans than they need to treat their migraines. We do know that around 11% of all adults suffer from migraines. If the British usage of triptans is still valid, 10% of the migraineurs have migraine more than 10 days a month – that is around 1% of all adults. Or in round numbers 1% of 1 billion adults in Europe and N. America alone – that is a stunning 10 million people!
What are the consequences?
These migraineurs face a problem many days per month. They wake up with a migraine. They fear they will lose their job if they have too many days sick. So they can either try to grit their teeth and make it through the day, with the assistance of whatever pain medicine they can muster, or they can call in sick. The choice is probably obvious – find some medicine and cope as best you can.
Over the counter painkillers have some nasty side effects. Codeine has recently been identified as the main cause of medicine induced headache if it is taken daily. Medicine induced headache may appear within the first 30 days with codeine. Aspirin may cause stomach ulcers, and paracetamol will damage the liver if taken in slightly higher doses than the maximum indicated in the information slip.
Codeine’s inducement of medicine induced headache is new knowledge, first published this year (2013). But knowing that codeine is readily available only makes the limitations in the availability of the triptans even more ridiculous.
Medicine induced headache is debilitating
You wake up most days with a migraine or 'just' a headache. Maybe not a thunderous migraine attack, but definitely worthy of medication. The headache varies between migraine like and more like tension type headache. It kreeps up on you gradually - you need to take medicine a few more days a month. And suddenly you take headache medication every day. And it does not have as much effect as it used to have. And the headache comes again next day, and the next…
Keeping a job while suffering from medicine induced headache is not easy. Work performance is reduced, sick days are tempting. The boss may not be too pleased, and the job may be lost. Having a nasty headache pretty much every day is not the ideal situation when job hunting. Unemployment and consequent financial problems are imminent. All because of the limitation in the number of triptans available, and the subsequent use of over the counter medicine.
The only 'cure' for medicine induced headache is to stop taking the pain killers - not all that easy, if you need to earn a living every day. It takes weeks without the offending medicine(s) to get out of the medicine induced hedache.
It does not make sense for the national finances nor for the individual, who has daily headaches and a much reduced life quality and earning capability, that 10 million adults in Europe and North America (as well as all those in the rest of the world) have to rely on pain killers that may give them medicine induced headache, stomach ulcers, liver damage or death from a few too many tablets.
For the sake of saving $US 14 a month per migraineur in insurance costs in the USA.
This information was first published in May 2013 in MigræneNyt, the Danish Migraine Association's member magazine. The text has been edited to suite an international readership. Please refer to MigræneNyt (MigraineNews) May 2013 page 6 - 7, if you cite this information.