Sumatriptan (nasal and oral) and zolmitriptan (oral) are to be partially removed from prescription-only status as of October 1, 2013. This is planned in the 15th Ordinance Amending the Prescription Drug Ordinance of the Federal Ministry of Health and the Federal Ministry of Consumer Protection.
Previously, two triptans, naratriptan and almotriptan, were available for self-medication. A prerequisite for dispensing them in a pharmacy is a prior, clearly diagnosed migraine from a doctor.
According to analyses by IMS Health, a total of 4.4 million triptan preparations were dispensed in pharmacies in 2012. 2.1 million prescription triptans (most commonly Maxalt®/rizatriptan) and approximately 2.3 million over-the-counter triptans (most commonly Formigran®/naratriptan) were requested by migraine sufferers in German pharmacies. This means that self-medication already exceeds prescriptions by doctors.
The advantage of self-medication is that patients have more options. If their supply runs out on Friday evening, they can obtain triptans without a prescription from a pharmacy. However, there are also several disadvantages: patients have to pay for the triptans themselves. This can be expensive, as one tablet costs between 3 and 5 euros, and several tablets may be needed per attack. A headache diagnosis cannot be confirmed at the pharmacy; a medical examination is essential. Follow-up examinations to detect cardiovascular diseases and complications may be omitted. This includes, in particular, the detection of headaches due to medication overuse. Preventive treatments through behavior and medication may be neglected, even though they are essential components of modern therapy. Therefore, migraine patients must always be accompanied by medical treatment.
Triptans are generally very well-tolerated and safe medications. The most common side effects of triptans include fatigue, dizziness, heaviness, circulatory problems, or, very rarely, chest tightness. They must not be used in patients with cardiovascular diseases such as heart attack, stroke, or high blood pressure, as well as those with liver disease.
The recent amendment to the German Prescription Drug Ordinance, issued by the Federal Ministry of Health and the Federal Ministry of Consumer Protection, includes a number of important precautions for self-medication. These are intended to ensure the safety of use. They are described below for sumatriptan and zolmitriptan:
The position “ Sumatriptan ” is formulated as follows:
“Sumatriptan – except for the acute treatment of the headache phase of migraine attacks with and without aura in adults between 18 and 65 years of age, after initial diagnosis of migraine by a physician and after use of a triptan under the supervision of a physician,
a) as a nasal spray for intranasal use in a dosage of 20 mg (calculated as sumatriptan) per unit dose and in a total quantity of 40 mg per pack, and
b) for oral use in pack sizes of a maximum of 2 tablets of 50 mg sumatriptan each and in a total quantity of a maximum of 100 mg sumatriptan per pack, provided that the product information and package leaflet are specified
a) the contraindications state that the drug must not be used
aa) to prevent a migraine attack,
bb) in the case of a history of seizures or risk factors that lower the seizure threshold,
cc) in case of liver or kidney dysfunction,
dd) in cases of high blood pressure,
ee) in hemiplegic, basilar or ophthalmoplegic migraine, and
b) is indicated under the warnings
aa) that the diagnosis of “ migraine ” must be made by a doctor,
bb) that a doctor must be consulted if the typical headaches last for more than 24 hours, if the severity of the symptoms has changed, or if the attacks occur more frequently, last longer, or are more severe, as well as in cases where the symptoms do not completely disappear between attacks,
cc) that patients with four or more attacks per month should be medically examined and treated,
dd) a description of symptoms that require medical consultation, as follows:
“Double vision, clumsy and uncoordinated movements, tinnitus, disturbances of consciousness, seizure-like movements or sudden appearance of skin rashes together with the headaches”,
ee) that adults who experience migraine symptoms for the first time after the age of 50 should consult a doctor to rule out serious causes of the symptoms,
ff) that elevated cholesterol levels, regular smoking or nicotine replacement therapy, significant overweight and diabetes mellitus (diabetes) are risk factors for heart disease that require medical assessment before treatment with sumatriptan, and that persons with a first-degree relative who has experienced heart disease before the age of 60 also have an increased risk of use,
gg) that women who take oral contraceptives at the same time have an increased risk of stroke,
hh) that in the case of migraine with aura, or if the migraine attacks have only occurred for the last 3 months or if the symptoms have worsened, medical advice should be sought, and
c) in the section “Fertility, pregnancy and breastfeeding” it states that the medicine should only be taken during pregnancy and breastfeeding on the express instructions of a doctor and
d) in the section “ Overdose ” it is stated that in case of an overdose a doctor must be consulted immediately -”.
The position “ Zolmitriptan ” is formulated as follows:
“Zolmitriptan – except for the acute treatment of migraine headaches with and without aura in adults between 18 and 65 years of age, after initial diagnosis of migraine by a physician and after use of a triptan under the supervision of a physician, in solid preparations for oral administration in concentrations of 2.5 mg per unit dose and in a total quantity of 5 mg per pack, provided that the product information and package leaflet are specified
a) the contraindications state that the drug must not be used
aa) to prevent a migraine attack,
bb) in the case of a history of seizures or risk factors that lower the seizure threshold,
cc) in case of liver or kidney dysfunction,
dd) in cases of high blood pressure,
ee) in hemiplegic, basilar or ophthalmoplegic migraine, and
b) the warnings state aa) that the diagnosis of “ migraine ” must be made by a doctor,
bb) that a doctor must be consulted if the typical headaches last for more than 24 hours, if the severity of the symptoms has changed, or if the attacks occur more frequently, last longer, or are more severe, as well as in cases where the symptoms do not completely disappear between attacks,
cc) that patients with four or more attacks per month should be medically examined and treated,
dd) a description of symptoms that require medical consultation, as follows:
“Double vision, clumsy and uncoordinated movements, tinnitus, disturbances of consciousness, seizure-like movements or sudden appearance of skin rashes together with the headaches”,
ee) that adults who experience migraine symptoms for the first time after the age of 50 should consult a doctor to rule out serious causes of the symptoms,
ff) that elevated cholesterol levels, regular smoking or nicotine replacement therapy, significant overweight and diabetes mellitus (diabetes) are risk factors for heart disease that require medical assessment before treatment with zolmitriptan, and that individuals with a first-degree relative who has experienced heart disease before the age of 60 also have an increased risk of use,
gg) that women who take oral contraceptives at the same time have an increased risk of stroke,
hh) that in the case of migraine with aura, or if the migraine attacks have only occurred for the last 3 months or if the symptoms have worsened, medical advice should be sought, and
c) in the section “Fertility, pregnancy and breastfeeding” it states that the medicine should only be taken during pregnancy and breastfeeding on the express instructions of a doctor, and
d) in the section “ Overdose ” it is stated that in case of an overdose a doctor must be consulted immediately -”.
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