Nausea and vomiting are among the characteristic accompanying symptoms of migraine. Studies show that the absorption of analgesics is delayed during migraine attacks. This is thought to be caused by impaired gastric peristalsis during a migraine attack. This provides the rationale for combining analgesics or triptans with prokinetic antiemetics: an enhancement of effect through accelerated and possibly also improved absorption.
Loss of appetite, nausea, and vomiting can accompany migraine attacks. Additionally, the stomach muscles are often impaired in their motility. Antiemetics (from the Latin "emesis," meaning vomiting) are intended to correct these functional disturbances during migraines. Furthermore, the reduced stomach motility during a migraine also means that the usual migraine medications, taken as tablets, are only transported with difficulty into the intestines. The desired effect is then not achieved. For this reason, antiemetics are recommended as an adjunct to the treatment of migraine attacks. These medications are intended to normalize stomach motility and thus improve the effectiveness of the migraine medication.
Antiemetics normalize gastrointestinal motility and relieve nausea and vomiting. Metoclopramide (MCP) is recommended at a standard adult dose of 20 drops. Rarely, fatigue, dizziness, or diarrhea occur as side effects. Very rarely, movement disorders such as involuntary mouth movements, throat and tongue spasms, head torsos, difficulty swallowing, or eye torsos may occur shortly after ingestion.
Metoclopramide (MCP) drops with an active ingredient concentration exceeding 1 mg/ml are no longer marketable and are being recalled. All preparations available in Germany contain concentrations between 4 and 5 mg/ml and are therefore all affected.
The reassessment is based on the known risk of severe cardiovascular and neurological side effects, particularly extrapyramidal symptoms and irreversible tardive dyskinesia. This risk increases with the dose used and the duration of treatment.
Metoclopramide drops (MCP) are therefore no longer available for the treatment of nausea and vomiting in migraine. The use of other dosage forms, such as tablets, is also no longer recommended for established indications, such as gastrointestinal motility disorders, gastroesophageal reflux disease, and dyspepsia.
In addition, further warnings were added to the product information and instructions for use, in particular regarding the QT-prolonging potential.
Domperidone and dimenhydrinate remain available as alternatives for the treatment of nausea and vomiting during a migraine attack.
Domperidone has antiemetic and prokinetic effects. Domperidone has fewer extrapyramidal motor side effects than metoclopramide. When taken during the prodromal phase of migraine, domperidone reduced the likelihood of a subsequent headache phase in two studies. Domperidone is available as tablets and suspension. The assessment of the prokinetic agent domperidone (e.g., Motilium) has also been revised. Its indications have been restricted to the symptomatic treatment of nausea and vomiting. Adults weighing over 35 kg should only use domperidone orally at a maximum dose of 10 mg up to three times daily or rectally at a maximum dose of 30 mg twice daily. Children and adolescents weighing less than 35 kg should only receive domperidone orally at a maximum dose of 0.25 mg per kg of body weight up to three times daily. Domperidone should not be used for longer than one week due to cardiac side effects. Cardiac arrhythmias, such as life-threatening QT interval prolongations, have long been known as undesirable effects; therefore, domperidone should only be used with caution in patients with heart disease or electrolyte imbalances.
Dimenhydrinate has antiemetic but not prokinetic effects. Therefore, dimenhydrinate is only a second-line treatment for migraine attacks, unless the sedative side effect is desired. Dimenhydrinate is available as coated tablets, syrup, chewable tablets, suppositories, and for intravenous and injectable administration.
The decision of the BFARM
The list of affected medications can be found here.
Risk outweighs benefit: EMA recommends restrictions on the use of metoclopramide
Precise dosing of MCP drops: A critical drug formulation in the age of discount contracts
After taking MCP drops over a period of several years, I developed side effects such as anxiety and panic attacks as well as cramping of the jaw (I sometimes couldn't get it apart and could therefore only speak through my teeth). I was also shaking all over. When I was lying down, my legs flew up. I never had to deal with this before taking the MCP drops. I also got diarrhea. My body has been hurting for about a year. I suffer from this a lot because my daily movement is very limited. I am 68 years old.