Meto doesn't really do much when it comes to nausea for me but it works really well for my gastroparesis with no side effects, while Domperidone doesn't work at all, so it's not a rule.
Hmm,,,,, other countries, other treatments!?
Excerpt from Pharmaceutical Newspaper
Metoclopramide drops (MCP) with an active ingredient content of more than 1 mg/ml are no longer marketable. The Federal Institute for Drugs and Medical Devices (BfArM) revoked the approval. All preparations available in Germany, which contain all concentrations between 4 and 5 mg/ml, are affected. Alternatives are rare.
The revocation also includes parenteral MCP preparations with a concentration of more than 5 mg/ml and suppositories with a single dose of 20 mg. The BfArM is thus implementing the recommendations for minimizing the risk of MCP-containing medicines, which the European Medicines Agency (EMA) made based on a reassessment of the benefit-risk ratio.
The background was the long-known risk of serious neurological side effects as well as the risk of rare but serious cardiovascular effects. Since the risks increase with dose and duration of therapy, the EMA imposed restrictions on both parameters.
In the future, MCP should only be prescribed for a maximum of five days.
This means that its use in chronic diseases such as gastroparesis, dyspepsia or reflux disease is taboo. The use of the active ingredient to prevent nausea and vomiting after operations, radiotherapy or chemotherapy is not affected. MCP can also continue to be used for the symptomatic treatment of nausea and vomiting, including acute migraines.
Since severe neurological side effects occurred, especially in children, the active ingredient will be contraindicated in children under one year of age, according to the EMA. In addition, MCP should only be used as a second-line drug in pediatrics. The EMA specifies a maximum daily dose of 0.5 mg of active ingredient per kilogram of body weight for both children and adults. The standard dose for adults should in future be 10 mg three times per day (previously 10 mg four times). Against this background, at the end of last year, the EMA experts spoke out in favor of limiting liquid oral dosage forms to an active ingredient content of 1 mg/ml.
Recall leaves a therapeutic gap
The market withdrawal raises the question of alternatives. MCP has a dual antiemetic effect. On the one hand, the central dopamine antagonist inhibits the chemoreceptor trigger zone in the brain, where the feeling of nausea arises and the urge to vomit is triggered. On the other hand, MCP eliminates an important trigger by promoting gastric emptying. Metoclopramide continued to be valued as a prokinetic, especially after the withdrawal of cisapride from the market. The 5-HT4 receptor agonist was withdrawn from market in 2000 due to cardiac side effects.
The central antiemetic effect of MCP would be dispensable thanks to alternatives, especially since they cause the extrapyramidal side effects. For example, studies indicate that ondansetron and dexamethasone are more effective at preventing postoperative nausea and vomiting than MCP. Diphenhydramine could also be prescribed more frequently in the future. Preparations containing domperidone are only of limited use as a substitute, as the EMA recently restricted the indication to nausea and vomiting due to cardiac side effects such as QT prolongation. The antiemtic should no longer be used to treat bloating or upper abdominal discomfort.
In its capacity as a prokinetic agent, erythromycin is considered an alternative, although it is not approved for this indication. The macrolide antibiotic stimulates the motilin receptors and thereby provokes accelerated gastric emptying. However, given the development of resistance, it should only be given for a very short time.
