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Approval withdrawn for MCP drops with an active substance content of more than 1 mg / ml
Metoclopramide drops (MCP drops) that have an active substance content of more than 1 mg / ml can no longer be prescribed by doctors. This was announced by the Federal Institute for Drugs and Medical Devices (BfArM). For medicinal products containing metoclopramide that meet the limit, the technical information and package leaflet should be changed. However, there are no plans to recall funds from patients.
MCP drops with severe neurological and cardiovascular side effects Up to now, high-dose MCP drops have often been prescribed for nausea with vomiting. The active ingredient "stimulates peristalsis in the upper gastrointestinal tract and is said to alleviate the symptoms described". However, since MCP is associated with serious neurological and cardiovascular side effects, medication containing metoclopramides with an active substance content of more than 1 mg / ml may no longer be prescribed, as the BfArM reports. This implements the European Commission's implementing decision of December 20, 2013, which withdraws approval that exceeds the limit. According to the BfArM, the technical information and instructions for use should be changed for MCP drops that have a permissible active ingredient content.
In Germany, all MCP drops are affected by the revocation, all of which contain an active substance concentration between 4 and 5 mg / ml. This also applies to parenteral MCP preparations with an active substance content of more than 5 mg / ml and to suppositories with a single dose of 20 mg. For products containing metoclopramide, for which approval has already been waived by the license holder, the Federal Institute states that these are no longer marketable.
A recall of funds from patients is not planned. Only doctors should no longer prescribe or dispense the drugs. According to the BfArM, a so-called red hand letter should not be sent. In Germany, this type of information letter is used when pharmaceutical companies want to inform healthcare professionals, for example, about pharmaceutical risks or recall incorrect batches of pharmaceuticals.
MCP drops are particularly problematic for children. The revocation of approval for the high-dose MCP drops is carried out as part of a step-by-step process, the level II of which is to initiate a European risk assessment process. The neurological and cardiovascular side effects of the medicinal products should be assessed against the background of a poorly documented benefit. The risk-benefit assessment should be carried out for all application areas approved in the EU.
The European Medicines Agency (EMA) limited both the duration of therapy and the dose for the use of MCP. So it should only be used for a maximum of five days, which excludes the use in chronic diseases such as reflux diseases, gastroparesis and dyspepsia. In addition, the active ingredient should no longer be used in patients under the age of one, since severe neurological side effects have been observed, especially in children. The undesirable symptoms that can also occur in adults include restlessness, tiredness, dizziness and less often depression, headaches and movement disorders such as muscle cramps and tremors. MCP is suspected to be the most common trigger for drug-related movement disorders. In addition, the active substance can cause an increase in the level of prolactin, which in turn can lead to menstrual disorders, reduced libido and impotence.
According to the EMA, MCP should generally only be used as a second-line drug in pediatrics. A daily dose of a maximum of 0.5 mg of active ingredient per kilogram of body weight should not be exceeded. This dosage also applies to adults, although in future the standard dose should be 10 mg three times a day instead of four times 10 mg as before. According to the EMA, liquid oral medications containing metoclopramide should be limited to 1 mg / ml of active substance. (ag)
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