MCP drops Too high a dose of stomach drug

Authorization for MCP drops with an active ingredient content of more than 1 mg / ml withdrawn

04/18/2014

Metoclopramide drops (MCP drops) with an active ingredient content of more than 1 mg / ml may no longer be prescribed by doctors. This was announced by the Federal Institute for Drugs and Medical Devices (BfArM). For metoclopramide containing medicinal products that meet the limit, the leaflet and package leaflet should be amended. A recall of funds in patients is not planned.

MCP drops with severe neurological and cardiovascular side effects
High dose MCP drops have been widely prescribed for vomiting nausea. The active ingredient "stimulates peristalsis in the upper gastrointestinal tract and should alleviate the symptoms described". However, as MCP is associated with serious neurological and cardiovascular side effects, metoclopramide-containing medicinal products with an active ingredient content of more than 1 mg / ml may no longer be prescribed as of now, as the BfArM reports. This transposed the European Commission's implementing decision of 20 December 2013, according to which the authorization exceeds the limit. For MCP drops, which have a permissible active ingredient content, according to the BfArM according to the instructions for use and use be changed.

In Germany, the withdrawal affects all MCP drops, all of which contain an active substance concentration of between 4 and 5 mg / ml. This also applies to parenteral MCP preparations with an active ingredient content of more than 5 mg / ml as well as for suppositories with a single dose of 20 mg. For metoclopramide-containing products, which have already been waived approval by the license holder, the Federal Institute said that they were no longer marketable.

A recall of funds in patients is not provided. Only doctors should stop prescribing or dispensing the drugs. A so-called red-hand letter but should not be sent according to BfArM. In Germany, this type of information writing is used when pharmaceutical companies, for example, inform health care professionals about drug risks or want to recall incorrect batches of medicines.

MCP drops are particularly problematic in children
The revocation of the high-dose MCP drops is being carried out as part of a phased plan procedure, of which Stage II provides for the initiation of a European risk assessment procedure. The aim is to assess the neurological and cardiovascular side effects of the drug against the background of a poorly documented benefit. The benefit-risk assessment should be carried out for all areas of use authorized in the EU.

The European Medicines Agency (EMA) limited both the duration of therapy and the dose for the use of MCP. So it is only a maximum of five days to be applied, which excludes the use in chronic diseases such as reflux disease, gastroparesis and dyspepsia. In addition, the drug should no longer be used in patients under the age of one year, as severe neurological side effects have been observed, especially in children. Unwanted complaints, which can also occur in adults, include restlessness, fatigue, dizziness and depression, headaches and movement disorders such as muscle spasms and tremors. MCP is suspected to be the most common trigger for drug-related movement disorders. In addition, the active ingredient may cause an increase in the level of prolactin, which may subsequently lead to menstrual disorders, reduced libido and impotence.

According to the EMA, MCP is generally only used as a second-line drug in paediatrics. In this case, a daily dose of no more than 0.5 mg of active ingredient per kilogram of body weight should not be exceeded. This dosage is also valid for adults, whereby the standard dose in the future should be three times 10 mg per day instead of four times 10 mg as before. According to the EMA, liquid oral metoclopramide-containing medicines would have to be restricted to 1 mg / ml of active ingredient content. (Ag)