New marketing authorizations for metoclopramide drops will be granted again starting in August 2015. They will be available again in pharmacies at a concentration of 1 mg/ml, with a revised indication and duration of therapy. The 1 mg/ml metoclopramide solution is approved for adults for the treatment of nausea and vomiting (as an antiemetic) associated with chemotherapy, as well as for the prevention of these symptoms caused by radiation therapy or acute migraine.
Unlike before, the active ingredient concentration is now only a quarter. Therefore, dosing is no longer done with a dropper, but with a graduated pipette. It contains 5 ml, the recommended single dose for adults; two full pipettes are needed for 10 mg. The medication is intended to be reimbursable.
Five further marketing authorization applications for MCP in the concentration of 1 mg/ml and the dosage form "oral solution" are still pending at the Federal Institute for Drugs and Medical Devices (BfArM).
Background: Many migraine patients were able to effectively and well-toleratedly treat nausea and vomiting with metoclopramide (MCP), and also improve gastric motility. However, in April 2014, the marketing authorizations for all metoclopramide-containing oral drops with a concentration higher than 1 mg/ml were revoked. These products were withdrawn from the market. As a consequence of the revocation, all indications for chronic migraine symptoms were no longer valid. This came as a surprise to many migraine patients, and other options were often ineffective or poorly tolerated.
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 were no longer marketable and were recalled. All preparations available in Germany contained concentrations between 4 and 5 mg/ml and were therefore 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.
The newly approved metoclopramide drops, effective August 2015, now have a lower concentration of 1 mg/ml. The maximum dosage for adults is now 30 mg or 0.5 mg/kg body weight per day. For children, the dosage is based on body weight. A dose of 0.1 to 0.15 mg/kg body weight up to three times daily is recommended. The maximum 24-hour dose for children is also 0.5 mg/kg body weight. The duration of therapy has been limited to a maximum of five days. All indications for chronic symptoms have been removed as a result of the revocation of the previous marketing authorizations.
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.
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.
I suffer from positional vertigo, so I have to do so-called repositioning maneuvers to get rid of it! With every exercise, I vomit my guts out; only Paspertin helped me, without it, no exercise was possible
This medication has always worked wonders for me. Never had any side effects. Since it's unfortunately not as effective as it used to be, I'm now taking four to five times the dose. Now it works again. Everything's fine. It's just a shame it's more expensive. Has anyone ever wondered why the pharmaceutical industry lets the approval for an important drug expire? The end wasn't exactly a surprise
It's good that an essential medication is available again. Unfortunately, the new package sizes only allow for a three-day course of treatment for adults. That's not very practical when dealing with a full-blown gastrointestinal virus.
Metoclopramide (MCP) has always been the first-line treatment. Anyone who isn't plagued by migraines or dealing with the side effects of chemotherapy can't possibly appreciate how important this medication is, regardless of the dosage! In those cases, you'd simply take more to achieve the same effect for the patient.
I was so relieved when I heard the drops had been withdrawn from the market. In 2012, I took seven drops twice a day for several days because of stomach pain. What happened to me afterward was much, much worse than the stomach pain. I had extreme motor disturbances. It was as if a force was pulling me downwards and I was lying on the floor. When I tried to get into the car, I was "pulled" down next to the car door. For three weeks after that, I only took the train to work. When I sat down, I was "pulled" to the side, as if I were sitting in a plane during takeoff. My colleagues were shocked. I wasn't dizzy, nor did it feel like low blood pressure. On every day I took these drops, I had these "attacks." It was awful. I would never, ever take MCP drops again. I don't know how it is with the current version, but I only took seven drops and had these extreme side effects.
Ingrid Brieden
Many doctors say MCP causes psychosis. What nonsense!!!
If someone is taking MCP and already has a psychosis, that's understandable!
MCP is a very good medication!!!
What Sarina is writing here is nonsense, since logically you always have to assume that you'll experience side effects with an overdose, and that has nothing to do with the concentration of the active ingredient! Anyone who can read the package insert is clearly at an advantage.
Taking these drops off the market was, in my opinion, the worst decision that could have been made, as it was the only medication that truly delivered on its promises, and for me, without any side effects whatsoever!
ADDENDUM: I took this medication myself for almost 5 years until the recall.
Since it's been back on the market, I've been taking it again. In the meantime, I didn't have to go without it; I had stockpiled it in time and ended up with tablets (10mg) from an acquaintance. He told me the tablets were still available as usual, only the drops were affected. Before I could check with my doctor, however, the drops were re-approved, and the problem was thus resolved (1mg/ml instead of 4mg/ml).
Sincerely, Dask
I accidentally overdosed on the MCP drops once, and based on this very frightening and unpleasant experience, I can only say that the adjustment of the active ingredient concentration should have been made earlier.
Both pharmaceutical companies and regulatory authorities are playing with the suffering of seriously ill patients quite recklessly. Because only they were severely affected by the ban. Someone who occasionally took metoclopramide (MCP) for bloating certainly didn't miss the medication. For others, the consequences were dramatic! How presumptuous everyone is making these decisions, leaving those truly tragically affected defenseless! Commissions must be established for such matters, with representatives from those affected, to weigh the options and decide whether, for example, such an important medication should be restricted to general practitioners only.
Finally!!!!!!