metoclopramide

17 April 2009

FDA Warning: Reglan (Metoclopramide)

On the 26th of February 2009, the FDA issued a warning about metoclopramide, commonly sold under the brand name of Reglan, as well as many others (Clopra, Maxolon, Reclomide, and Octamide). The warning is for patients taking high doses, or taking it over the long term.

Reglan is commonly used for migraine, particularly migraine in children, because of its ability to treat both nausea and pain. It also is given along side other migraine medications, because it can help them absorb better.

It is an antiemetic and gastrointestinal stimulant, and is also prescribed for things like gastroesophageal reflux disease (GERD), stomach ulcer, and even to increase milk production in nursing mothers.

The FDA warning says that too much metoclopramide can cause tardive dyskinesia, which causes patients to make involuntary, repetitive, purposeless motions. This has actually been known for some time, and there are other drugs that cause the same thing. However, according to the FDA press release, a recent analysis has suggested that metoclopramide is the most common cause. The symptoms often go away several weeks after the medication is stopped, but not always. The effect can be permanent.

The concern is especially with patients who are taking metoclopramide for more than three months. If you’re taking an unusually high dosage, or are taking the medication regularly over a long period of time, be sure you know the risks.

The concerns about Reglan are just a reminder that many drugs that are fairly safe for a short period of time can cause problems over a longer period. More is not always better. Be sure to know the risks, and take your medication only as directed by a doctor who understands your medical history and knows what other medication you’re taking.

via Somebody Heal Me

1 December 2005

MT 100 coming to the UK

James Medications, News 0

MT 100, an oral migraine drug from Pozen, was been approved in the UK on Monday (28 Nov). The drug contains naproxen sodium and metoclopramide. Naproxen sodium is familiar to migraineurs, it reduces pain and inflammation, and is often used for migraine brought on by hormonal changes. Metoclopramide has been used to reduce pain and decrease nausea (it’s worked well for children with migraine). It also enhances the effect of naproxen sodium by accelerating it’s absorption.

Pozen gave up on MT 100 in the USA when the FDA expressed concerns that it may cause tardive dyskinesia, a rare disorder of the nervous system. Pozen argues that the drug is meant to be used intermittently, so the danger is minimal.

Pozen will be looking for distributors for the UK and various other countries.

6 August 2005

One new drug set aside, another on the way…

James Medications, News 1

Pozen, Inc. has decided to stop developing its new migraine drug, MT 100. The Naproxen Sodium and Metoclopramide Hydrochloride drug needed more trials, the FDA concluded. There have been concerns that it may cause tardive dyskinesia, a chronic disorder of the nervous system causing jerky movements in the face, tongue, and other parts of the body.

However, yesterday Pozen announced it was going to focus on another new drug, Trexima. Trexima is a combination of sumatriptan (formulated with "RT Technology") and naproxen sodium. So far the trials are going well, and Pozen is hoping to make the drug available as soon as possible. The ingredient in MT 100 that was causing concern, metoclopramide, is not present in Trexima. Sumatriptan and naproxen sodium are familiar to migraineurs. RT technology has been used with Imitrex – it allows the drug to dissolve very quickly after swallowing, getting it into the body where it’s needed much faster.