EMA\u2019s human medicines committee (CHMP) has finalised its review of medicines containing ipidacrine, which are used in adults to treat different conditions affecting the nervous system.<\/p>\n
The Committee recommended restricting and better defining the approved uses of the medicines. The medicines can now only be used to relieve symptoms of specific conditions\u00a0leading to nerve damage in one or more nerves (mononeuropathies and polyneuropathies), but no longer for neuritis, polyneuritis, polyradiculoneuropathy and myasthenic syndrome. They can also be used for the symptomatic treatment of Alzheimer’s disease and intestinal atony (a lack of muscle contraction in the gut, resulting in problems with its movement), as an additional symptomatic treatment in certain patients recovering from stroke or traumatic brain injury, and in patients with myasthenia gravis (a disease that causes muscle weakness).\u00a0<\/p>\n
In addition, the Committee recommended that the medicines should no longer be used to treat demyelinating diseases, which are conditions that damage the protective covering around nerves.<\/p>\n
The review found that the currently authorised uses were not well defined. Many of the available studies in people with these conditions included only a small number of patients, did not compare ipidacrine with another treatment or placebo (a dummy treatment), or were conducted in a way that could have influenced the results. In some cases, standard of care had changed and no longer supported the use of ipidacrine for these types of disease.<\/p>\n
Therefore, the Committee recommended revising approved uses of ipidacrine to align them with the available data and the current standards of care.<\/p>\n
The CHMP also recommended that ipidacrine medicines should only be prescribed by doctors experienced in diagnosing and treating these conditions.<\/p>\n
Based on the available safety data, the Committee did not identify any new safety concerns. However, there is an increased risk of side effects at high doses and a risk of liver toxicity cannot be excluded.\u00a0Therefore,\u00a0caution is recommended when using the medicine at doses greater than 80 mg per day\u00a0and in patients who have or have had abnormal liver function in the past.\u00a0<\/p>\n
The full list of revised uses can be found in the\u00a0published\u00a0product information.<\/p>\n
Information for patients<\/p>\n
Following its review, the CHMP recommended changes to the authorised uses of ipidacrine-containing medicines\u00a0which should now only be used to treat symptoms of specific conditions affecting the nervous system, Alzheimer’s disease and intestinal atony, as well as additional symptomatic treatment in certain patients recovering from stroke or traumatic brain injury and in patients with myasthenia gravis.
\nThe Committee recommended that the medicine should no longer be used for neuritis (inflammation of the nerves), polyneuritis (inflammation of multiple nerves), polyradiculoneuropathy\u00a0(an inflammatory condition affecting the peripheral nerves and roots of the spinal nerves), myasthenic syndrome (a group of conditions causing muscle weakness) or\u00a0demyelinating diseases (conditions that cause the breakdown of the protective covering around nerves).
\nThere is an increased risk of side effects at high doses of ipidacrine and a risk of liver toxicity cannot be excluded.\u00a0Therefore, caution is recommended when ipidacrine is used at daily doses greater than 80 mg and in patients who have or have had liver problems.
\nIf you are taking ipidacrine for\u00a0neuritis, polyneuritis, polyradiculoneuropathy, myasthenic syndrome or\u00a0demyelinating diseases, have been prescribed a daily dose above 80 mg or have liver disease, you should contact your doctor.
\nDosing recommendations for some uses have been revised and your doctor will take these into account when prescribing the medicine to you.
\nIf you are taking ipidacrine and have any questions, you should speak to your doctor or pharmacist.<\/p>\n
Information for healthcare professionals<\/p>\n
Following its review, the CHMP recommended changes to the authorised uses of ipidacrine-containing medicines to better reflect the available evidence and current clinical practice. The changes provide greater clarity on the conditions and patient populations for which the medicines can be used.
\nThe recommendations are as follows:
\nThe current use in peripheral nervous system diseases (neuritis, polyneuritis, polyneuropathy, polyradiculoneuropathy, myasthenia and myasthenic syndrome of various aetiologies) has been restricted to symptomatic treatment of acquired mononeuropathies and polyneuropathies and adjunctive symptomatic treatment of myasthenia gravis.
\nThe current use for bulbar palsy and paresis has been restricted to adjunctive symptomatic treatment of bulbar dysfunction during the recovery period following ischaemic stroke affecting the brainstem.
\nThe current use for organic central nervous system lesions with movement disorders during the recovery period has been restricted to adjunctive symptomatic treatment of motor impairment during the recovery period following ischaemic or haemorrhagic stroke or traumatic brain injury.
\nThe current use for memory disorders of various origins (Alzheimer\u2019s disease and other types of senile dementia) has been restricted to symptomatic treatment of mild to moderately severe Alzheimer\u2019s disease with or without vascular dementia.
\nThe current use for intestinal atony has been restricted to symptomatic treatment of intestinal atony.
\nThe current use for demyelinating diseases has been removed.
\nIpidacrine should no longer be used for neuritis, polyneuritis, polyradiculoneuropathy, myasthenic syndrome of various aetiologies and\u00a0demyelinating diseases\u00a0because the data were too limited to support the benefits, and\u00a0standards of care had changed and no longer supported these uses of ipidacrine.
\nIpidacrine should only be prescribed\u00a0by doctors experienced in diagnosing and treating these conditions.
\nDosing recommendations for some indications have been revised, and prescribers should consult the revised product information for further details.
\nThere is an increased risk of side effects\u00a0at high doses of ipidacrine and a risk of liver toxicity cannot be excluded.\u00a0Therefore,\u00a0caution is recommended when using the medicine at doses greater than 80 mg per day\u00a0and in patients who have or have had abnormal liver function in the past.<\/p>\n
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More about the medicine<\/p>\n
In the EU, ipidacrine-containing medicines are used in adults to treat several conditions affecting the nervous system. These include:\u00a0<\/p>\n
diseases affecting the peripheral nervous system (the part of the nervous system outside of the brain and spinal cord) such as neuritis (inflammation of the nerves), polyneuritis (inflammation of multiple nerves), polyneuropathy (damage affecting multiple nerves), polyradiculoneuropathy (an inflammatory condition affecting the peripheral nerves and roots of the spinal nerves), myasthenia gravis (a disease that causes muscle weakness), and myasthenic syndrome (a group of conditions causing muscle weakness).
\nbulbar palsy and paresis (disorders affecting the nerves that control speech and swallowing);
\ndemyelinating conditions (conditions that cause the breakdown of the protective covering around nerves) together with other therapies;
\nmemory disorders due to different causes including Alzheimer\u2019s disease and senile dementia (decline in mental abilities that occurs in older age);
\nintestinal atony (a lack of muscle contraction in the gut, resulting in problems with its movement);
\nadults recovering from central nervous system lesions (damage to the tissue of the brain or spinal cord) that cause movement disorders.<\/p>\n
Ipidacrine-containing medicines are authorised in a number of EU countries including Austria, Bulgaria, Croatia, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Romania, Slovakia and Slovenia. They have been used in some of these countries since 1997 and are available as tablets taken by mouth or as an injection given into a muscle or under the skin.<\/p>\n
They are available under a range of trade names including Ipidacrine Grindeks, Ipidacrine Hydrochloride Grindeks, Ipigriks, Ipigrix and Neiromidin.<\/p>\n
More about the procedure<\/p>\n