Attention – Supply shortage of ethambutol in Germany
Last week, a supply shortage of the drug Ethambutol (EMB) in 400 mg and 500 mg dosages affected patient care. Pharmacies are currently unable to order these preparations.
Some stocks of the 100 mg dosage are still available. However, therapy with this tablet form would mean taking an unacceptable number of tablets. For example, a person weighing 70 kg would have to take 17 tablets daily instead of 9 for the first two months of standard therapy. This massively increases the already high tablet burden for patients and is expected to lead to further supply shortages soon.
Since there is currently only one manufacturer of ethambutol in Germany, there are no alternative options available on the domestic market. Options for international import are currently being explored.
Background: EMB is an integral part of the standard therapy (alongside isoniazid, rifampicin, and pyrazinamide), which has been established since the 1970s. It is used during the two-month initial phase (intensive phase) before the regimen is reduced to isoniazid and rifampicin in the continuation phase. The initial four-drug regimen is primarily intended to prevent resistance. Due to the increased risk of resistance, triple therapy in the initial phase is generally not recommended by German guidelines.
Treatment of drug-sensitive tuberculosis without ethambutol
If ethambutol is not available for standard therapy in Germany, we recommend replacing the drug with a fluoroquinolone (2 months of rifampicin, isoniazid, pyrazinamide, and levofloxacin, followed by 4 months of rifampicin and isoniazid). CAUTION: ECG monitoring is required due to the potential for QT interval prolongation caused by levofloxacin.
If the disease is mild—for example, with low bacterial load in the sputum and unilateral infiltrates without cavities—ethambutol may be omitted from standard therapy after weighing individual risks (2 months of rifampicin, isoniazid, and pyrazinamide, followed by 4 months of rifampicin and isoniazid). A prerequisite is reliable evidence of the tuberculosis pathogen’s susceptibility to rifampicin, isoniazid, and pyrazinamide. Until the results of the susceptibility testing are available, treatment should be administered with 4 medications (rifampicin, isoniazid, pyrazinamide, and levofloxacin).
The criteria for assessing whether the disease is mild or severe have not yet been conclusively investigated scientifically. Therefore, the assessment must be made on a case-by-case basis, taking all available information into account. You can obtain advice to assist with this assessment by calling the information hotlines of the National Reference Center for Mycobacteria and Research Center Borstel (04537 1880) and the DZK (030 81490922). Additionally, the DZK website lists a network of clinics that treat drug-resistant tuberculosis and have qualified contact persons (www.dzk-tuberkulose.de).
Options for Importing Ethambutol
Ifethambutol is not available on the German market, it can be imported from countries such as Austria, Switzerland (where the package insert is usually in German), or France. According to information from a hospital pharmacy, delivery can take 10–15 days.
According to information from the Federal Institute for Drugs and Medical Devices (BfArM), a report of a supply shortage may serve as the basis for authorizing an individual import under Section 73(3) of the German Medicines Act (AMG). An import is therefore permitted if the medicinal product is not available in Germany and it is not possible to order it through parallel importation. Listing on PharmNet.Bund serves as evidence that a supply shortage exists at the manufacturer level.
You can find detailed information about the pharmacy procedure here >>
For more information, visit:
S2k guidelines for Germany, Austria, Switzerland
