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This can be dangerous: the Federal Institute for Drugs and Medical Devices (BfArM) warns of counterfeit drugs that are used to treat chronic hepatitis C. The ingredients and compositions of facet tablets are often different from those of the originals. At the moment this is still being investigated, according to the institute.
The BfArM warns against counterfeiting of the drug Harvoni® 90 mg / 400 mg film-coated tablets by Gilead, which has entered the German market and was discovered in a pharmacy in North Rhine-Westphalia. The medicine contains the active ingredient combination ledipasvir and sofosbuvir and is used in adults to treat chronic hepatitis C (CHC).
The counterfeit tablets are not orange as usual, but white. The packs have the batch number 16SFC021D (expiry date 06/2018), which is a real batch for the German market. The fake tablets differ from the original only in the white color. The packaging of the tablets as well as the shape and shape of the tablets correspond to the original. The counterfeit was discovered by a patient in North Rhine-Westphalia who reported it to his pharmacy.
The origin of the counterfeit and the content of the tablets are currently being investigated. The BfArM is therefore not yet aware of what substances the different-looking tablets contain and whether there are health risks associated with taking them.
Patients who take the drug Harvoni® 90 mg / 400 mg film-coated tablets from Gilead and find that they are white tablets should not take them under any circumstances and should contact their doctor or pharmacist for further action to coordinate. The BfArM points out that a medical prescription must be presented to the pharmacy for the exchange.
Pharmacists are advised to check the color of the film-coated tablets and to follow the usual reporting channels in the event of a counterfeit.
The BfArM is in close contact with the state authorities responsible for monitoring medicines in Germany and with the European Medicines Agency (EMA). As soon as further information is available, the BfArM will inform you immediately. (sb)