Harvoni tablets Beware of circulating fake pills from the pharmacy

This can be dangerous: The Federal Institute for Drugs and Medical Devices (BfArM) warns against counterfeit medicines used for the treatment of chronic hepatitis C. Often, the ingredients and compositions of fake tablets are different than the originals. At present this is still under investigation, so the institute.

The BfArM warns of a falsification of the drug Hareadi® 90 mg / 400 mg film-coated tablets from Gilead, which has come on the German market and was discovered in a pharmacy in North Rhine-Westphalia. The drug regularly contains the active ingredient combination ledipasvir and sofosbuvir and is used in adults for the treatment of chronic hepatitis C (CHC).

(Image: Gina Sanders / fotolia.com)

The counterfeit tablets are not orange as usual, but white. The packs bear the batch designation 16SFC021D (expiry date 06/2018), which is a real existing batch for the German market. The counterfeit tablets differ from the original only in the white color. The packaging of the tablets as well as the tablet shape and embossing correspond to the original. The forgery was discovered by a patient in North Rhine-Westphalia, who reported it to his pharmacy.

The origin of the counterfeit and the contents of the tablets are currently under investigation. Therefore, it is not yet known to the BfArM which substances contain the different-looking tablets and whether there are any health risks associated with ingestion.

Patients taking Gilead's product Harvoni® 90 mg / 400 mg film-coated tablets and finding that they are white tablets should never take them or consult their doctor or pharmacist for further action denied. 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, in the event of counterfeiting, to follow the usual reporting procedures.

The BfArM is in close contact with the state authorities, which are responsible for the monitoring of drug traffic in Germany, as well as with the European Medicines Agency (EMA). As soon as further information is available, the BfArM will inform immediately. (Sb)