More cases of fake Botox, Viread discovered

The US FDA has uncovered another case of counterfeit Botox in the supply chain, while a fake of Gilead's HIV drug Viread has been found in Germany.

The counterfeit Botox products - which were sold by an unlicensed supplier and may have found its way into doctors' offices and medical clinics nationwide - "are considered unsafe and should not be used," said the US regulator.

The FDA says health practitioners should check with Allergan - the manufacturer of legitimate Botox (onabotulinumtoxinA) - to make sure that the distributor they purchase supplies from is authorised to distribute the products, which is used to treat wrinkles and certain medical conditions.

Last year, a report produced by the Physicians Coalition for Injectable Safety (PCIS) and Partnership for Safe Medicines (PSM) suggested that illicit injectable cosmetic treatments have spread right across the US in recent years.

The FDA has issued a number of warnings of counterfeit Botox, including public advisories in 2012 and 2013 and upwards of 45 individuals prosecuted for the purchase or sale of counterfeit Botox or other injectable cosmetics between 2005 and 2013.

Both the outer carton and vial on the suspect product are counterfeit, according to the FDA, which says the fakes can be identified by one or more of the following:

- the vial is missing the lot number;
- the outer carton does not have any entries next to the LOT: MFG: EXP; and
- the outer carton and vial display the active ingredient as 'Botulinum Toxin Type A' instead of 'OnabotulinumtoxinA'.

"FDA is not aware of any adverse events associated with the counterfeit version of Botox at this time," said the agency.

Viread re-imports

In the case of Viread, German importers Medicopharm and Axicorp have issued a recall of one batch of Viread (tenofovir) after irregularities were seen on the product's packaging. On analysis the batch - with the number 13VR029D - was found to consist of counterfeit film-coated tablets in genuine sealed packaging.

In 2011, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK confirmed that counterfeit versions of Viread had been discovered on the UK market.