|Counterfeit diazepam--Courtesy FDA|
Hundreds of adverse reactions and dozens of hospitalizations tied to counterfeit diazepam in Africa have the FDA concerned enough that it is warning consumers to check their meds carefully if they bought the generic form of Valium online.
The FDA said Monday that more than 700 adverse reactions have been reported by the World Health Organization (WHO) in Central Africa of patients who took medication that was marked diazepam but which lab testing showed contained instead the active ingredient, haloperidol, an antipsychotic. The patients who mistakenly took haloperidol suffered acute contractions of the muscles in the face, neck and tongue (dystonia), some lasting several days. At least 40 were hospitalized.
The WHO says the drugs are scored with the name AGOG and came in 1,000 tablets marked with the trade name SOLINA and "Diazepam Tablets BP 5 mg" manufactured by CENTAUR Pharmaceuticals.
The WHO says Agog Pharma manufactures haloperidol but not diazepam and packages its haloperidol in blister packs of 10 tablets each. Centaur manufacturers haloperidol but not diazepam, WHO reported, and claims they did not manufacture the products tied to the reactions.
The FDA acknowledged that it does not know if the drugs are being sold online, and has no reports that they have been seen in the U.S. But the FDA knows how the counterfeit drug industry works, and realizes it is possible for the drugs to be available over the Internet. WHO has estimated that half of the drugs sold online are fakes. The FDA has seized diazepam that was sold illegally online and in 2010 arrested a man who was selling fake Valium that was manufactured in China.
Fakes of more sophisticated, injectable drugs have found their way into the U.S. as well. In May, the FDA warned doctors' practices that it had discovered new supplies of counterfeit Botox in the U.S. and that the agency believed it was unsafe. Counterfeit Botox was also discovered in the U.S. in 2012.