Regulatory Focus™ > News Articles > Infamous Drug Focus of New FDA Enforcement Effort

Infamous Drug Focus of New FDA Enforcement Effort

Posted 27 November 2012 | By

The James Bond action movie "Skyfall" may be currently earning both accolades and hundreds of millions of dollars at the box office, but the US Food and Drug Administration (FDA) has a more practical concern regarding a drug that frequently makes an appearance in the spycraft-heavy series: cyanide.

The infamous drug is highly toxic to humans, and FDA notes that it is often fatal if an antidote is not immediately administered to the patient. Up until 2011, if you were unlucky enough to be poisoned with cyanide, you had precious few options to reverse the drug's effects. But in January 2011, FDA approved new two antidotes for the treatment of acute cyanide poisoning: Sodium Nitrate Injection/Sodium Thiosulfate and Sodium Thiosulfate Injection/Sodium Nitrate.

To anyone facing the effects the effects of cyanide poisoning-symptoms include coma, seizures, difficulty breathing and cardiac arrest-the antidotes are, quite literally, life-saving.

But even for those the antidote for whom the antidote is intended, it can cause potentially serious problems, FDA explains.  Two of the main ingredients found in the antidotes, sodium thiosulfate and sodium nitrate, can cause low blood pressure, and the latter can also decrease blood oxygen levels, causing damage to cardiac and neurological tissues. As a result, both approved antidote products carry boxed warnings under an approved Risk Evaluation and Mitigation Strategies (REMS) plan.

And some consumers-yes, the budding spies and the paranoid among us, but more commonly firefighters exposed to toxic smoke-may be more exposed to those risks than they think. In a 27 November Federal Register posting, FDA explained that the agency has become aware of "several unapproved drug products" containing the ingredients active in the two products it approved in 2011, as well as several other unapproved ones and in unapproved forms. Those products, FDA notes, have not been approved for safety or efficacy, and could very well be used in either inappropriate circumstances or without proper follow-up care.

In addition, those products could wind up harming consumers even if they are used in the proper situation and by a practicing physician. The drugs could be manufactured at the incorrect strength, have quality manufacturing problems or may have unsafe ingredients or additives.

FDA also took the step of reviewing all publicly available scientific literature to determine if the unapproved products were generally regarded as safe or effective (GRASE). "In no case did FDA find literature sufficient to support a determination that any of these [unapproved] drug products are GRASE," FDA wrote.

The agency said it now intends to take enforcement action against companies marketing the drugs and those that manufacture them, and "does not expect to issue a warning letter or any other further warning to firms marketing" the unapproved products.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.