FDA Drug Safety Communication: Zofran

Tweet

Note: Many CentreLearn lessons for advanced providers advise administration of an anti-emetic, based on local protocols, for patients with nausea and vomiting. After the FDA issued a Drug Safety Communication on September 15, 2011, I asked Ada County Paramedic R. Steve Cole for his thoughts on how this warning will impact EMS usage of Zofran. Steve responds below.

This is a good question; I think it is important to look at the recent history of anti emetics in American EMS.

1. For decades Phenergan was the primary anti-emetic and probably one of the earliest anti-emetics used in EMS. As you know, Phenergan has some issues with discomfort on administration and over-sedation. Rarely, Extra-Pyramidal Symptoms (EPS) and EPS-related symptoms present. This did not deter its use however, as there were no other readily available options, and most advanced providers knew how to properly administer and monitor for side effects.

2. While Inapsine has been around since the early '60s , it took several decades for it to make it out of the operating room and hospital environment to EMS (mid '80s). It was believed to be safe, effective, and easier on the patient. There was less sedation and no risk of EPS, tissue necrosis, or sedation. However, in 2001 the FDA issued its strongest class of warning, a "Black Box" warning. For many observers, the basis of this warning was questioned by many healthcare providers as not being based on sound principles of evidence based medicine. Ironically, Zofran carried many of the same warnings and precautions that got Inapsine the Black Box Warning.

3. As a result of the black box warning, many EMS systems returned to Phenegan as Zofran was still on patent and significantly more expensive. Phenergan has issues however. The above mentioned patient discomfort, sedation, and necrosis risk being the most significant. Later, when the FDA announced a warning for sedation and use of Phenergan in pediatrics, many EMS services transitioned (yet again) to another anti-emetic...Zofran. The fact that Zofran had since become "generic", brining the cost down significantly, made this easier to swallow.

So here we are, and it seems like deja vu doesn't it? While the parallels to this and Inapsine are striking, there are some fundamental differences.

1.This is not a Black Box warning. It is a refinement of warnings that already exist. Warnings that were already in place when many EMS agencies transitioned to Zofran.

2. There are very few alternative anti-emetics suitable for EMS. Even fewer that do not have the same warnings as Zofran and Inapsine, and none (that I am aware of) that are as inexpensive or available as a generic. Also, Zofran is available as an oral desolvable tablet (ODT) , and has an established record in pediatrics that most other anti-emetics do not have.

To review, the contenders for the anti-emetic crown in EMS are:

• Scapolamine? Too many problems with abuse, sedation, interaction with opioids, and side effects. 
• Reglan? Similar to Phenergan, sedation is a issue, as are EPS, and allergic reactions. 
• Anzemet? Not a good option for EMS. It takes too long to take effect and dosing is difficult. 

So, in summary, I don't see a mass exodus away from Zofran because there are no suitable alternatives. Sure, some agencies may return to Phenergan or try to use Benadryl or some may use Compazine. Others may make EKG monitoring mandatory on all patients receiving Zofran, but overall I think we (medicine in general) are a little skeptical of these warnings now and take them with a grain of salt.

Now if a suitable, affordable option that was good for EMS presented itself, or if this was a black box warning, then this would be a different story.