FDA: King Forgot to Say Embeda Can Kill You; The Right Way to Take It? "Sprinkle on Apple Sauce"

That didn't take long: King Pharmaceuticals' Embeda painkiller was approved by the FDA in August and only became commercially available in September, and it's already received a warning letter for "especially egregious and alarming" marketing that minimizes the risk of fatality with the drug.

King had sent out a media backgrounder and video news release for Embeda, which is morphine sulfate and naltrexone. If morphine addicts attempt to crush or chew the pills, the naltrexone is released, rendering the drug useless.

The news release touted this quality but failed to mention that one of the risks of chewing the tablets is death from the potentially fatal dose of morphine within them, the FDA said:

... the video news releases completely omit the potential risk of fatality as described in the extensive Boxed Warning and WARNINGS AND PRECAUTIONS sections of the approved product labeling

The video news releases present limited information about the abuse potential of EMBEDA, yet make unsubstantiated claims regarding the reduction in abuse liability with EMBEDA. The omission ... is especially egregious and alarming in its potential impact on the public health.