FDA officially reject's Merck's Bridion—again
- Merck's Bridion (sugammadex), which is intended to reverse the effects of muscle relaxants used in surgery, has been rejected by the FDA for a third time.
- The agency has requested more information and data related to the "hypersensitivity" to the drug.
- Bridion is already approved and marketed in more than 60 countries.
Apparently, the third time was not the charm in this case. Case studies have shown that Bridion-relatd allergeic reactions can occur suddenly and with varying degrees of severity. In one report, detailing allergic reaction to Bridion, allergic reactions developed within three minutes in two patients. In general, Bridion-related allergic reactions include flushing, tachycardia and rash; however, the FDA is most concerned about hypersensitive reactions that could potentially lead to anaphylaxis.
Because Bridion is already widely used in Europe, there are numerous reports detailing allerrgic reactions. More data from Merck is needed before the FDA will consider approval of Bridion in the U.S.