Postmarketing Surveillance Data
Spontaneous Adverse Event Reports
- As of 8/12/98 sponsor had collected 968 postmarketing case reports of AEs due to Rx cyclobenzaprine
- 66 of the 968 were drug overdoses
- 186 of the remaining 902 were classified as serious in nature
- 51 were death reports
- 35 additional deaths in the FDA’s SRS data base