Serious adverse events reporting

The most frequently reported serious adverse events reported with cancer chemotherapy patients included death, fever, pneumonia, dehydration, vomiting, and dyspnea. The most commonly reported adverse events were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea. The most frequently reported reasons for discontinuation of darbepoetin alfa were progressive disease, death, discontinuation of the chemotherapy, asthenia, dyspnea, pneumonia, Gl hemorrhage, thrombotic events, rash, dehydration. 

When the individual isomers are given separately, the apparent oral clearance of the (-)-enantiomer is >10 times that of the (+)-enan-tiomer. Losigamone is eliminated primarily by oxidation. Biotransformation is stereoselective, with the (-)-enantiomer undergoing greater first-pass metabolism compared to that of the other isomer. It has undergone one clinical trial with no serious adverse events reported (226). 

No serious adverse events reported to date have been deemed related to rAHE-PEM. 

Of the non-serious adverse events reported, seven have been deemed related to rAHF-PFM (four moderate, one mild, and two severe events which consisted of decreased coagulation FVIII level and unspecified hematoma). 

In terms of efficacy, data such as the number of infusions needed and treatment outcome rAHF-PFM were effective in preventing and controlling bleedings in patients with severe hemophilia A. In safety and immunogenicity studies, no serious adverse events reported to date have been deemed related to rAHF-PFM. The incidence rates for the most common non-serious adverse events indicate that drag-related adverse events were similar or even lower in number and in nature to those observed in chnical trials with other rFVlll concentrates. To date, no inhibitors have been reported. The first rAHF, Recombinate, was developed by Baxter and became commercially available in 1992. Its long record of efficacy and safety has made Recombinate the standard for care in hemophiha A therapy [9-11]. rAHF-PFM, Advate , received market authorization in 2003 in the US and in 2004 in Europe. 

Blue cohosh has been used to augment labor and also for up to several weeks prior to the due date as a parturifacient (Felter and Lloyd 1898) and was officially listed as a labor inducer in the U.S. Pharmacopoeia from 1882-1905. There have been a small number of serious adverse events reported in infants born to mothers taking blue cohosh several weeks prior to birth. A 1999 survey of nurse midwives found that 64% used blue cohosh, often in combination with black cohosh, to augment labor during delivery. This survey noted that blue cohosh is the herb midwives... 

Systematic reviews of several dozen clinical trials (all subcutaneous injections of 1 to 200 mg) indicated that European mistletoe is generally very well tolerated, with no serious adverse events reported. Minor localized reactions at the injection site are sometimes associated with injections of European mistletoe, but such effects are not expected after oral use (Horneber et al. 2009 Kienle et al. 2009 Stein and Berg 2000). 

Observational studies In October 2003 the Advisory Committee on Immunization Practices (ACIP) recommended influenza immunization for all children aged 6-23 months [30 ]. The safety of this recommendation has been evaluated using the Vaccine Adverse Event Reporting System (VAERS) to study serious adverse events reported between 1 July 2003 and 30 June 2006 in children aged 6-23 months who had been given trivalent inactivated influenza vaccine. There were 104 serious adverse events at a median time after immunization of 1 day. The two most common serious adverse events were fever (52 reports) and seizures (35 reports). Causality assessment suggested that none was definitely related to influenza vaccine. No new or unexpected concerns were identified. 

---