FDA panel backs Dynavax’s hep B vaccine efficacy, not safety

(Reuters) – A U.S. Food and Drug Administration panel voted unanimously to recommend the effectiveness of Dynavax Inc’s hepatitis B vaccine Heplisav, but raised concerns about its safety, asking for more data from studies on a wider population. The views of the panel of outside experts were based on data submitted by Dynavax that compared the safety and immunogenicity, or ability to evoke an immune response, of its Heplisav with that of an older vaccine named Engerix B by GlaxoSmithKline Plc. …

5-Hour Energy Drinks Suspected in Deaths, Heart Attacks, Convulsions

The Atlantic Wire reports 5-Hour Energy Drinks are linked with 13 deaths in the past four years. The drinks are also the subject of 90 Food and Drug Administration complaints, including 30 involving life-threatening medical conditions. The medical conditions cited in the filings as possibly caused by the drinks include heart attacks, convulsions, and in one case, a spontaneous abortion, the Atlantic Wire said.

Ireland to clarify abortion rules after woman’s death

Savita Halappanavar is seen in an undated family photo in Galway, IrelandDUBLIN (Reuters) – Ireland's government pledged on Thursday to clarify its abortion laws after an Indian woman who was refused a termination died from blood poisoning in an Irish hospital. Thousands took to the streets to protest on Wednesday after news broke of the death of Savita Halappanavar of septicemia following a miscarriage 17 weeks into her pregnancy. Activists in the overwhelmingly Roman Catholic country, which has some of the world's most restrictive laws on abortion, say the refusal by doctors to terminate the pregnancy earlier may have contributed to her death. …

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