We think that an explanation for these unusual deaths -- only one per , cases with this unusual organism -- may be the vaginal self-administration of misoprostol under unusual circumstances. That might answer the very good question of why California, why not in Europe. The only other known infection death involving the drugs occurred during a clinical trial in Canada in None of the European cases is believed to have been caused by infection, he said, adding that half of abortions in Scotland and one third of early abortions in France are done with the drug combination.
Lynn Bryant, whose otherwise healthy daughter Chanelle died in , said that it is imperative for doctors, nurses and emergency room staff to know about the potential for serious side effects and death. In addition, the women who had Clostridium sordellii did not run a fever, a normal side effect of an infection, according to the FDA. I feel the drug is not safe. There are problems. I feel a lot of these problems have not been reported. Reporting deaths and side effects of the drug is voluntary for doctors, although it is a requirement for drug makers.
Opponents of the drug believe that doctors are loath to report bad outcomes in abortion cases, making the number of problems far greater than the public knows. Part of the investigation is a search for other deaths and additional ill effects from the drug combination. The nonsurgical abortion drug has been controversial since it was created by French researchers a generation ago. The Food and Drug Administration recently launched an investigation into the drug regimen.
Its generic name is mifepristone. Two months later, Danco Laboratories begins distribution of the drug under the brand name Mifeprex. Kahlenborn, MD et al. EC and Mifeprex are completely different drugs.
EC helps to prevent pregnancy, while Mifeprex terminates an early pregnancy" "Fact Sheet," supra. But, as noted, EC may also terminate an early pregnancy. And mifepristone has been used both as EC and tested as an alternative to daily contra-ceptives.
And they're all used to kill young humans. The common side effects of EC are nausea, abdominal pain, fatigue, headache, dizziness, breast tenderness, vomiting, diarrhea, and bleeding. The Preven "Prescribing Information" warns: "Blood clots that form in the leg can cause blockage of blood flow in the leg veins [and] can travel to the lung, causing serious disability or death" www. Risks are greatly increased for women who smoke.
But you won't find that in a boxed "Surgeon General's warning" on their ads. On a pro-choice, post-abortion support message board where women discuss their experiences using EC, one finds reactions like these: "I thought I was never going to stop throwing up"; "Yuck, yuck, yuck.
I was sick for three days"; "I'm sick. I'm sore. I'm a complete emotional wreck. I'm scared"; "i feel so many things, all so conflicting, and i have so much fear and self-loathing"; and, "FOR ME the morning-after pill was a totally negative experience which left me with lots of self-blame, unanswered questions, mistrust in doctors" www. EC has been readily accessible to women in Scotland for years, but abortions increased among every age group between and Teen pregnancy and abortion rates have not fallen.
The logic that dictates EC use will result in fewer abortions rests on an assumption that increased access to EC will not increase promiscuity. This is very susceptible to antibiotic treatment. So it would seem that it's possible if antibiotic treatment had been introduced early for this woman then it might have made some difference but I really can't say that. CAROLINE DE COSTA: If you are going to have the woman undergoing the abortion processes at home, which has certainly been done in overseas studies and we have been doing it in Cairns, then you must have very close contact with her and you must, she must know and you must know what arrangements are in place if she should need emergency care or extra care.
That must be in place. And there are guidelines from the Royal College of Obstetricians and Gynaecologists in London which recommend using antibiotics prophylactically for all women or at least considering this when you're practising early medical abortion.
And you'd certainly want the woman well informed that if she did develop a temperature she should immediately be in touch either with the clinic that was looking after her or with a designated hospital or doctor or emergency service. Professor De Costa says she accepts that decision. I think we have to be very clear that if we're going to continue using the drug for early medical abortion and using it at home then services have very, very good mechanisms in place for looking after women once they actually leave the clinic.
Nor has the FDA confirmed the cause of the latest two deaths. Those women did not follow FDA-approved instructions for the pill-triggered abortion, which requires swallowing three tablets of one drug, followed by two of another two days later. That use does not have federal approval, although studies have indicated it produces fewer side effects.
It was not immediately known whether the second course of pills had been inserted vaginally in the two latest women to die, an FDA spokeswoman said.
She declined to be identified, saying she was not authorized to speak publicly about the issue. Monty Patterson, a California man whose year-old daughter, Holly, died in after taking the abortion pill, also said the drug should be pulled.
0コメント