Guest guest Posted April 10, 2006 Report Share Posted April 10, 2006 Thanks Meena for that comprehensive article on Mifepristone and Misoprostol. However, as Anchita has emphasized before, the safety of the drug far outweighs the rare complications. So let us take care, but not panic. Remember that the case study states that only 4 cases of septicemia were reported. I personally do over 50 cases of abortion with this combination every month. I do not use any prophylactic antibiotic. The only complications that I have noted are Excessive bleeding, prolonged bleeding and failure of abortion. In a majority of patients, a prior counselling avoids panic for the first two complications. Sometimes a repeat dose of Misoprostol also helps. The third complication is rare and I always perform a Suction Curretage, instead of repeating tablets. The patient does not crib when I tell her that I shall not charge her a single paisa for this failed abortion. Rate of failure is just about 1 in a 100 cases. It helps that I have an USG machine in my OPD. That way I can routinely screen all my patients for completeness of abortion. Kishore Shah 1974 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 10, 2006 Report Share Posted April 10, 2006 Difficult to blame infection on Mifepristone. It would more be related to the abortion process. Like many drugs we use ---- not all are approved/licensed for use. We still use them...... With regards L/M Prasad (lp1960@...) Wish a very happy and cheerful day keep smiling > abortion drug > > > > Medscape Alert > Abortion Drug Mifeprex Linked to 2 More Deaths > > Yael Waknine > --> > March 17, 2006 — The US Food and Drug Administration (FDA) > has notified healthcare professionals of 2 additional deaths > after medical abortion with mifepristone (Mifeprex 200-mg > tablets, made by Danco Laboratories, LLC), according to an > alert sent today from MedWatch, the FDA's safety information > and adverse event reporting program. > > After verbal notification of the deaths by the manufacturer, > an FDA investigation was launched into their circumstances. > Although use of mifepristone was previously linked to 4 > deaths from Clostridium sordellii-associated sepsis, the > causes of death for the present cases remain unconfirmed. > > Abortion providers and patients are reminded to consider the > specific circumstances and directions for use of mifepristone > prior to initiating therapy. Potential adverse events such as > sepsis should also be discussed, and patients warned of early > signs and symptoms that may require immediate medical > evaluation, such as fever, abdominal pain, and heavy bleeding. > > The FDA notes that although a sustained fever of 100.4°F or > higher, severe abdominal pain, or pelvic tenderness in the > days after a medical abortion may be particularly indicative > of infection, some infections may present atypically, with no > fever, bacteremia, or significant findings on pelvic examination. > > Providers of medical abortion and emergency department care > are advised to investigate the possibility of sepsis in > afebrile patients presenting with symptoms of general malaise > (nausea, vomiting, or diarrhea and weakness), with or without > abdominal pain, more than 24 hours after taking misoprostol. > A complete blood count may be needed to identify patients > with hidden infection. > > Immediate treatment with an antibiotic regimen effective > against anaerobes bacteria such as C sordellii should be > considered in patients suspected of infection. > > The FDA does not recommend prophylactic therapy at this time > because of the low risk for sepsis (approximately 1 in > 100,000) and the risks inherent to antibiotic therapy, such > as severe or fatal allergic reactions and the development of > antimicrobial resistance. Furthermore, an appropriate > antibiotic regimen for this purpose has not yet been determined. > > Mifepristone is indicated for the termination of intrauterine > pregnancies that have progressed for 49 days or fewer, as > determined by the first day of the last menstrual period. It > is not indicated for use in terminating ectopic pregnancy. > > Unless a complete abortion is confirmed, 400 µg of > misoprostol should be administered on day 3 after oral > administration of 600 mg of mifepristone. Surgical > termination is recommended if complete termination has not > been confirmed after 2 weeks. The FDA notes that the safety > and effectiveness of intravaginally administered oral tablets > has not been established. > > > regards > > Meena Samtani > > > --------------------------------- > Love cheap thrills? Enjoy PC-to-Phone calls to 30+ countries > for just 2¢/min with Yahoo! Messenger with Voice. > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 11, 2006 Report Share Posted April 11, 2006 Is Mifepristone really abortion drug ..... The MRs always come with many studies saying it is a wonder drug but as i approve of misoprostol i strongly disagree about mifepristone. I have seen more faliure with mifeprostone in first trimester, second trimester,and induction of labour. As far as first trimester abortion or medical abortion only one patient had complete abortion but in others I had to resort to surgical intervention. Regards to second trimester abortion misoprostol is far superior to the drug.Lastly for induction of labour the drug is superior only to placebo (Cochrane2005) regards Prasad Lele 88' Lt Col P R Lele MS, DNB. Graded Specialist (Obs & Gyn) 167 Military Hospital C/o 56 APO > >Reply-To: mgims >To: <mgims > >Subject: RE: abortion drug >Date: Mon, 10 Apr 2006 19:38:19 +0100 > >Difficult to blame infection on Mifepristone. It would more be related to >the abortion process. Like many drugs we use ---- not all are >approved/licensed for use. We still use them...... > >With regards > >L/M Prasad >(lp1960@...) > > >Wish a very happy and cheerful day keep smiling > > > > > abortion drug > > > > > > > > Medscape Alert > > Abortion Drug Mifeprex Linked to 2 More Deaths > > > > Yael Waknine > > --> > > March 17, 2006 — The US Food and Drug Administration (FDA) > > has notified healthcare professionals of 2 additional deaths > > after medical abortion with mifepristone (Mifeprex 200-mg > > tablets, made by Danco Laboratories, LLC), according to an > > alert sent today from MedWatch, the FDA's safety information > > and adverse event reporting program. > > > > After verbal notification of the deaths by the manufacturer, > > an FDA investigation was launched into their circumstances. > > Although use of mifepristone was previously linked to 4 > > deaths from Clostridium sordellii-associated sepsis, the > > causes of death for the present cases remain unconfirmed. > > > > Abortion providers and patients are reminded to consider the > > specific circumstances and directions for use of mifepristone > > prior to initiating therapy. Potential adverse events such as > > sepsis should also be discussed, and patients warned of early > > signs and symptoms that may require immediate medical > > evaluation, such as fever, abdominal pain, and heavy bleeding. > > > > The FDA notes that although a sustained fever of 100.4°F or > > higher, severe abdominal pain, or pelvic tenderness in the > > days after a medical abortion may be particularly indicative > > of infection, some infections may present atypically, with no > > fever, bacteremia, or significant findings on pelvic examination. > > > > Providers of medical abortion and emergency department care > > are advised to investigate the possibility of sepsis in > > afebrile patients presenting with symptoms of general malaise > > (nausea, vomiting, or diarrhea and weakness), with or without > > abdominal pain, more than 24 hours after taking misoprostol. > > A complete blood count may be needed to identify patients > > with hidden infection. > > > > Immediate treatment with an antibiotic regimen effective > > against anaerobes bacteria such as C sordellii should be > > considered in patients suspected of infection. > > > > The FDA does not recommend prophylactic therapy at this time > > because of the low risk for sepsis (approximately 1 in > > 100,000) and the risks inherent to antibiotic therapy, such > > as severe or fatal allergic reactions and the development of > > antimicrobial resistance. Furthermore, an appropriate > > antibiotic regimen for this purpose has not yet been determined. > > > > Mifepristone is indicated for the termination of intrauterine > > pregnancies that have progressed for 49 days or fewer, as > > determined by the first day of the last menstrual period. It > > is not indicated for use in terminating ectopic pregnancy. > > > > Unless a complete abortion is confirmed, 400 µg of > > misoprostol should be administered on day 3 after oral > > administration of 600 mg of mifepristone. Surgical > > termination is recommended if complete termination has not > > been confirmed after 2 weeks. The FDA notes that the safety > > and effectiveness of intravaginally administered oral tablets > > has not been established. > > > > > > regards > > > > Meena Samtani > > > > > > --------------------------------- > > Love cheap thrills? Enjoy PC-to-Phone calls to 30+ countries > > for just 2¢/min with Yahoo! Messenger with Voice. > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 30, 2006 Report Share Posted April 30, 2006 Thanks to Malini, Meena, Kishore and Prasad for their views on Misoprostol. ( It seems Anchita did not want to speak on this issue !!? ) As regards my questions related to legality, it seems there is no legal stand on this by Indian FDA. I personally agree with the views of Kishore and I use the drug routinely. My schedule is little different. I give one tablet of Mifeprostone orally followed by two (400mcg) of Misoprostol in two hours vaginally and call them in 24 hrs for confiramation by USG. Almost 80% abort completely.This I do within 49 days of LMP. For failures, as per patient's choice, either I go for Suction Curretage or repeat dose of Misoprostol(400mcg) again.and wait for another day. For second triamaster MTPs Misoprostol 200mcg vaginally stat then after two hrs then after every 4hrs till pains reach 2-3 contraction every 10 minutes. I repeat teh dose only if the pains diminish. Usually I require hardly 3 to 4 tablets for teh same. For induction 25 mcg of Misoprostol Vaginally is more than enough. For prevention of PPH one tablet rectally is enough. Tahnks again !! Mukund (1974) Quote Link to comment Share on other sites More sharing options...
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