The FDA is adding a boxed warning to the injectable bronchodilator medication terbutaline to caution against using the drug off-label for prevention or prolonged treatment (longer than 48 to 72 hours) of preterm labor in pregnant women. The FDA is also warning against using the oral form of the drug for these purposes because it is not proven to be effective and has a similar risk profile.
The agency has received postmarketing reports of serious adverse reactions in women who were given the drug for obstetric uses. The reactions include increased heart rate, cardiac arrhythmias, pulmonary edema, myocardial ischemia, hypokalemia, hyperglycemia, and death.
The FDA concludes that "the risk of serious adverse events outweighs any potential benefit to pregnant women."
LINK(S):
FDA MedWatch alert (Free)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243843.htm
The agency has received postmarketing reports of serious adverse reactions in women who were given the drug for obstetric uses. The reactions include increased heart rate, cardiac arrhythmias, pulmonary edema, myocardial ischemia, hypokalemia, hyperglycemia, and death.
The FDA concludes that "the risk of serious adverse events outweighs any potential benefit to pregnant women."
LINK(S):
FDA MedWatch alert (Free)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243843.htm
Published in Physician's First Watch February 18, 2011
اللَّهُمَّ نَجِّ الْمُسْتَضْعَفِينَ مِنَ الْمُؤْمِنِينَ اللَّهُمَّ اشْدُدْ وَطْأَتَكَ عَلَى مُضَرَ اللَّهُمَّ اجْعَلْهَا عَلَيْهِمْ سِنِينَ كَسِنِي يُوسُفَ
Tue, 2011-02-22 18:51

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