Terbutaline Sulphate FDA Alerts
Terbutaline sulphate is a member of a class of drugs called, "beta-agonists" . They function in a manner opposite of the class of drugs called "beta-blockers". Terbutaline sulphate is often prescribed for asthma relief and has been used "off label" to prevent early labor in pregnant women. There have been reports of neurological deficits in the newborn infants, and the FDA has issued warnings that such use is "... not approved and may cause harm to the mother and/or the fetus."
Beta-agonist Side Effects Study Findings
Another study, conducted in 2004 by Cornell and Stanford Universities, shows that prolonged use of a beta-agonist such as Terbutaline sulphate "... increases cardiac risks, such as heart attacks, by more than two-fold, compared with the use of a placebo.
"
Taken from the drug label:
"Central nervous system effects:
Fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, and psychotic states. Appetite may be reduced.
Nausea and vomiting may occur.
Cardiovascular effects:
These are complex and usually include vasoconstriction with resultant hypertension or gangrene.
Cerebral haemorrhage and pulmonary oedema.
Stimulation of beta1-adrenergic receptors of the heart may produce tachycardia, cardiac arrhythmias, anginal pain, palpitations, cardiac arrest.
Stimulation of beta2-adrenergic receptors may produce hypotension with dizziness and fainting, and flushing. Hypokalaemia may occur"
More Informaiton and Studies
Terbutaline falls into Category B of the FDA Use in Pregnancy Rating system. Animal studies have revealed no evidence of harm to the fetus; however, there are no adequate or well controlled studies in pregnant women. It is possible that animal studies have shown an adverse effect, but adequate and well controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. [
PERINATOLOGY]
Terbutaline crosses the placenta where it can stimulate receptors in fetal tissues, which in turn use betaAR input for trophic control of cell replication and differentiation. Significant statistical association between terbutaline and cardiac anomalies in epidemiological studies suggest that terbutaline may sensitize the developing heart to other insults that affect development.
[
NATIONAL LIBRARY OF MEDICINE
]
Neonatal rats are at a stage of neurodevelopment corresponding to human fetal development. This study on postnatal effects of terbutaline indicated structural abnormalities in the cerebellum, hippocampus, and somatosensory cortex. In the cerebellum, terbutaline treatment reduced the number of Purkinje cells and elicited thinning of the granular and molecular layers. [
NCBI PUB MED]
Possible Terbutaline Sulphate Side Effects Lawsuit
If you or a family member have taken Terbutaline Sulphateand have experienced any side effects, you may be entitled to compensation.
Register Your Terbutaline Sulphate Complaint
If you feel you qualify for damages or remedies that might be awarded in this possible lawsuit, please click the link below to submit your complaint.
