Store Brand Acetaminophen Recall Alert
US Food and Drug Administration (FDA) is recalling 500mg strength store-brand acetaminophen caplets because of contamination with small metal fragments found in some caplets. If you have bought a store-brand or private label pain reliever acetominophen, please Read more
Lamictal and Birth Defects
The US Food and Drug Administration has issued an alert about Lamictal (lamotrigine) that suggests that babies exposed to the drug during the first trimester in pregnancy may have a higher chance of being born with a cleft lift or cleft palate. Additional research is needed to establish further evidence of this observation and this alert was issued from FDA’s preliminary data analysis for Lamictal. FDA will update its alert as further information becomes available. Lamictal is manufactured and marketed by GlaxoSmithKline and is approved for the maintenance treatment of delaying future mood episodes in patients with bipolar disorder type I. Lamictal is also approved as adjunctive (add-on) therapy for patients with seizure disorders.
Treating Depression in Pregnant Women
US Food and Drug Administration (FDA) published a Public Health Advisory on treating depression in pregnant women, because doctors and moms-to-be have to weigh the risks and benefits of antidepressants during pregnancy.
A risk of stopping antidepressants for a patient suffering from depression and taking depression medication is that the patient may experience a relapse. Earlier this year, researchers studied pregnant women who stopped taking their antidepressant medication during pregnancy and pregnant women who continued taking their antidepressant medication during pregnancy. Women who stopped their meds were 5 times more likely to suffer from depression relapse than women who continued antidepressants during pregnancy.
Another study suggested potential risks from SSRI class of antidepressants taken during pregnancy. Pregnant women who took antidepressants during pregnancy gave birth to babies that were 6 times more likely to suffer from a condition called persistent pulmonary hypertension (PPHN). This is a serious and life-threatening lung condition where the blood pressure of the babies’ lungs are very high and cannot get enough oxygen into their blood. The caveat is that this is a small study and additional studies have not yet been conducted to confirm the findings of this study. Late last year, the labeling for paroxetine (Paxil or Seroxat) was changed to reflect findings that use of this drug during the first trimester may be linked to increased risk of heart birth defects.
The FDA is advising that pregnant women on antidepressants should not stop taking their medication without first seeing their doctor, and weighing carefully the risks and benefits of continuing medication treatment during pregnancy.