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The FDA has now made two revisions to its premarket approval and marketing plan. The first, "to increase patient awareness," says the FDA, will provide updates on the "potential risks associated with using the drug in first trimester of pregnancy." The second, "on patient safety issues," suggests that patients can ask doctors to prescribe medication early at the first sign of depression at any phase pregnancy, or after the first trimester.
The FDA is also issuing a press release emphasizing that while there was no clinical evidence that pregabalin would have an effect on fetal development, "the FDA is providing this information to health care providers and pregnant women with concerns that pregabalin may pose to pregnancy or the health of fetus" (emphasis added).
The agency also published an online "Know Your Rights" pamphlet on the "pregnancy benefits of antidepressants such as the selective serotonin reuptake inhibitor (SSRI)" which, like the media release, makes no specific reference to "fetus." That pamphlet is available on the FDA website.
What this means is that in any case where women who were taking the drug before it started to have negative effects on them ask for a doctor to prescribe later-starting version of the drug, that is a potentially good reason to try avoid starting treatment at, or before, this point in pregnancy. On the other hand, given that drug is supposed to be safer than other antidepressants, it's a potentially good reason to try have a baby before then.
While it's certainly possible that there are cases in which someone will be able to get the benefits of therapy without ever using a pregabalin before the last 10 weeks of pregnancy, the FDA press release is clear about the reasons they think this is hard to do. The FDA says that "the risk of developing depression or suicidal thoughts is greater for patients who started treatment before the first full trimester.
"Therefore," it continues, "the FDA strongly recommended that patients with depression who were taking these drugs use them only after the first trimester of pregnancy, when depression is most likely to recur, maximize their benefits."
The reason for this is that antidepressants like are not completely selective serotonin reuptake inhibitors — they also reduce (but temporarily alleviate) the effects of serotonin neurotransmitters like norepinephrine. These effects are more pronounced in the early and more vulnerable preborn of mothers with bipolar disorder — for whom these antidepressants where can i buy emulsion gel nifedipine are often taken.
The FDA is going a step further to make it clear where the potential dangers of untreated depression might lie. When it makes recommendations about treatment for pregnant women with depression, the agency emphasizes that antidepressants decrease (but temporarily alleviate) the symptoms of depression have been shown to be associated with serious neonatal risks that are particularly dangerous to a baby's developing nervous system.
The agency says its concerns about antidepressants that increase neonatal risk.
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Two brothers accused of stabbing a Muslim woman in her car outside a mosque have appeared in court.
Mohammed Ahmed, 23, and his brother Basharat, 21, pleaded not guilty to attempted murder on Wednesday.
Basharat Ahmed, who had been arrested in January, will face a retrial on the same charge.
The brothers were arrested during an incident outside The Al-Mazrourah Mosque in Bolton following anti-Islam comments made by a woman in the group.
Mohamed Ahmed was charged with attempted murder after she was slashed in the stomach as she sat outside in her car on September 19, 2017.
(Image: Facebook)
He and Basharat Ahmed have been remanded in custody and a preliminary hearing is due on.
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