10.09.2014

Pregnancy medicine category list

Paternal therapy with disease modifying drugs in multiple sclerosis and pregnancy outcomes: a prospective observational multicentric study. Final results from the Betaseron (interferon ?-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events. The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis. Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis.
Research presented at the NIH conference confirmed that in some rare instances, Sapropterin had been prescribed to pregnant PKU patients, but only when the woman could not achieve dietary control at the start of her pregnancy. In addition to these two case studies, the NIH panel reported that other pregnancies involving the use of Sapropterin were currently underway. Even though the maker of Kuvan, BioMarin, does in fact encourage pregnant women who were exposed to Kuvan during their pregnancy to participate in ongoing studies about the drug’s effect, there are no plans for future controlled studies. In the public-health setting, a variety of mental-health conditions ranging from depression to bipolar disorder (BD) are encountered, but these illnesses are not always treated appropriately during pregnancy. In the evaluation of drug therapy during pregnancy, teratogenicity and embryotoxicity must be considered. To make an accurate recommendation to other health care providers (HCPs) regarding which psychotropics are safe during pregnancy, it is important to consider the FDA's pregnancy safety ratings (categories A, B, C, D, and X). Pregnancy categories A and B are considered the safest, but none of the antidepressant medications has a category A or B rating. Antidepressants that have not been categorized include bupropion, mirtazapine, trazodone, and nefazodone. If a patient currently receiving antidepressant therapy wishes to become pregnant, it is important to consider her mental health and medical history as well as her current medications. Ziprasidone: Currently, no case reports exist of ziprasidone administered during pregnancy.
The risks associated with typical antipsychotics are minimal, and these drugs can be used safely during pregnancy. The treatment of BD during pregnancy is generally deemed appropriate, as the risk to the infant from uncontrolled BD is greater than the potential drug effects in utero.
This seems like an awesome feature for when you find yourself in a doctor’s office and have to list all the current medications you are taking. I managed to log-on during my lunch break and listened intently to a session on PKU and Pregnancy. That is because when ranked on the FDA’s pregnancy classification of drugs, Sapropterin is considered a category C drug since it is still unclear whether Sapropterin crosses the human placenta.
In addition to concerns about whether Sapropterin harms a developing fetus, doctors admitted it was hard to determine if symptoms such as headache, rhinorrhea, vomiting, fever, abdominal pain, rashes or nasal congestion were a result of the prescription drug or simply associated with the pregnancy. Based on what little has been conducted, including the two case studies I’ve mentioned here, initial reports of using Sapropterin during pregnancy are encouraging. Damage caused by teratogens occurs during the first trimester of pregnancy, and malformations of fetal organs or skeletal structures may be seen.1 Embryotoxicity can occur when drugs are given in the second or third trimester. To categorize symptoms, a retrospective study of fetal exposure to antidepressants in the last 3 weeks of pregnancy was conducted in 73 neonates born in secondary and tertiary care hospitals.4 Not all infants had been exposed to antidepressants.


However, data and case studies concerning these drugs' effects on neonates when used during pregnancy are limited. Extensive studies of neonatal outcomes and adverse events when these agents are taken throughout pregnancy have not been conducted.
While most of the data on the teratogenic effects of phenothiazines come from testing in mice and rats, one study examined outcomes of pregnancies in which the mother received phenothiazine.7 Exposure to phenothiazines was found to be brief since these agents are used to treat hyperemesis gravidarum (severe morning sickness), not psychotic disorders. Cases of major congenital anomalies and neonatal adverse reactions have been reported, but several other reports describe healthy outcomes in infants who were exposed to olanzapine during all stages of pregnancy.7 Olanzapine also has been implicated in major metabolic complications of pregnancy, such as gestational diabetes. Pregnancy is not a risk to women with MS, and the rate of relapse during pregnancy actually tends to decrease.
To my surprise, much of the PKU and Pregnancy presentation focused on Sapropterin and its use during maternal PKU (Sapropterin is the generic name for Kuvan, the first prescription drug approved by the U.S. Richard Koch, FDA, Kuvan, Kuvan responder trial, maternal PKU, National Institutes of Health, NIH, Phenylalanine, Phenylketonuria, PKU, PKU and Pregnancy, PKU research, Sapropterin, sapropterin dihydrochloride, U.S.
This article reviews the various psychotropic medications and how they should or should not be used during pregnancy.
Data from the Slone Epidemiology Center Birth Defects Study and the National Birth Defects Prevention Study indicated a possible increase in risk of congenital cardiac malformations with first-trimester exposure to paroxetine.1 This prompted the manufacturer to change the pregnancy category from C to D.
Neonates were grouped into three categories based on literature describing serotonergic toxicity, antidepressant discontinuation syndrome, and neonatal immaturity. A new look at the neonate's clinical presentation after in utero exposure to antidepressants in late pregnancy. The safety of medications for the treatment of bipolar disorder during pregnancy and the puerperium.
The patient was responsive to Sapropterin and during her pregnancy, she continued the medication at 40, 60, and 100 mg per day in the first, second, and third trimesters.
Pregnancy is often an exclusion criterion in clinical trials of antidepressants; therefore, limited data exist regarding adverse events of these medications in pregnancy.
Based on current literature, avoidance of paroxetine is recommended in all trimesters.6 Because of limited data on duloxetine, this drug should not be taken during pregnancy. Pregnancy registries created by manufacturers and practitioners' case reports provide information about adverse reactions that have occurred since the medications entered the market. The respective pregnancy categories and dosages of the various antidepressants appear in TABLE 1. TABLE 2 lists the respective pregnancy categories and dosages of the various antipsychotic medications. Gabriella Pridjian from Tulane Hayward Genetics Center, reported on another pregnant PKU patient who had difficulty tolerating low-phe protein supplements.
I'm not going to keep trying [to conceive] forever, because I want to get back on my meds.” Indeed, the advice is for patients to stop taking all currently available DMTs for 1 or more months before becoming pregnant. In an interview with MSDF she said, “Something that's really important to keep in mind—and this is a good tip for community physicians—if a person is on DMT and thinking about pregnancy, if that person is taking oral contraceptives, it's really important to discontinue the use of oral contraceptive pills and use a different means of birth control, while the person is on DMT, to establish a regular cycle while the person's MS is still covered by the DMT, prior to doing a washout for pregnancy.
The drugs are given a category of A, B, C, D, or X.  Only one DMT, teriflunomide, is classified in pregnancy category X. In this case, animal or human studies have demonstrated fetal abnormalities, and the risk of use in pregnant women outweighs the benefits.


Crabtree-Hartman explained, “With all of the agents, the preference is that pregnancy or conception occurs when the patient is off of medication. Glatiramer acetate (GA) is an exception.” That is because GA (Copaxone, Teva) is classified as pregnancy category B, the safest among DMTs. All other current DMTs are category C, in which animal studies have shown adverse effects on the fetus, there are no well-controlled studies in humans, but potential benefits may warrant the use of the drugs.
In these cases, the neurologist needs to assess whether the use for the patient is worth the potential risk to the fetus. Obtaining enough data in humans is difficult, given the ethical considerations of doing testing in pregnant women. Rather, pharmaceutical companies are required to set up pregnancy registries, in which patients can report accidental pregnancies while taking DMTs. Since then, Bayer also published its pregnancy registry data (Coyle et al., 2014) for Betaseron. The study only included 66 pregnancies with exposure to fingolimod and, while some negative outcomes were reported, the results were not conclusive due to the small size of the study. This is not surprising, since there are no set guidelines in place, aside from the label indications, to guide clinicians in the selection of DMTs for any MS patient, let alone for patients who wish to become pregnant. On the idea of generating an algorithm to help select a DMT, Crabtree-Hartman remarked, “It is so difficult to do, because the variables leading into decisionmaking are not just based on our opinion or our clinical experience or even published literature from large data sets. As a pregnancy category C DMT, its use in pregnant women is not recommended, since it can cross the placenta after the first trimester.
The investigators do suggest having a pediatrician involved as part of the patient’s medical team, since the use of this DMT during the third trimester can cause hematologic alterations in the newborn baby. One group goes further than most to advocate the use of other DMTs during the first weeks of pregnancy in patients with low disease activity, although these investigators acknowledge that more studies are needed before making a definitive suggestion. They collected data from over 100 women, 61 of whom had taken GA, IFN, or corticosteroids for at least the first 8 weeks of pregnancy. They showed that mothers who received no DMT during pregnancy had significantly increased EDSS scores compared to mothers who had received either DMT during pregnancy. However, the mean EDSS score at the start of pregnancy in the group of women taking DMT during pregnancy was higher than in those who did not take DMT (p = 0.02), which might confound the results.
The authors speculated that this is due to the fact that the group of patients who did not remain on DMTs when trying to conceive or while pregnant left themselves unprotected during that time, causing progression in disability, which was reflected in the higher EDSS scores measured after delivery. It is not rare that I recommend a woman should continue her treatment throughout pregnancy.” Other DMTs to consider during pregnancyThe discussion of DMT use during pregnancy raises the question of whether dimethyl fumarate (Tecfidera, Biogen) may also be considered.
The risk of rebound disease activity is unknown, so it’s unclear whether clinicians would be compelled to use it during pregnancy as with natalizumab. Animal studies have shown different toxicity levels depending on the species used (also reviewed in Cree, 2013). The lack of data showing whether rebound activity occurs after use of dimethyl fumarate or other DMTs aside from natalizumab supports the decision not to take these DMTs during pregnancy.
Therefore, a better understanding of the effect of DMTs on fetal development would also be useful for patients with unplanned pregnancies. It’s not just women with MS that need to think about whether their use of DMTs could affect their offspring. So counseling comes up with our male patients, particularly since teriflunomide was FDA-approved.“ Not only is teriflunomide a category X DMT, but it can also stay in the body for up to 2 years. In this case in particular, but also for all other DMTs, the washout period is important to consider as part of planning for pregnancy.
A month after MSDF first spoke with her, she gave us the happy news that she is now pregnant.



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