Alprazolam in Pregnancy and Breastfeeding
Risk Factor: DM
Class: Central nervous system drugs
/ Sedatives and hypnotics
Fetal Risk Summary
Alprazolam, a member of the benzodiazepine class of agents, is used for the treatment of anxiety. Although no congenital anomalies have been attributed to the use of alprazolam during human pregnancies, other benzodiazepines (e.g., see Diazepam) have been suspected of producing fetal malformations after 1st trimester exposure. In pregnant rats, the drug produced thoracic vertebral anomalies and increased fetal death only at the highest dose (50 mg/kg) tested (1).
Researchers described the effects of alprazolam exposure on gestational day 18 (i.e., near term) on the neurodevelopment of mice in a series of reports (2,3 and 4). In one strain of mice, exposure induced persistent imbalance in the newborn and hind limb impairment in the adult offspring suggesting a defect in cerebellar development (2). In the second part of this study, in utero exposure to the drug (0.32 mg/kg orally) did not increase anxiety in adult offspring but did reduce motivation (3). A decrease in the tendency to engage in group activity and an increase in male aggression was observed in the third part of the study (4).
No data have been located on the placental passage of alprazolam. However, other benzodiazepines, such as diazepam, freely cross the placenta and accumulate in the fetus (see Diazepam). A similar distribution pattern should be expected for alprazolam.
One manufacturer has received 441 reports of in utero exposure to alprazolam or triazolam, two short-acting benzodiazepines, almost all of which occurred in the 1st trimester (5,6). Although most of the women discontinued the drugs when pregnancy was diagnosed, 24 continued to use alprazolam throughout their gestations (5). At the time of publication, about one-fifth of the 441 cases were still pregnant; one sixth had been lost to follow-up and one sixth had been terminated by elective abortion for various reasons (5). Spontaneous abortion or miscarriage (no congenital anomalies were observed in the abortuses) occurred in 16 women; two pregnancies ended in stillbirths; and one newborn infant died within 24 hours of birth. Most of the remainder of the reported exposures ended with the delivery of a normal infant. The manufacturer also received two retrospective reports of congenital defects after alprazolam exposure (5). One of the cases involved an infant with Down's syndrome after maternal consumption of a single 5.5-mg dose of alprazolam and an unknown amount of doxepin during pregnancy (5). The second report involved a mother who ingested 0.5 mg/day of alprazolam during the first 2 months of gestation and was delivered of an infant with cat's eye with Pierre Robin syndrome. Neither of these outcomes can be attributed to alprazolam.
A 1992 Reference reported the prospective evaluation of 542 pregnancies involving 1st trimester exposure to alprazolam gathered by a manufacturer from worldwide surveillance (7). These data were an extension of the data provided immediately above. Of the total, 131 (24.2%) were lost to follow-up. The outcome of the remaining 411 pregnancies was 42 (10.2%) spontaneous abortions, 5 (1.2%) stillbirths, 88 (21.4%) induced abortions, and 263 (64.0%) infants without and 13 (3.2%) infants with congenital anomalies. A total of 276 live births occurred, but two of these infants, both born prematurely, died shortly after birth. One, included in the group with congenital anomalies, had bilateral hydroceles and ascites, whereas the other died after intraventricular hemorrhage. The type and incidence of defects were comparable to those observed in the Collaborative Perinatal Project with no pattern of defects or excess of defects or spontaneous abortions apparent (7).
A second 1992 study reported on heavy benzodiazepine exposure during pregnancy from Michigan Medicaid data collected during 1980 to 1983 (8). Of the 2,048 women, from a total sample of 104,339 who had received benzodiazepines, 80 had received 10 or more prescriptions for these agents. The records of these 80 women indicated frequent alcohol and substance abuse. Their pregnancy outcomes were three intrauterine deaths, two neonatal deaths in infants with congenital malformations, and 64 survivors. The outcome for 11 infants was unknown. Six of the surviving infants had diagnoses consistent with congenital defects. The investigators concluded that the high rate of congenital anomalies was suggestive of multiple alcohol and substance abuse, and may not have been related to benzodiazepine exposure (8).
Single case reports of pyloric stenosis, moderate tongue-tie, umbilical hernia and ankle inversion, and clubfoot have been received by the manufacturer after in utero exposure to either alprazolam or triazolam (5). In addition, the manufacturer has received five reports of paternal use of alprazolam with pregnancy outcomes of two normal births, one elective abortion, one unknown outcome, and one stillbirth with multiple malformations (5). There is no evidence that the drug affected any of these outcomes.
Neonatal withdrawal after in utero exposure to alprazolam throughout gestation has been reported in three infants (5, 9). In two cases involving maternal ingestion of 3 mg/day and 78 mg/day, mild withdrawal symptoms occurred at 2 days of age in the infant exposed to 3 mg/day (5). No details were provided on the onset or severity of the symptoms in the infant exposed to the higher dose. The third neonate was exposed to 1.01.5 mg/day (9). The mother continued this dosage in the postpartum interval while breast feeding. Restlessness and irritability were noted in the infant during the 1st week. The symptoms worsened 23 days after the breast feeding was stopped on the 7th day because of concerns over drug excretion into the milk. Short, episodic screams and bursts of crying were observed frequently. Treatment with phenobarbital was partially successful, allowing the infant to sleep for longer periods. However, on awakening, jerking movements of the extremities and crying continued to occur. The infant was lost to follow-up at approximately 3 weeks of age.
Breast Feeding Summary
Alprazolam is excreted into human breast milk (9). Eight lactating women, who stopped breast feeding their infants during the study, received a single 0.5-mg oral dose and multiple milk and serum samples were collected up to 36 hours after the dose. Transfer into milk was consistent with passive diffusion. The mean milk:serum concentrations ratio (using area under the drug concentration-time curve) was 0.36, indicating that a nursing infant would have received 0.35 g/kg/day, or about 3% (body weight adjusted) of the maternal dose (9).
A brief 1989 report, citing information obtained from the manufacturer, described a breast-fed infant whose mother took alprazolam (dose not specified) for 9 months after delivery but not during pregnancy (10). The mother tapered herself off of the drug over a 3-week period. The nursing infant exhibited withdrawal symptoms consisting of irritability, crying, and sleep disturbances that resolved without treatment after 2 weeks.
Because of the potent effects the drug may have on a nursing infant's neurodevelopment, the case of probable alprazolam withdrawal, and the lethargy and loss of body weight observed with the chronic use of other benzodiazepines (see Diazepam), alprazolam should be avoided during lactation.
References
- Esaki K, Oshio K, Yanagita J. Effects of oral administration of alprazolam (TUS-1) on the rat fetus: experiment on drug administration during the organogenesis period. Preclin Rep Cent Inst Exp Anim 1981;7:6577. As cited in Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD:Johns Hopkins University Press, 1989:32.
- Gonzalez C, Smith R, Christensen HD, Rayburn WF. Prenatal alprazolam induces subtle impairment in hind limb balance and dexterity in C57BL/6 mice (abstract). Teratology 1994;49:390.
- Christensen HD, Pearce K, Gonzalez C, Rayburn WF. Does prenatal alprazolam exposure increase anxiety in adult mice offspring (abstract)? Teratology 1994;49:390.
- Rayburn W, Gonzalez C, Christensen D. Social interactions of C57BL/6 mice offspring exposed prenatally to alprazolam (Xanax) (abstract). Am J Obstet Gynecol 1995;172:389.
- Barry WS, St Clair SM. Exposure to benzodiazepines in utero. Lancet 1987;1:14367.
- Ayd FJ Jr, ed. Exposure to benzodiazepines in utero. Int Drug Ther Newslett 1987;22:378.
- St. Clair SM, Schirmer RG. First-trimester exposure to alprazolam. Obstet Gynecol 1992;80:8436.
- Bergman U, Rosa FW, Baum C, Wiholm B-E, Faich GA. Effects of exposure to benzodiazepine during fetal life. Lancet 1992;340:6946.
- Oo CY, Kuhn RJ, Desai N, Wright CE, McNamara PJ. Pharmacokinetics in lactating women: prediction of alprazolam transfer into milk. Br J Clin Pharmacol 1995;40:2316.
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Anderson PO, McGuire GG. Neonatal alprazolam withdrawalpossible effects of breast feeding. DICP Ann Pharmacother 1989;23:614.
Questions and Answers
Alprazolam?, Does anyone no how much it cost for 30 tablets/0.5mgs of Alprazolam for anxiety and yes I have a percriptions for it.
HI:
The amount of a month supply of medication varries month to month depending on the pharmacy and also the med company.
I will assume that you do not have insurance if you are searching for the cost of a particular med at no specific pharmacy.
First I would say that baseline may be somewhere between $20.00 - $30.00 and I think this is on the high side. Call your local pharmacies and they can give you a more direct answer. They will also be able to help you if you do have insurance so ins. co's offer mail order at a reduced co-pay etc. If you do not have insurance then WHY NOT? You are entitled to medical coverage in some way for or another.
Please if you are uninsured medically, please check w/ your pharmacist (if they are willing to help), if not then use your recousces like friends, family, net, people here on answers and see if there are any ideas for some coverage for you. It's important.
I hope this helped.
Take Care.
How long does the drug alprazolam take to work in your system?, My husband is taking alprazolam for a strained muscle. But it is not helping him. He just started taking it thursday. We just wanted to know how long it took before we start seeing results.
Alprazolam is for nervousness and anxiety. I have never heard of it being used for a strained muscle.
How long does Alprazolam to work in your system?, How long does Alprazolam take to work in your system? I am going for a haircut tommorrow where some of my panic attacks occurred. My haircut tommorrow is 930am. How long beore my haircut should I take the pill? Should I tell the person that cuts my hair about the condition? Has anybody ever had a panic attack at a barber shop?
Xanax works relatively fast, within 30-45mins. If your appt. is @ 9:30 am. It would be best to take it during that time frame. Do NOT tell your hairdresser or anyone else for that matter. It is your own personnel business, unless, you feel that it is necessary to tell someone. I have never had a panic attack at the hairdresser's but, I have had them just grocery shopping. We all (those who suffer from panic attacks/anxiety) have our own " triggers" that cause such feelings. I hope that this has helped.
What is the difference between Xanax and Alprazolam?, Is Alprazolam the generic version of Xanax? What is the difference in effectiveness and cost of the generic version of Xanax? Please add reliable sources to your answer thank you?
Xanax is a trade name for the generic drug alprazolam. There should be absolutely no difference in the drug and its effectiveness between generic and trade name versions. Generally the generic versions are cheaper. There is a period of time after a drug is developed where it is not allowed to be copied and during this period the drug company are able to recover the cost of developing the drug by having no competition and setting the price they feel is appropriate. Allowing production of generics allows competition in the market and brings the cost of drugs down.
In the UK the NHS prefers doctors to prescribe generic drugs as they are cheaper. However Xanax is not an expensive drug (about 15p per tablet) and so there is likely to be only a small saving on the generic drug.
What is the difference between the green Alprazolam and the white Alprazolam?, Are they the same strength? Or is the green one just a generic one that is not as strong as the white or yellow Alprazolam? Are the green ones even Alprazolam?
I haven't seen a "green" one, but maybe you're referring to the bluish color (or at least that's the way I see it). Alprazolam is the generic brand, and Xanax is the "brand" name. The white kind is only .25 mg, the peach is .5 mg, and the blue is 1 mg.
Here is a website that tells more and shows pictures:
http://www.psychtreatment.com/pictures_o...
Hope this helps!
If I were to take a Alprazolam before bed would it help avoid a panic attack in the morning?, I am beginning to understand my panic attck pattern a little better and I am thinking that I am going to wake up very anxious. Wouls it help to take a Alprazolam before bed to avoid an ealry morning attack.
It might. It won't hurt to try. Just don't take more than you should because they can be very addicting and you really don't want that. You also might want to seriously consider doing yoga at night before you sleep. I used to have panic attacks about 5 years ago and one day it just stopped. I don't know if it's because I got a little older or what but one thing that really helped me was this book called The Self Esteem Companian. You can search it on Amazon. I was looking for self help books and found this book at the book store. It really doesn't have anything to do specifically with panic attacks but it really helped me. There are exercises (mental and visual) in there that they have that are really awesome. You should check it out. Maybe you could take the Alprazolam right when you wake up. Seriously though, that book might really help you,.
Insomnia how long to taper off Alprazolam to healthier alternative. I am tired of side effects.?, I have had trouble for years sleeping and use sleep prescription. I want to taper off and find natural remedies. Could you please answer these two quesions?
How long does it take to taper off 1 mg nightly of Alprazolam without withdrawals?
I started taking Vitamin D, Omega 3 and magnesium as a beggining to taper off Alprazolam.any other healthier not so addictive alternatives you can tell me.
Thanks!
Not really sure how to taper off. Ask your MD
But may I suggest Valerian to help you sleep. It's a herb and I got it at Whole Foods.
What is the diffrence between XANAX XR and ALPRAZOLAM ER?, Does anyone know what the difference is between the two XANAX XR and ALPRAZOLAM ER? I went to my doctor today and ask him to put me on Xanax XR when I filled my prescription i looked at the bottle and it reads Alprazolam ER.Did I get the wrong medication? I can't call my doctor or pharmacy until the morning.Does anyone know if they are the same thing? Any info would be greatly appreciated.Thanks in advance and God Bless.
Xanax XR is the original brand name. Most pharmacies substitute generics when available unless you or your doctor specifically tells them not to. Alprazolam ER is the generic name for Xanax XR, so it simply means they gave you the generic. You save considerable amounts of money by getting generic drugs because companies that make these do not have to include the cost of research and marketing in the price of the drug. In the U.S., drugs can go generic 20 years after they are originally patented. They are safe and FDA approved.
(By the way, both XR and ER mean "extended-release." Companies use many different abbreviations for "extended-release," including CR and XL.)
What happens if you mix hydrocodone a pian killer and alprazolam (like xanix)?, My Friend is talking about mixing hydrocodone and alprazolam. I keep telling her that mixing drugs is not the best choice. I am concerned what will happen to her when she gets them.
Nothing, I pass meds at a nursing home and many of our residents receive Xanax (Alprazolam) and Lortab together, although if she is doing it recreationally she is evidently not the sharpest tool in the shed, it will just lead to heavier use of drugs because both of those drugs you build a tolerance too, meaning you need more and more to get the high feeling.
What is the difference between Clonazepam and Alprazolam?, What is the difference between Clonazepam and Alprazolam (xanax)?
Clonazepam (Klonopin) has a longer half-life in your system, and generally takes around an hour to become effective and stays active about 12 hours in your system. Xanax kicks in a lot sooner and stays active about 4-5 hours. Both are highly addictive, so watch yourself!
