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    Pregnancy and Breastfeeding Risk Categories: Medications O

    Tamiflu

    From Ofloxacin to Oxytocin, learn about the safety of the most common medications during pregnancy and breastfeeding with the following general overview of drugs that begin with the letter O.

    MedicationPregnancy Risk CategoryBreastfeeding Risk Category
    Octreotide Acetate
    (SandoSTATIN, SandoSTATIN LAR, Octreotide Acetate Injection, Octreotide Acetate Omega)
    BL3
    Octreotide Acetate + 111Indium Octreotide
    (Sandostatin LAR, OctreoScan, 111Indium Octreotide, Octreotide Acetate)
    BL3 (nonradioactive octreotide)
    L4 (radioactive octreotide)
    Ofatumumab
    (Arzerra)
    CL3
    Ofloxacin
    (Floxin, Ocuflox, Tarivid)
    CL2
    Olanzapine
    (Zyprexa, Symbyax, Relprevv)
    CL2
    Olmesartan Medoxomil
    (Benicar, Benicar HCT)
    C (first trimester)
    D (second, third trimesters)
    L3
    Olopatadine Ophthalmic
    (Patanol, Opatanol, Patanase, Pataday)
    CL2
    Olsalazine
    (Dipentum)
    CL3
    Omalizumab
    (Xolair)
    BL3
    Omega-3-Acid Ethyl Esters
    (Lovaza, Fish Oil)
    CL3
    Omeprazole
    (Prilosec, Losec)
    CL2
    Ondansetron
    (Zofran, Zuplenz)
    BL2
    Oral Contraceptives
    (Norinyl, Norlestrin, Ovral, Ortho-Novum, Nornyl, Cilest, Brevinor)
    XL3
    Orlistat
    (Xenical, Alli)
    BL3
    Orphenadrine Citrate
    (Norflex, Banflex, Norgesic, Flexon, Disipal, Orfenace, Norgesic)
    CL3
    Oseltamivir Phosphate
    (Tamiflu)
    CL2
    Osmotic Laxatives
    (Milk of Magnesia, Fleet Phospho-Soda, Citrate of Magnesia, Epsom Salt, Acilac, Citromag, Sorbilax, Duphalac)
    CL1
    Oxaliplatin
    (Eloxatin, Eloxatine, O-Plat, Oxalip)
    DL5
    Oxaprozin
    (Daypro)
    CL3
    Oxazepam
    (Serax, Apo-Oxazepam, Novoxapam, Zapex, Alepam, Murelax, Serepax, Oxanid)
    DL3
    Oxcarbazepine
    (Trileptal)
    CL3
    Oxybutynin
    (Ditropan, Apo-Oxybutynin, Oxybutyn)
    BL3
    Oxycodone
    (Tylox, Percodan, OxyContin, Roxicet, Endocet, Roxiprin, Percocet, Supeudol, Endone, Proladone)
    BL3
    Oxymetazoline
    (Afrin, Nasacon, Sinarest Nasal, Duramist Plus, Visine L.R., Vicks Sinex 12 Hour, Neo-Synephrine 12 Hour, 4-Way Long Lasting)
    CL3
    Oxymorphone
    (Numorphane, Opana)
    CL3
    Oxytocin
    (Pitocin, Toesen, Syntocinon, Syntometrine)
    XL2

     

    Pregnancy Risk Categories

    A. Controlled Studies Show No Risk

    Adequate, well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester of pregnancy.

    B. No Evidence of Risk in Humans

    Adequate, well-controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility.

    C. Risk Cannot Be Ruled Out

    Adequate,well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is administered during pregnancy, but the potential benefits may outweigh the potential risks.

    D. Positive Evidence of Risk

    Studies in humans, or investigational or post-marketing data, have demonstrated fetal risk. Nevertheless, potential benefits from the use of the drug may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

    X. Contraindicated in Pregnancy

    Studies in animals or humans, or investigational or post-marketing reports, have demonstrated positive evidence of fetal abnormalities or risks which clearly outweighs any possible benefit to the patient.

    Breastfeeding Risk Categories

    L1. Safest

    Drug which has been taken by a large number of breastfeeding mothers without any observed increase in adverse effects in the infant. Controlled studies in breastfeeding women fail to demonstrate a risk to the infant and the possibility of harm to the breastfeeding infant is remote, or the product is not orally bioavailable in an infant.

    L2. Safer

    Drug which has been studied in a limited number of breastfeeding women without an increase in adverse effects in the infant; and/or, the evidence of a demonstrated risk which is likely to follow use of this medication in a breastfeeding woman is remote.

    L3. Moderately Safe

    There are no controlled studies in breastfeeding women; however, the risk of untoward effects to a breastfed infant is possible; or, controlled studies show only minimal non-threatening adverse effects. Drugs should be given only if the potential benefit justifies the potential risk to the infant.

    L4. Possibly Hazardous

    There is positive evidence of risk to a breastfed infant or to breastmilk production, but the benefits of use in breastfeeding mothers may be acceptable despite the risk to the infant (e.g. if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

    L5. Contraindicated

    Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant. The risk of using the drug in breastfeeding women clearly outweighs any possible benefit from breastfeeding. The drug is contraindicated in women who are breastfeeding an infant.

    Disclaimer: The information provided in this article is not meant to replace the professional medical advice from your health care provider. For detailed information on specific medications or for information on medications not listed, please consult your health care provider.

    References

    Hale, Thomas W. 2008. Medications and mothers’ milk, 13th edn. Amarillo, Texas: Hale Publishing.
    Hale, Thomas W. 2010. Medications and mothers’ milk, 14th edn. Amarillo, Texas: Hale Publishing.
    Hale, Thomas W. 2012. Medications and mothers’ milk, 15th edn. Amarillo, Texas: Hale Publishing.
    Safe Fetus: http://safefetus.com/index.php
    Search Medica RX: http://www.mims.com/USA

    Image Credits

    Tamiflu: http://commons.wikimedia.org/wiki/File:Tamiflu_pill_Roche.jpg

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