FDA Pregnancy Categories
Women who are pregnant or considering pregnancy are rightly concerned about whether the medicines they take might cause birth defects or other harm to their developing baby. Doctors are looking for the same kind of information when choosing the best medications to prescribe for young women. In the United States, the Food and Drug Administration (FDA) is one source of guidance. The FDA looks at the evidence available about the risk of harm if each medication is used during pregnancy. Then it assigns each one to a "Pregnancy Category" (A, B, C, D, or X). The category for each medication is reported in its package insert.
Here's a list of the five FDA categories:
Category Description
A Adequate, well-controlled studies in pregnant women have not shown any risk to the fetus in the first three months of pregnancy, and there's no evidence of later risk either. Very few medications have been tested to this level.
Examples: folic acid, levothyroxine (Synthroid)
B There have been no adequate, well-controlled studies in women but studies using animals have not found any risk to the fetus, or animal studies have found risk that was not confirmed by adequate studies in pregnant women. Not many adequate studies have been performed in pregnant women, so the first situation (not enough information) usually applies if a medication is assigned to this category.
Examples: ondansetron (Zofran), metformin (Glucophage)
C There have been no adequate, well-controlled studies in women, but studies using animals have shown a harmful effect on the fetus, or there haven't been any studies in either women or animals. Caution is advised, but the benefits of the medication may outweigh the potential risks.
Examples: albuterol (Ventolin), sertraline (Zoloft)
D There is clear evidence of risk to the human fetus, but the benefits may outweigh the risk for pregnant women who have a serious condition that cannot be treated effectively with a safer drug.
Examples: paroxetine (Paxil), phenytoin (Dilantin)
X There is clear evidence that the medication causes abnormalities in the fetus. The risks outweigh any potential benefits for women who are (or may become) pregnant.
Examples: isotretinoin (Accutane), warfarin (Coumadin)
This system, while the best now available, could be interpreted as suggesting clear differences between medications in various categories when the differences are really much less distinct. The categorization of many medications is based mainly on lack of evidence one way or the other. The FDA is considering a change to more detailed descriptions that would also include information on fertility and breastfeeding.
几种常见药物：
●Tylenol (Acetaminophen)
Category B - drugs that have been used a lot during pregnancy and do not appear to cause major birth defects or other problems. Tylenol does appear to cross the human placenta. Three studies involving more than 10,000 newborns exposed to acetaminophen during the first trimester did not find an association between acetaminophen and major malformations. Tylenol should not be used over the long term.
●Ibuprofen
Some common brands are Advil and Motrin. This drug is a class B until the 3rd trimester, then it is a class D. Borderline association with gastroschisis.
All NSAIDs used near term may cause premature closure of the ductus arteriosus, and inhibit labor. Oligohydramnios after prolonged use is a common complication with NSAIDs as a class. There are no adequate studies of ibuprofen in pregnant women. Therefore, ibuprofen is not recommended during pregnancy.
●Benadryl (diphenhydramine hydrochloride)
Category B in third trimester. But in the 1st and 2nd trimester Diphenhydramine has been used extensively in pregnant women; the incidence of fetal malformations is the same as that which would be expected in women who are not taking medications. Diphenhydramine may cause uterine irritability or contractions near term when used in high doses (greater than 50mg).
●Sudafed (pseudoephedrine)
Class C in pregnancy. It is recommended that one doesn’t use it because of some associated problems that occur along with gastroschisis are preterm birth, intrauterine growth restriction and cardiac problems. If you feel that you need this or a similar type of drug, please visit you physician.
●Cough Syrup
There are a variety of honey based natural cough syrups on the market and others in drug stores, please read the bottle before using about contraindications.
Check this product's ingredient list for phenylpropanolamine (PPA). The FDA has issued warnings regarding PPA side effects. Do not use if Dextromethorphan is present it is the focus of a recent controversy, following a report that dextromethorphan induced miscarriage and malformations, such as open neural tube defects, in chick embryos injected with dextromethorphan.
Contact your healthcare provider about the specific brand.An increased incidence of inguinal hernias was noted in a retrospective study of 197 women with first trimester exposure to guaifenesin. Other retrospective studies have not, however, found an increased incidence of malformations associated with guaifenesin exposure during the first trimester. Overall, the teratogenic risk of guaifenesin is thought to be low.
●Alka Seltzer (Buffered Aspirin Product)
Class D product for pregnancy. Possible Tetrogenic actions, linked to prolonged gestation, readily crosses the placenta, post partal hemorrhage and linked to low birth weight, increased intracranial hemorrhage, stillbirth and neonatal death.
●Tums (Calcium carbonate)
Class D in pregnancy. Extended heavy use of calcium antacids (20 grams or more daily for a prolonged period) may cause excess calcium in the blood, which can lead to kidney stones and reduced kidney function. People who already have impaired kidneys may develop milk-alkali syndrome (causing symptoms such as nausea, vomiting, mental confusion, and loss of appetite) with as little as 4 grams a day.
●Mylanta (Aluminum and Magnesium Hydroxide w/or without Simethicone)
Class C in pregnancy. There have been sporadic reports of fetal maldevelopment and injury associated with prolonged use of high dosages of aluminum-containing antacids during pregnancy.
★ Some Medications Considered Safe for Use During Pregnancy
http://www.obfocus.com/high-risk/medsprint.htm
■Asthma
Budesonide inhaled or nasal spray (Pulmicort®, Rhinocort ®)
■Bladder infection (UTI)
Nitrofurantoin (Macrobid®)- Avoid in patients with possible G6PD deficiency
■Cough
Dextromethrophan (Robitussin DM sugar free ®)
■Constipation
Metamucil® , Citrucel®,
Docusate (Colace®, Ducolax ®)
Milk of magnesia.
Polyethyelene glycol (Miralax®)
■Diabetes
Insulin
Glyburide (Micronase®)
Metformin (Glucophage®)
■Diarrhea
Loperamide (Imodium A-D ®)
■Gas
Simethicone (Gas-X ®, Mylicon ®, Phazyme ®)
■Gastroesophageal reflux disease (GERD)
Ranitidine (Zantac®)
Cimetidine (Tagamet®)
■Hayfever, sneezing, runny nose, itchy watery eyes
Chlorpheniramine (Chlor-Trimeton ®,Efidac ®, Teldrin ®)
Diphenhydramine (Benadryl ®) Clemastine (Tavist Allergy ®)
■Headache or fever
Acetaminophen (APAP,Paracetamol,Panadol, Tylenol®)
■Heartburn
TUMs®
■Hemorrhoids
Tucks®
Preparation H®
Anusol®
■High blood pressure
Methyldopa (Aldomet®)
■Hyperprolactinemia
Bromocriptine (Parlodel®)
Carbergoline (Dostinex®)
■Hypothyroidism
Thyroid hormone
Levothyroxine (Synthroid ®, Levoxyl ®)
■Infection
Acyclovir (Zovirax ®)
Azthitromycin (Zithromax ®)
Cepaholosporins: Cephalexin (Keflex®), Cefazolin (Ancef ®), cefaclor (Ceclor®), Clindamycin (Cleocin®)
Erythromycin
Penicillins: Amoxicillin (Amoxil®), Amoxicillin Clavulanate (Augmentin®), methicillin, carbenicillin
Metronidazole (Flagyl®)
■Insomnia
Doxylamine(Unisom Sleep Tabs® )
■Motion sickness
Dimenhydrinate (Dramamine ®)
■Nasal congestion
Pseudoephedrine (Sudafed ®): Avoid in first trimester.
■Nasal congestion, sneezing, runny nose, itchy watery eyes
Actifed Cold and Allergy ®: Ingredients-Triprolidine, Pseudoephedrine - Avoid in first trimester.
■Nasal congestion, sneezing, runny nose, itchy watery eyes, fever, and headache
Actifed Cold and Sinus ®: Ingredients-Acetaminophen, Chlorpheniramine, Pseudoephedrine- Avoid in first trimester.
■Nausea
Ginger
Pyridoxine 25 mg PO TID WITH: Unisom Sleep Tabs (Doxylamine Succinate 25 mg) 1/2 tablet TIDMetoclopramide (Reglan ®)
■Preeclampsia
Magnesium sulfate
■Vaginal yeast infection
Clotrimazole cream (Gyne-Lotrimin®)
若要搜索某个药物是否适于准妈妈，请参看这里，也可按字母列表查询(点击“Search”上面的字母)：
http://www.safefetus.com/Search.asp
FDA网站也可以搜索和浏览：
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
其他国家请看这里：
http://en.wikipedia.org/wiki/Pregnancy_category
Over-the-Counter (OTC) Medications
OTC medications do not have pregnancy letter categories unless they were previously a prescription mediation. Your healthcare provider can help you determine which OTC medications may be right for treating your headaches or other medical conditions.
All OTC medicines have a Drug Facts label. The Drug Facts label is arranged the same way on all OTC medicines. This makes information about using the medicine easier to find. One section of the Drug Facts label is for pregnant women. With OTC medicines, the label usually tells a pregnant woman to speak with her doctor before using the medicine. Some OTC medicines are known to cause certain problems in pregnancy. The labels for these medicines give pregnant women facts about why and when they should not use the medicine. Here are some examples:
●Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Advil®, Motrin®), naproxen (Aleve®), and aspirin (acetylsalicylate), can cause serious blood flow problems in the baby if used during the last third of pregnancy (after 28 weeks). Also, aspirin may increase the chance for bleeding problems in the mother and the baby during pregnancy or at delivery.
●The labels for nicotine therapy drugs, like the nicotine patch and lozenge, remind women that smoking can harm an unborn child. While the medicine is thought to be safer than smoking, the risks of the medicine are not fully known. Pregnant smokers are told to try quitting without the medicine first.
★ Medicine and Pregnancy
You still can use many medicines when you are pregnant or nursing. Use this guide and talk to your doctor, nurse, or pharmacist about keeping you and your baby safe.
1、Know the Facts
●If you're not pregnant yet, you can help your chances for having a healthy baby by planning ahead. You can make choices about which medicines to use before you get pregnant. Always talk to your doctor, nurse, or pharmacist first! It's very important that you keep getting treatment for any health problems.
●Your heart and kidneys work harder when you are pregnant. This makes some medicines pass through your body faster than usual. Your doctor might need to give you a higher dose of your medicines or make you take them more often.
●Some drugs can harm your baby during different stages of your pregnancy. At these times, your doctor might tell you to stop taking your regular medicine until it is safe to go back on it. Your doctor may put you on a different medicine that is safer for your baby.
2、Read the Label and Ask Questions
●The law says that all drug labels must list the risks for women who are pregnant or trying to get pregnant.
●Your doctor, nurse, or pharmacist can help you choose the medicines that are right for you.
3、Don't take:
●Aspirin
Don't take aspirin during the last 3 months of your pregnancy, unless your doctor tells you to. Aspirin can cause problems for your baby, or cause problems when you are in labor.
●Ibuprofen (Motrin, Advil)
Like aspirin, it may cause problems during the last 3 months of pregnancy and when you are in labor.
●Products like herbs, minerals, amino acids
No one is sure if these are safe for pregnant women, so it's best not to use them. Even some "natural" products may not be good for women who are pregnant or nursing.
4、Vitamins
●Women who are pregnant should not take regular vitamins. They can contain doses that are too high.
●Ask about special vitamins for pregnant women that can help keep you and your baby healthy.
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