Pregnancy Category; FDA Pregnancy Risk Category Index

Pregnancy category

Pregnancy category of medication is an assessment of the risk of fetal injury due to the pharmaceutical if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk. In 2015 the FDA replaced the former pregnancy risk letter categories with new information to make them more meaningful.

Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy and did so using a limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled “Intravenous Additives”. However, information that was previously available in the former Appendix 4 (pregnancy) and Appendix 5 (breastfeeding) is now available in the individual drug monographs

pregnancy-category

Your body goes through various changes, both from the inside and out, during the nine months you carry your baby. The hormone levels in your body go up while the immune system is suppressed to prevent your body from refusing the baby as a harmful foreign object. This naturally makes you more prone to various common disorders and infections. However, the regular medicines used for treating common ailments, like cough and cold, are not always safe to be taken during pregnancy.

You are responsible for providing your baby with all the nourishment he needs through the placenta. Now, some medicines may cross the placenta and reach the baby’s bloodstream, leading to various birth defects and complications. Due to this reason, the FDA has categorized all drugs and medicines into five categories depending on their potentially harmful effects on the mother and baby.

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The FDA Pregnancy Category Chart

Pregnancy Category A

 Adequate research has been done with the conclusion that drugs in this category are not likely to cause any harm to the fetus in the first trimester as well as later in pregnancy.

Pregnancy Category B

 Studies carried out on animals have shown no adverse effects on the fetus; however, there is a lack of controlled studies on human pregnancy.

Pregnancy category C

 Animal studies have shown evidence of harmful effects on the fetus; however, no controlled study has been done on a human pregnancy. The medicines may be prescribed in cases where the potential benefits outweigh the possible adverse effects.

Pregnancy category D

 Studies done on human pregnancy have shown positive risks to the fetus. However, doctors might prescribe them in certain cases where the potential benefits outweigh the risks.

Pregnancy category X

 Both human and animal studies have shown positive risks to the fetus, with the adverse effects extending to serious birth defects, miscarriage and fetal death. The possible risks of using these medicines outweigh any potential benefits.

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List of POSSIBLY SAFE medications during pregnancy

pregnancy-category

It is recommended to consult your doctor or midwife before using even the safe over-the-counter medicines as your body may respond differently to them during pregnancy.

Thyroid medicationWesthroid, Armour Thyroid (thyroid desiccated)Category A no serious side effects have been reported apart from hair loss in some individuals


pregnancy-categoryMedicines to Avoid during pregnancy

pregnancy-category

 

pregnancy-category

Australis

Australia has a slightly different pregnancy category system from the United States – notably the subdivision of Category B. (For drugs in B1, B2 and B3 categories, human data are lacking or inadequate. Subcategorisation is based on animal data, and allocation of a B category does not imply greater safety than C category). The system, as outlined below, was developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant. Being general in nature it is not presented as medical advice to health professionals or the public.


Pregnancy Category Australian categorization system for prescribing medicines in pregnancy
A Drugs which have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
B1 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
B2 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
B3 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
C Drugs which, owing to their pharmaceutical effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible.
D Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
X Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

Germany

Category Group Description
Group 1 Extensive human tests and animal studies have not shown the drug to be embryotoxic/teratogenic.
Group 2 Extensive human tests of the drug have not shown the drug to be embryotoxic/teratogenic.
Group 3 Extensive human tests of the drug have not shown the drug to be embryotoxic/teratogenic. However, the drug appears to be embryotoxic/teratogenic in animals.
Group 4 No adequate and well-controlled studies of the drug’s effects on humans are available. Animal studies have shown no embryotoxic/teratogenic effects.
Group 5 No adequate and well-controlled studies of the drug’s effects on humans are available.
Group 6 No adequate and well-controlled studies of the drug’s effects on humans are available. Animal studies have shown embryotoxic/teratogenic effects.
Group 7 There is a risk that the drug is embryotoxic/teratogenic in humans, at least in the first trimester.
Group 8 There is a risk that the drug is toxic to fetuses throughout the second and third trimesters.
Group 9 There is a risk that the drug causes prenatal complications or abnormalities.
Group 10 There is a risk that the drug causes hormone specific action on the human fetus.
Group 11 There is a known risk that the drug is a mutagen/carcinogen.

 In Bangladesh Pregnency Catagory Index

আমরা ডাক্তারী করতে গিয়ে অনেক সময় প্রেগন্যান্ট মাদারদের ড্রাগ প্রেসক্রাইব করতে ভয় পাই।কারণ আমরা জানি অধিকাংশ ড্রাগ প্রেগন্যান্সির জন্য ক্ষতিকর!! এই প্রবলেমের কথা মাথায় রেখে আমি US FDA র দেয়া pregnancy index থেকে প্রেগন্যান্সির সময়ে কি ড্রাগ দেয়া যাবে বা যাবে না।সেটার একটা লিস্ট দেয়ার চেষ্টা করছি৷আগে চলুন প্রেগন্যান্সি ক্যাটাগরি গুলো জেনে নেই।US FDA প্রেগন্যান্সির সময় ড্রাগ প্রেসক্রাইবের ক্ষেত্রে ৬টা ক্যাটাগরিতে ভাগ করেছে – ……………………………………………………
১) Category A :
এই ড্রাগ গুলো প্রেগন্যান্ট মাদারের উপর ডিরেক্ট স্টাডি করে দেখা ফিটাসের উপর এর কোন ক্ষতিকর রিস্ক নাই ৷
২) Category B :
এই ক্যাটাগরির ড্রাগ গুলো কোন হিউম্যান ট্রায়াল হয়নি কিন্তু এনিম্যাল ট্রায়েলে ফিটাসের উপর কোন ক্ষতিকর প্রভাব দেখা যায়নি ৷এই ক্যাটাগরির ড্রাগও নিশ্চিন্তে দেওয়া যাবে প্রেগন্যান্ট মাকে ৷৷
৩)Category C :
এই ক্যাটেগরির ড্রাগ গুলো এনিম্যাল স্টাডিতে এ্যাডভার্স ইফেক্ট পাওয়া গেছে.(টেরাটোগেনিক / এমব্রায়োডাল/অন্যকিছু) ৷ কিন্তু এই ড্রাগ গুলো নিয়ে কোন হিউম্যান ট্রায়াল নাই ৷ রিস্ক বেনিফিট রেশিও হিসেব ছাড়া প্রেসক্রাইব করা ঠিক হবে না
৪) Category D :
এই ক্যাটাগরির ড্রাগ গুলো হিউম্যান ফিটাল রিস্কের ডিরেক্ট এভিডেন্স খুজে পাওয়া গেছে , কিন্তু প্রেগন্যান্ট মাদারের লাইফ বাঁচাতে অন্য কোন অল্টারনেটিভ ড্রাগ পাওয়া না গেলে এটা দেয়া একসেপটেবল ৷
৫) Category X : এই ড্রাগ গুলো সম্পূর্ণ রুপে টেরাটোজেনিক ৷৷
৬) Category N: এই ড্রাগ নিয়ে এখনো কোন হিউম্যান অর এ্যানিম্যাল ট্রায়াল হয়নি ৷৷ চলুন এবার প্রচলিত ড্রাগ গুলোর প্রেগন্যান্সি ক্যাটেগরি দেখি–
*Vitamines:
———–
1)Thiamine HCl …………………………A
2)Folic acid………………………………..A

*Anti-hypersensive:
——————–

1)Atenolo…………………………………..D

2)Misoprostol…………………………….X
3)Losartan ……………………………….C
4) losartan +Thiazide ……………C+D

*Anti-platelets:
———————-
1)Clopidogrel ……………………………..B

2)Clopidogrel+Aspirin …………….B+D

*Anti-histamin:
—————
1)Ketotifen ………………………………..C
2)cetirizine …………………………………B
13)Ambroxol HCl ……………………….N

*Anti-Bacterial:
————–
1)Penicillin ……………………………….B
2)Amoxicillin …………………………….B
3)Co amoxiclav………………………….B
4)Flucloxacillon …………………………B
5)Meropenem ……………………………B
(All penicillins are ..category
6)All cefalosporins are ……………….B

7)Ciprofloxacin…………………………..C

8)ofloxacin…………………………………C

9)Levofloxacin……………………………C
10) Moxifloxacin ………………………..C
11) Lomefloxacin ……………………….C
12) Gatifloxacin…………………………..C
13) Sparfloxacin …………………………C
14) Gemifloxacin ………………………..C
15) Nalodixic Acid ………………………C
16) Chloramphenicol (even drop)…C
18) Tetracyclines………………………..D
19) Clindamycin …………………………B
20)Azithromycin ………………………..B

21)Erythromycin…………………………B

22)Clarithromycin……………………….C
23)Gentamicin …………………………..C
24)Neomycin ……………….topical …C
25)Metronidazole ……………………….B
26) Sulfonamides……………………….D
27) Rifampicin ……………………………C
28) Dapsone……………………………….C
29) INH……………………………………….C

30)Pyraziname……………………………C
31)Ethambutol …………………………..B
32)Streptomycin ……………………….D

*Anti Fungal :
————-
1)Fluconazole ……………………………C 2)

Ketoconazole…………………………..C 3)

Itraconazole…………………………….C 4)

Miconazole………………………………C
5)Nystatin ………………………………….C

6) Clotrimazole…………………………….C
7)Amphotericin B ……………………….B

*Anti Viral :
————
1)Acyclovir ………………………………..B
2)Valacyclovir ……………………………B

3)Adefovir…………………………………..C
4)Lamivudine …………………………….C
5)Zidovudine ……………………………..C
6)Nelfinavir ………………………………..B
7)Abacavir …………………………………C*

Anti protozoal :
—————-
1) Nitazoxanide………………………….B

2)Artemether………………………………D

3)Lumefantrine…………………………..D
4) Quinine…………………………………..C
5)chloroquine …….(may be safe)…N*

Anti Helminthic :
——————
1) Albendazole …………………………..C 2)

Mebendazole…………………………..C
3) Pyrantel pamoate……………………C*

Anti Ectoparasite :
——————–
1) Permethrin……….topical …………B*

Anti-Ulcerant :
—————-
1)Ranitidine…………………………..B 2)

Omeprazole………………………..C
3)Pantoprazole …………………….B

4)Rabiprazole………………………..B
5)Lansoprazole …………………….B
6)Esomeprazole Mg ………………B
7) esomeprazole strontium…….C
8)Antacids(Calcium carbonate) ..C
9)Almunium hydroxide ……………. N 10)

Mg(OH)2………………………………N
11) Simethicone ……………………….C
12) Sucralfate …………………………..B

*Anti Spasmodic :
——————-
1)Tiemonium methylsulphate……….N
2)Dotaverine ………………………………C
3) Tramadol HCl………………………….C

*Laxative :
———–
1)Lactulose ………………………….B

*Nausea, Vomiting and Vertigo :
——————————–
1)Cinnarone …………………………..C
2)Meclizine …………………………… B
3)Meclizine + pyridoxine …………B
4)Prometazine ………………………..C
5)Cyclizine ………………………………B

6)Doxylamine…………………………..B

*Severe Vomiting :
——————
1)Domperidone —————–N
2)Ondansetron …………………………B
3)Granisetron …………………………..B
4) Palonosetron………………………..B
*NSAIDs :
———-
1)Paracetamol ……………………….B
2)Aspirin ……………………………….C+D
3)Aceclofenac ………………………..N
4)Diclofenac …………………………..C+D
5)Ibuprofen ……………………………C+D

6)Indomethacin………………………C+D
7)Naproxen ……………………………C

8)Ketorolac…………………………….C
9)Meloxicam ………………………….C+D
10)Sulindac ……………………………..C
11)Etoricoxib ……………………………N
*DMARDs :
———-
1)Methotrexate ………………………..X
2)Azathioprime ………………………..D
3)Salfasalazine ……………………….B
4)Leflunomide …………………………X
*Muscle Relaxant :
——————
1)Beclofen …………………………….C
2)Tolperisone ………………………..N
3)Eperisone …………………………..N

4)Tizanidine…………………………..C
*Anti cancer Drugs :
——————-
1)Actinomycin………………………..D
2)Busulfan. ……………………………D

3)Chlorambucil………………………D

4)Cyclophosphamide……………..D

5)Doxorubicin………………………..D

6)Mercaptopurine…………………..D

7)Methotrexate………………………X

8)Vinblastine………………………….D

9)Vincristine…………………………..D
(C+D মানে, এই ড্রাগ গুলো এক ট্রাইমেস্টারে Category C তে আর এক Trimester এ ক্যাটেগরি D তে)

[A= নিশ্চিন্তে প্রেসক্রাইব করা যাবে৷ B= প্রেসক্রাইব করা যাবে৷
C= রিস্ক বেনিফিট রেশিও হিসেব করে প্রেসক্রাইব করতে হবে (এই ঔষধ বাচ্চার ও প্রেগিন্যান্সির জন্য ক্ষতিকর)৷
D= সুস্থ্য বাচ্চা ও প্রেগন্যান্সি চাইলে প্রেসক্রাইব করা যাবেনা (শুধু মাত্র মায়ের জীবন বাঁচানোর মত কন্ডিশন আসলে যেখানে অল্টারনেটিভ নাই সেখানে দেয়া যাবে)৷ X = ক্রস মার্ক, দেয়া যাবেনা৷৷] ক্যাটাগরি C তে প্রেগনেন্সি রিলেটেড যে প্রবলেমেগুলো হতে পারে — spontaneous abortions, delayed onset
of labor, premature closing of the
fetal ductus arteriosus, jaundice,
occasionally maternal (intrapartum
and postpartum) and/or neonatal
hemorrhage, necrotizing enterocolitis,
and oligohydramnios.
ক্যাটাগরি D তে যে প্রবলেমগুলো হবে— Congenital malformations (eg, fetal
growth restriction, mandibular
hypoplasia, cleft palate,cranial
dysostosis, spinal defects, ear defects, clubfoo.


References

pregnancy category