TOPIC 3: FDA Pregnancy Categories

• Category A

  Adequate studies in pregnant women does not have demonstrated risk to fetus in 1st trimester of pregnancy, and no evidence in later trimester.
• Vitamin A

  helps in the development of healthy skin, eyes, and bones
• • Vitamin A
  • Vitamin C
  • Vitamin B6
  • Vitamin B12
  • Iron
  • Vitamin B9 (Folic Acid / Folate) 


  Examples of pre-natal vitamins belonging to Category A
• Vitamin C

  helps in the growth and development of gums, teeth, and bones
• Vitamin B6

  helps form RBC to a mother and child for absorption of nutrients they need.
• Vitamin B12

  helps support RBC production and nervous system
• Iron

  helps the body to make hemoglobin
• Hemoglobin

  a protein that carries oxygen throughout the cells
• 50%

  A pregnant woman increases her blood volume by
• Iron

  important for fetal development to prevent hypoxia
• Vitamin B9 (Folic Acid)

  also known as folate, and helps in the development of the baby’s nervous system and neural tube.
• Vitamin B9

  they are found in green leafy vegetables and citrus fruits.
• Category B

  Adequate studies have not demonstrated a risk to fetus and no adequate studies in pregnant woman. However, animal studies have shown an adverse effect.
• Aluminum Hydroxide (AL-OH)

  an inorganic salt that is used as an ANTACID
• Antacid

  neutralizes stomach acid production
• Tagamet (Cimetidine)

  treatment for GERD, Duodenal Ulcer, Active gastric ulcer, Heartburn, Indigestion, and for GI Bleeding prevention.
• Zantac (Ranitidine)

  used to decrease stomach acid production and treatment for Peptic Ulcer Disease (PUD), GERD, and Zollinger-Ellison Syndrome
• Zantac is given through mouth and injection. Injection may include the muscle and vein
• Imodium (Loperamide)

  acts to decrease the frequency of diarrhea, Inflammatory Bowel Disease, and Short Bowel Syndrome.
• Loperamide

  not recommended if patient‘s stool has blood and mucus, as well as, fever.
• Roxithromycin

  Is a bacterial antibiotic drug, and a semi-synthetic macrolide antibiotic.
• Roxithromycin

  is used to treat Respiratory tract, Urinary, and Soft Tissue Infections.
• Roxithromycin

  derived from Erythromycin, which is a drug that is applied to a newborn baby to prevent blindness, if the mother has STI.
• • Aluminum Hydroxide (AL-OH)
  • Tagamet (Cimetidine)
  • Zantac (Ranitidine)
  • Imodium (Loperamide) 


  Drugs that belong to Category B
• Category C

  Animal studies have shown an adverse effects on the fetus. Inadequate studies on human fetus. The benefits from the use of the drug in pregnant woman may be acceptable despite its potential risks.
• Lomotil

  an anti-diarrheal
• Dextromethrophan

  a cough suppressant that comes in syrup, table, spray, and lozenge.
• Guaifenesin

  acts as an expectorant, to clear airway from mucus
• Sedatives

  for sleep
• • Lomotil
  • Dextromethrophan
  • Guaifenesin
  • Sedatives
• Category D

  Demonstrates an evidence of Human Fetal Risk, but the potential benefits from the use of the drug on pregnant woman may be acceptable despite its potential risk.
• Dilantin (Phenytoin)

  an anti-seizure medication that prevents tonic-clonic seizure and focal seizures
• Fosphenytoin

  an IV Form of phenytoin that is used for status epilepticus, but does not improve with benzodiazepine
• Lithium

  a psychiatric oral medication, and is used to treat Bipolar disorder and other major depressive disorder. Can sometimes reduce the risk of suicide.
• • Aspirin
  • Phenytoin
  • Lithium
  • Chemotherapeutic Drugs


  Drugs that belong in Category D.
• Category X

  Studies in animals and humans demonstrate fetal abnormalities or adverse reactions. Reports indicate evidence of Fetal Risk.
• Statins

  are also known as HMG-Coa reductase inhibitors, that belongs to the lipid-lowering medications which reduces illness and mortality in those who are at high risk for cardiovascular diseases.
• Coumadin (Warfarin)

  is an anti-coagulant drug that prevents blood clotting in conditions such as DVT, Pulmonary Embolism, and Prevents strokes in cases of Atrial Fibrillation, Valvular Heart Disease, and Artificial Heart Valve
• Quinine

  is used to treat malaria and babesiosis
• Malaria is caused by what pathogen

  Protozoan