PREGNANCY MULTIVITAMIN FOLIC

Adverse Drug Reaction Overview Allergic sensitization has been reported following both oral and parenteral administration of folic acid. g. 17, 18, 19 Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. m. m. 20 An equal number of pregnant women suffering from nausea and vomiting of pregnancy (NVP) and pregnant women without NVP were randomized to receive either vitamin- mineral supplement tablets for prenatal/postpartum use or a supplement with high iron content for one month.

The primary end point of interest was the mean rate of adverse events including decreased compliance. The mean rate of adverse events was collected for nausea, constipation and other adverse drug events and is illustrated in Table 2.

20 Pregnancy Multivitamin Folic 5 Product Monograph Page 8 of 32 Table 2 - Overall Study Results, Comparing vitamin-mineral supplement tablets for prenatal/postpartum use (Low Iron) to a Supplement with a High Iron Content over a Month Administration in a Cross-Over Design.

) tablet] separately on two different occasions. 9 Abnormal Hematologic and Clinical Chemistry Findings None reported. 1 mg vs. 5 mg). 22, 23 Reactions are presented by MedDRA System Organ Class (SOC) and Preferred Terms (signs, symptoms and diagnosis) from spontaneous notification.

Pregnancy Multivitamin Folic 5 Product Monograph Page 9 of 32 Table 3 - Cumulative Summary of Adverse Reactions from Post-Marketing Spontaneous Reporting Systems for vitamin-mineral supplement tablets for prenatal/post-partum use and vitamin-mineral supplement tablets high dose folic acid for prenatal use (5 mg) as of September 30, 2008.

MedDRA Preferred Term Vitamin-mineral supplement tablets for prenatal/postpartum use Vitamin-mineral supplement tablets high dose folic acid for prenatal use Spontaneous Reports SOC: Eye disorders (n=2) Eye pruritus 1 0 Visual impairment 0 1 SOC: Gastrointestinal disorders (n=45) Nausea 10 4 Vomiting 8 1 Constipation 3 0 Diarrhea 3 0 Stomach discomfort 2 1 Abdominal pain upper 2 0 Dyspepsia 2 0 Abdominal distension 1 1 Infrequent bowel movement 1 1 Cheilitis 1 0 Heartburn 1 0 Lip dry 1 0 Retching 1 0 Abdominal pain lower 0 1 SOC: General disorders and administration site conditions (n=7) Feeling abnormal 2 0 Asthenia 1 0 Fatigue 1 0 Hunger 1 0 Pyrexia 1 0 Thirst 1 0 SOC: Metabolism and nutrition disorders (n=4) Decreased appetite 2 0 Dehydration 1 0 Hyperglycemia 1 0 Pregnancy Multivitamin Folic 5 Product Monograph Page 10 of 32 Table 3 - Cumulative Summary of Adverse Reactions from Post-Marketing Spontaneous Reporting Systems for vitamin-mineral supplement tablets for prenatal/post-partum use and vitamin- mineral supplement tablets high dose folic acid for prenatal use (5 mg) as of September 30, 2008.

(cont’d) SOC: Musculoskeletal and connective tissue disorders (n=1) Myalgia 1 0 SOC: Nervous system disorders (n=5) Headache 1 1 Dizziness 1 0 Lethargy 1 0 Migraine 0 1 SOC: Pregnancy, puerperium and perinatal conditions (n=2) Vomiting in pregnancy 2 0 SOC: Psychiatric disorders (n=4) Insomnia 2 1 Nervousness 1 0 SOC: Renal and urinary system disorders (n=5) Chromaturia 3 2 SOC: Respiratory and thoracic […]