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Review Prenatal Safety Reports submitted to FDA

Total Prenatal reports: 7.
Prenatal FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 1.
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FDA Reported Prenatal Side Effects: polydactyly, stillbirth, neonatal aspiration, foetal heart rate decreased, small for dates baby, respiratory arrest, premature baby, placental insufficiency, foetal distress syndrome, coarctation of the aorta, aorta hypoplasia.
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Prenatal Side Effects Report #5644156-1
Consumer or non-health professional from UNITED STATES reported PRENATAL problem on Feb 12, 2008. Female patient was diagnosed with prenatal care and was treated with PRENATAL. After drug was administered, patient experienced the following problems/side effects: congenital anomaly, pregnancy, spina bifida. PRENATAL dosage: unknown. Patient recovered.

Prenatal Side Effects Report #5594048-1
PRENATAL problem was reported by a Consumer or non-health professional from GERMANY on Jan 02, 2008. Female patient, 44 years of age, was treated with PRENATAL. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction, skin test positive. PRENATAL dosage: unknown. Patient recovered.

Prenatal Side Effects Report #5503294-4
Consumer or non-health professional from UNITED STATES reported PRENATAL problem on Oct 18, 2007. Female patient, weighting 7.69 lb, was treated with PRENATAL. After drug was administered, patient experienced the following problems/side effects: no adverse reaction. PRENATAL dosage: unknown. During the same period patient was treated with FOLIC ACID, BETAFERON, CALCIUM, CENTRUM. Patient recovered.

Prenatal Side Effects Report #5410116-9
PRENATAL problem was reported by a Physician from UNITED STATES on July 31, 2007. Female patient, weighting 7.69 lb, was treated with PRENATAL. After drug was administered, patient experienced the following problems/side effects: polydactyly, pregnancy. PRENATAL dosage: unknown. During the same period patient was treated with FOLIC ACID, BETAFERON. Patient recovered.

Prenatal Side Effects Report #5415940-4
Physician from UNITED STATES reported PRENATAL problem on Aug 03, 2007. Female patient, weighting 7.69 lb, was treated with PRENATAL. After drug was administered, patient experienced the following problems/side effects: polydactyly. PRENATAL dosage: unknown. During the same period patient was treated with FOLIC ACID, BETAFERON, CALCIUM CHLORIDE, CENTRUM. Patient recovered.

Prenatal Side Effects Report #5322323-4
PRENATAL problem was reported by a Physician from on May 01, 2007. Female patient, weighting 3.50 lb, was diagnosed with obsessive-compulsive disorder and was treated with PRENATAL. After drug was administered, patient experienced the following problems/side effects: aorta hypoplasia, coarctation of the aorta, dacryostenosis acquired, foetal distress syndrome, placental insufficiency, premature baby, respiratory arrest, small for dates baby. PRENATAL dosage: unknown. During the same period patient was treated with DIGOXIN, LASIX, PROZAC. Patient recovered.

Prenatal Side Effects Report #5296445-0
Consumer or non-health professional from UNITED STATES reported PRENATAL problem on Apr 04, 2007. Male patient was diagnosed with labour induction, feeling of relaxation and was treated with PRENATAL. After drug was administered, patient experienced the following problems/side effects: foetal heart rate decreased, neonatal aspiration, stillbirth. PRENATAL dosage: unknown. During the same period patient was treated with AMBIEN. Patient was hospitalized. Patient died on 04/05/2005.


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congenital anomaly, pregnancy, spina bifida, anaphylactoid reaction, skin test positive, no adverse reaction, , was diagnosed with prenatal care and was diagnosed with obsessive-compulsive disorder and was diagnosed with labour induction, feeling of relaxation and