Sex: F
Vaccine: COVID19, FLUX, PPV, TDAP
Symptoms: Low birth weight baby, Neonatal lupus erythematosus, Prenatal screening test, Rash, Thrombocytopenia
Clinical narrative: drug expoure in utero; rash on her trunk, arms and legs; neonatal lupus erythematosus; thrombocytopenia; tested positive for X-linked adrenoleukodystrophy; Body weight was 1502 gm; This serious prospective pregnancy case was reported by a other health professional via Regulatory Authority and described the occurrence of neonatal lupus erythematosus in a female patient exposed to belimumab solution for injection in utero. The mother received the product for lupus nephritis.   The parent's medical history included blood pressure high, chronic kidney disease, lupus nephritis, neuropathy, osteopenia, seborrheic dermatitis, sjogren's and systemic lupus erythematosus.   On 15-NOV-2017, the mother started belimumab (subcutaneous) 200 mg weekly. On 15-OCT-2022, the mother received Flu vaccine (intramuscular). On 12-JAN-2023, the mother received Tdap Vaccine (intramuscular). On 13-JUN-2022, the mother started acyclovir (oral) 800 mg daily (800 mg daily). On 13-JAN-2022, the dose was changed to 1200 mg daily (1200 mg daily). On 13-JUN-2022, the mother started amitriptyline (oral) 10 mg daily (10 mg daily), Aspirin (oral) 162 mg daily (162 mg daily), calcium (oral) 600 mg twice a day (1200 mg daily). On 01-JUL-2002, the mother started hydroxychloroquine sulfate (oral) 400 mg daily (400 mg daily). On 13-JUN-2022, the mother started labetalol (oral) 400 mg daily (400 mg daily). On 10-DEC-2022, the dose was changed to 300 mg daily (300 mg daily). On 13-JUN-2022, the mother started magnesium 131 mg daily (131 mg daily). On 01-OCT-2022, the mother started Covid-19 Vaccine Moderna (intramuscular). On 13-JUN-2022, the mother started nifedipine (oral) 90 mg daily (90 mg daily). On 10-OCT-2022, the mother started nitrofurantoin (oral) 100 mg daily (100 mg daily). On 13-JUN-2022, the mother started Omega 3 Fish Oil (oral) 1280 mg daily (1280 mg daily) and omeprazole (oral) 20 mg daily (20 mg daily). On 10-JUN-2022, the mother started Pneumococcal Polysaccharide Vaccine (intramuscular). On 07-JAN-2001, the mother started prednisone (oral) 10 mg daily (10 mg daily). On 30-NOV-2022, the mother started Tums (oral) 1 dosage form(s) daily (1 dosage form(s) daily). On 13-JUN-2022, the mother started Vitamin D3 (oral) 5000 iu daily (5000 iu daily). Belimumab was discontinued on 12-FEB-2023. Acyclovir was discontinued on 12-FEB-2023. Amitriptyline was discontinued on 12-FEB-2023. Aspirin was discontinued on 12-FEB-2023. Calcium was discontinued on 12-FEB-2023. Hydroxychloroquine sulfate was discontinued on 12-FEB-2023. Labetalol was discontinued on 12-FEB-2023. Magnesium was discontinued on 12-FEB-2023. Nifedipine was discontinued on 12-FEB-2023. Nitrofurantoin was discontinued on 12-FEB-2023. Omega 3 Fish Oil was discontinued on 12-FEB-2023. Omeprazole was discontinued on 12-FEB-2023. Tums was discontinued on 12-FEB-2023. Vitamin D3 was discontinued on 12-FEB-2023. The patient was diagnosed with thrombocytopenia (Verbatim: thrombocytopenia) (serious criteria GSK medically significant and other: Serious as per reporter). On 14-FEB-2023, the patient experienced neonatal lupus erythematosus (Verbatim: neonatal lupus erythematosus) (serious criteria GSK medically significant, congenital anomaly and other: Serious as per reporter). On 14-MAR-2023, the patient experienced generalized rash (Verbatim: rash on her trunk, arms and legs). In 2023, the patient experienced adrenoleukodystrophy (Verbatim: tested positive for X-linked adrenoleukodystrophy) and birth weight low (Verbatim: Body weight was 1502 gm). On an unknown date, the patient experienced drug exposure in utero (Verbatim: drug expoure in utero). The outcome of the thrombocytopenia, neonatal lupus erythematosus, generalized rash, adrenoleukodystrophy and birth weight low were not reported and the outcome of the drug exposure in utero was unknown.   It was unknown if the reporter considered the neonatal lupus erythematosus, thrombocytopenia, generalized rash, adrenoleukodystrophy and birth weight low to be related to belimumab, Flu vaccine and Tdap Vaccine.     The company considered the neonatal lupus erythematosus and thrombocytopenia to be unrelated to belimumab. It was unknown if the company considered the generalized rash, adrenoleukodystrophy and birth weight low to be related to belimumab, Flu vaccine and Tdap Vaccine. It was unknown if the company considered the neonatal lupus erythematosus and thrombocytopenia to be related to Flu vaccine and Tdap Vaccine.   Pregnancy exposure: Pregnancy Exposure (belimumab): To mother before conception during all trimesters Last Menstrual Period Date: 13-JUN-2022 Estimated Delivery/Due date: 20-MAR-2023  Pregnancy Details (Neonate 1):  Actual Delivery Date: FEB-2023 Gestation Time at Delivery: 34 weeks and 6 days Delivery Type: cesarean Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Birth Weight: 1503 grams (3lbs 5oz)   See case US2023AMR055124 for details regarding the mother case.   GSK Receipt Date: 12-APR-2023 Co suspect included Prenatal vitamin (1 pill, once a day) for pregnancy. Woman enrolled in the pregnancy registry prospectively with pregnancy exposed to Benlysta. She delivered a liveborn infant. Participant reported to that the baby was diagnosed with thrombocytopenia at birth and required blood transfusion. On approximately 14-Mar-2023 the baby developed a rash on her trunk, arms and legs neonatal lupus erythematosus was suspected. Evaluation by dermatology and rheumatology was planned. Also the baby tested positive for X-linked adrenoleukodystrophy on newborn screening. It was unknown if the reporter considered the neonatal lupus erythematosus, thrombocytopenia, generalized rash, adrenoleukodystrophy and birth weight low to be related to Acyclovir, amitriptyline, Aspirin, calcium, Coffee, hydroxychloroquine sulfate, labetalol, magnesium, Covid-19 Vaccine, Nifedipine, Nitrofurantoin, Omega 3 Fish Oil, omeprazole,  Pneumococcal Polysaccharide Vaccine, Vitamin D3. Other exposure included Glucose Tolerance test preparation on 15 Dec 2022 and 11 Oct 2022 (normal). Co suspect included coffee (oral) daily. Coffee was discontinued on 12-FEB-2023.; Sender's Comments: Neonatal lupus erythematosus and Thrombocytopenia are unlisted events which are considered unrelated to GSK drug Belimumab. US-GSK-US2023AMR055124:mother case