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Rare Cases of Liver Injury Reported with Use of Orlistat (Xenical®)

2013-02-10

Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) ≥ 30 kg/m2 and overweight patients (BMI ≥ 28 kg/m2) with associated risk factors such as type II diabetes, hyperlipidemia and hypertension. Also, Orlistat is indicated in patients who fail to respond adequately to suitable weight reducing measures, orlistat can be used as an adjunct to a hypocaloric diet and physical measures in the treatment of dietary overweight.

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Safety Warning of accidental overdose reported in infants and children with intravenous paracetamol (Perflgan®)

2013-02-10

Dear Healthcare Provider :

Saudi Food and Drug Authority would like to draw the attention of healthcare professionals to the risk of accidental overdose in neonates and infants during treatment with intravenous paracetamol 10 mg/ml solution for infusion which is marketed in Saudi Arabia as PERFALGAN®; available in 100 ml vials. The warning of risk of overdose is based on information available from the company (Bristol Myers Squibb).

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