The Saudi Food and Drug Authority would like to inform the healthcare professionals and the public that after reviewing the safety profile for products containing ambroxol and bromhexine (secretolytic agents of acute and chronic bronchopulmonary diseases), it has been found that these drugs might be associated with rare but severe allergic reactions such as anaphylactic shock.
SFDA welcomed at its Head Office a student delegation from the faculty of Medicine & Pharmacology of Al Majma’ah University, on Tuesday 2/4/1434H.
The Saudi Food and Drug Authority (SFDA) would like to share some recent information regarding use of Diane 35® (cyproterone acetate 2 mg + ethinyl estradiol 35 micrograms). On 30/01/2013, the French medicines agency (ANSM) announced that they decided to suspend the marketing authorisation for Diane 35® and its generics for acne treatment in France within three months. This decision was based on review of known data by the French medicines agency.
The European Committee for Medicinal Products for Human Use (CHMP) has
reviewed the risk of nephrogenic systemic fibrosis (NSF) with gadolinium containing
contrast agents.
On the basis of current evidence, the risk classification is as follows:
High risk—Omniscan (gadodiamide), OptiMARK (gadoversetamide),Magnevist (gadopentetic acid)
Medium risk—MultiHance (gadobenic acid), Primovist (gadoxetic acid),
Vasovist (gadofosveset)
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.
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).
