FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.

Background & Aims

Rebound acid hypersecretion (RAHS) has been demonstrated after 8 weeks of treatment with a proton-pump inhibitor (PPI). If RAHS induces acid-related symptoms, this might lead to PPI dependency and thus have important implications.

Methods

أشارت دراسة جديدة إلى أن انخفاض عدد خلايا الدم الحمراء في الدم ، بغض النظر عن الأمراض الأخرى التي قد تكون موجودة ، هو أحد عوامل الخطر في وفاة المسنين. في هذه الدراسة ، وجد أن فقر الدم يشكل خطر إضافي للوفاة خلال فترة المتابعة الدورية.

كما أشارت دراسات سابقة أن انخفاض عد خلايا الدم الحمراء له علاقة بالوفاة. ولكن لم يتضح ما إذا كان هذا ببساطة يرجع إلى الأمراض المزمنة التي ترافق عادة فقر الدم أو فقر الدم نفسها

إلحاقاً لما تم نشره بــخصــوص عــــلاقة أنسلين قـــــــلارجـــين ( Insulin glargine ) المعروف بالاسم التجاري لانتوس ( Lantus ) بزيادة احتمالية خطر حدوث السرطان و حيث أن الهيئة العامة للغذاء و الدواء تتابع عن كثب كافة المستجدات حول هذا الموضوع و ما تم اتخاذة من قرارات وتوصيات من قبل الهيئات الرقابية العالمية و الجمعيات العلمية الأخرى فإن الهيئة تود إيضاح مايلي:

The U.S. Food and Drug Administration (FDA), the American counterpart to the Saudi Food and Drug Authority (SFDA), notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products.

Information for Healthcare Professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc)



The U.S. Food and Drug Administration, the American counterpart to the Saudi Food

Riyadh 28th August, 2009- The U.S. Food and Drug Administration the equivalent to the Saudi Food and Drug Authority (SFDA) , is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat which is marketed as a prescription product, Xenical , and as an over-the-counter (OTC) product, Alli.

The U.S. Food and Drug Administration (FDA), the American counterpart to the Saudi Food and Drug Authority (SFDA), notified healthcare professionals of an Early Communication regarding an ongoing review of safety issues with Exjade (deferasirox). New safety data suggests there may be a greater number of adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS).