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Warning Date
    2008-03-08

STRONGER SAFETY WARNINGS FOR THE SLEEP MEDICATION ZOLPIDEM (STILNOX, ZOLPIGEN)

2008-03-08

    Riyadh, March 3, 2008 – The Australian Therapeutic Goods Administration (TGA), that country’s equivalent to the Saudi Food and Drug Authority (SFDA), announce new, stronger safety warning for the sleep medication zolpidem. This drug is sold as Stilnox or Zolpigen in Saudi Arabia.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2008-03-09

Warning has been added to the Prescribing Information of TAMIFLU (oseltamivir phosphate)

2008-03-09

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  • Call Centre 19999


Other Warnings

Warning Date
    2008-03-10

LIVER TOXICITY AND THE USE OF ORAL KETOCONAZOLE (NIZORAL) FOR FUNGAL INFECTIONS

2008-03-10

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  • Call Centre 19999


Other Warnings

Warning Date
    2008-03-22

Health Canada Reminds Consumers not to use Ephedra/Ephedrine Products

2008-03-22

Health Canada, the Canadian equivalent of the Saudi Food and Drug Authority (SFDA), has reminded consumers not to use products containing Ephedra or ephedrine, either alone or in combination with caffeine and other stimulants, for purposes of weight loss, body building or increased energy. Use of products containing Ephedra or ephedrine in combination with caffeine and other stimulants may have serious, possibly fatal, adverse effects Health Canada is advising consumers that these products are not authorized for use.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2008-03-26

INCREASED MORTALITY, CV, THROMBOEMBOLIC EVENTS, AND TUMOR PROGRESSION WITH THE ERYTHROCYTE STIMULATING AGENTS (ESAs) ARANESP, EPREX, RECORMON

2008-03-26

    The U.S. equivalent of the Saudi Food and Drug Authority (SFDA) now requires significantly stronger warnings in the prescribing information for the erythrocyte stimulating agents (ESAs). The ESAs are used in to increase red blood cell production in patients with end stage renal disease and cancer patients. The ESA products approved for sale in Saudi Arabia are Aranesp, Eprex, and Recormon.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2008-03-26

STRONGER WARNINGS ABOUT TUBERCULOSIS (TB) WITH THE ARTHRITIS AND PSORIASIS DRUG ETANERCEPT (ENBREL)

2008-03-26

    The manufacturers of Etanercept (Enbrel), an injectable drug used to treat arthritis and psoriasis, announced that the drug is now required to carry a black box warning about the risk of infections, including tuberculosis (TB), in the drugs U.S. prescribing information. A black box warning is the strongest type of warning that the U.S. Food and Drug Administration (FDA) can require in a drug’s prescribing information. The U.S. FDA has an equivalent function to the Saudi Food and Drug Authority.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2008-04-16

Warning Consumers about "Total Body Formula" and "Total Body Mega Formula"

2008-04-16

    The U.S. Food and Drug Administration (FDA), the American counterpart to the Saudi Food and Drug Authority (SFDA), is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2008-04-20

Use of bisphosphonates among women and risk of atrial fibrillation

2008-04-20

Objective To assess the association between atrial fibrillation and flutter and use of bisphosphonates for osteoporosis among women.

Design Population based case-control study, using medical databases from Denmark.

Setting Northern Denmark.

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  • Call Centre 19999


Other Warnings

Warning Date
    2008-04-23

إعلان تحذيري بشأن منتجات هرمون الاستروجين (Estrogen) المضاف إليها مادة السايبروتيرون (Cyproterone)

2008-04-23

اصدرت وكالة تنظيم الأدوية والمنتجات الصحية البريطانية ( MHRA ) والمماثلة قي أعمالها للهيئة العامة للغذاء والدواء في المملكة العربية السعودية ( SFDA ) إعلان تحذيري في السابع من شهر أبريل من العام 2008م بشأن منتجات هرمون الاستروجين ( Estrogen ) المضاف إليها مادة السايبروتيرون ( Cyproterone ).

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2008-05-07

الهيئة العامة للغذاء والدواء تكشف عن 45مستحضراً عشبياً تحتوي مواد مضرة بالصحة وقد تؤدي للتسمم و ذات إدعاءات مضللة

2008-05-07

خلصت دراسة ميدانية أجرتها الهيئة العامة للغذاء والدواء في مدينة الرياض عن واقع المستحضرات العشبية والصحية في محلات العطارة والأغذية الصحية والتكميلية، وذلك كنموذج للوضع الراهن لتلك المنتجات في المملكة.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

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