On February 8, 2008, The U.S. Food and Drug Administration (FDA), the American equivalent of the Saudi Food and Drug Authority (SFDA), issued a warning based on reports of adverse reactions including respiratory compromise and death following the use of botulinum toxins approved and unapproved uses. The reactions occurs when botulinum toxin spreads in the body beyond the site where the drug was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy associated limb spasticity.

Background

    February 29, 2008 – The U.S Food and Drug Administration (FDA), the equivalents of the Saudi Food and Drug Authority (SFDA), announced that the Biogen ldec and Elan the manufacturer of TYSABRI" (natalizumab),a medicine used to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the number of relapses, has notified healthcare professionals that the full Prescribing Information has been revised to add to the Warnings and Precautions section informatio

    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.

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.

    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.

    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.

    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.