The Australian Therapeutic Goods Administration (TGA), the Australian equivalent to the Saudi Food and Drug Authority (SFDA), has recently published the February 2008 issue of the Australian Adverse Drug Reactions Bulletin which included a topic titled  “Hepatic reactions with Terbenafine”.

Oral Terbenafine, marketed as (Lamisil) or (Lamifen) was approved in Saudi Arabia in 2002 as a treatment of fungal infections of the nails and skin (ringworm) that are not responsive to topical therapy.

On January 31, 2008, the U.S. Food and Drug Administration (FDA) , the American equivalent to the Saudi Food and Drug Authority (SFDA), released a safety information about antiepileptic drugs. Antiepileptic drugs may be associated with an increased risk of suicidal behavior and suicidal ideation.

On February 1, 2008, The U.S Food and Drug Administration (FDA), the equivalent of the Saudi Food and Drug Authority (SFDA), has issued an alert to highlight important revisions to the warnings and precautions sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix.

Prescrire International, a highly regarded French drug bulletin, published a review of psychiatric adverse effects associated with the use of Fluoroquinolone antibiotics in their February 2008 issue. The review is based 590 psychiatric adverse reactions reported to the Bordeaux Regional Pharmacovigilance Centre between 1985 and 2002.

Overall, 7.4% of the reports involved a psychiatric adverse effect with a Fluoroquinolone compared to 2.6% for all other antibiotics combined. There were approximately 38,000 reports in total.

On February 6, 2008, the U.S. Food and Drug Administration (FDA), the American  equivalent to the Saudi Food and Drug Authority (SFDA), announced its intention to take enforcement action against companies marketing unapproved, injectable Colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death.

On February 07, 2008,  Health Canada, the Canadian equivalent to the Saudi Food and Drug Authority (SFDA), adviced consumers not to use the following products listed in the table below due to concerns about possible side-effects.

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace. However, it is possible these products could be purchased by Canadians travelling abroad or have been brought into Canada through personal importation by travelers or purchased over the Internet.

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.