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Warning Date
    2007-11-20

EMEA adds warnings in the prescribing information of Strontium Ranelate (Protelos)

2007-11-20

On November 16, 2007, the European Medicine Agency (EMEA), the European's equivalent to the Saudi Food and Drug Authority (SFDA), agrees on the inclusion of warnings concerning the risk of severe hypersensitivity reactions in the prescribing and patient information for strontium ranelate, as an urgent measure .

Strontium ranelate (Protelos) is used for treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.

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Other Warnings

Warning Date
    2007-11-28

Use of intravenous magnesium to treat acute onset atrial fibrillation

2007-11-28

The objective was To assess the effects of intravenous magnesium on converting acute onset atrial fibrillation to sinus rhythm, reducing ventricular response and risk of bradycardia.

It was a randomised controlled trials evaluating intravenous magnesium to treat acute onset atrial fibrillation from MEDLINE (1966 to 2006), EMBASE (1990 to 2006) and Cochrane Controlled Trials Register without language restrictions. Review methods two researchers independently performed the literature search and data extraction.

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Other Warnings

Warning Date
    2008-01-05

US FDA: Dangerous Or Fatal Skin Reactions In Patients With A Particular Human Leukocyte Antigen following Carbamazepine therapy

2008-01-05

12th December 2007, FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians.

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Other Warnings

Warning Date
    2008-01-09

SEVERE BONE, JOINT AND/OR MUSCLE PAIN WITH THE POPULAR BISPHOSPHONATE DRUGS USED TO TREAT OSTEOPOROSIS

2008-01-09

January 7, 2008 – The U.S. FDA, the equivalent of the Saudi Food and Drug Authority issued an alert on the possibility of severe and sometimes incapacitating bone, joint, and/or muscle pain in patients receiving the bisphosphonate class of drugs. These drugs are used widely to treat postmenopausal osteoporosis.

The bisphosphonate currently approved to be sold in Saudi Arabia are: alendronate (Fosamax); disodium pamidronate with solvent for infusion (Aredia); and zoledronic acid (Zometa).

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Other Warnings

Warning Date
    2008-01-20

Serious Safety concerns with the use of Edetate Disodium

2008-01-20

January 16, 2008 – The U.S Food and Drug Administration (FDA), the equivalent of the Saudi Food and Drug Authority (SFDA), notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA.

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Other Warnings

Warning Date
    2008-02-06

Hepatic Reactions with Terbenafine

2008-02-06

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.

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Other Warnings

Warning Date
    2008-02-06

Suicidality and Antiepileptic Drugs; An FDA Alert

2008-02-06

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.

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Other Warnings

Warning Date
    2008-02-06

Serious neuropsychiatric symptoms experienced in patients taking Chantix™

2008-02-06

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.

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Other Warnings

Warning Date
    2008-02-06

Fluoroquinolone Antibiotics & Psychiatric Adverse Drug Reactions

2008-02-06

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.

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Other Warnings

Warning Date
    2008-02-12

U.S. FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine

2008-02-12

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.

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Other Warnings

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