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Warning Date
    2007-10-22

Prexige to be withdrawn in Canada

2007-10-22

October 4, 2007, Health Canada the equivalent of the Saudi Food and Drug Authority (SFDA), announced that it has stopped the sale of the anti-inflammatory drug Prexige (lumiracoxib) in Canada and will cancel the drug's market authorization due to the potential for serious liver-related adverse events

Prexige, a Cox-2 selective inhibitor non-steroidal anti-inflammatory drug, and used for the treatment of the signs and symptoms of osteoarthritis in adults at a maximum daily dose of 100 milligrams (mg).

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2007-10-22

Information for Healthcare professionals about Exenatide (marketed as Byetta)

2007-10-22

October 16, 2007 , The U.S Food and Drug Administration (FDA), equivalents of the Saudi Food and Drug Authority (SFDA), informed healthcare professionals that it received 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2007-10-31

Use of CellCept (mycophenolate mofetil) associated with increased pregnancy loss and congenital malformations

2007-10-31

October, 29th , 2007, US FDA, the American's equivalent to the Saudi Food and Drug Authority (SFDA), Published notification about increased risk of pregnancy loss and increased risk of congenital malformations after using CellCept.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

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.

  • To report sector-related issues

  • Call Centre 19999


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.

  • To report sector-related issues

  • Call Centre 19999


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.

  • To report sector-related issues

  • Call Centre 19999


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).

  • To report sector-related issues

  • Call Centre 19999


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.

  • To report sector-related issues

  • Call Centre 19999


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.

  • To report sector-related issues

  • Call Centre 19999


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.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

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