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Warning Date
    2007-09-17

Normal Saline Flush Syringes Manufactured By B. Braun Medical Inc. Recalled Due To Presence Of Medical Grade Silicone

2007-09-17

September 15, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), announced important safety information regarding Normal Saline Flush Syringes

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2007-09-22

Recall of a Batch of Baby's Bliss Gripe Water, Apple flavor from US markets

2007-09-22

September 22, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), announced a recall of Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (10/08) is being recalled from the US market due to the presence of Cryptosporidium infection.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2007-09-30

FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products

2007-09-30

September 28, 2007 – The U.S Food and Drug Administration (FDA), equivalents to the Saudi Food and Drug Authority (SFDA), informed healthcare professionals and consumers in USA of its intent to take action against companies that market unapproved prescription products containing hydrocodone.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

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Prexige to be withdrawn in Canada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.

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  • 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.

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  • 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

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