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Rosuvastatin in Older Patients with Systolic Heart Failure

2007-12-08

Patients with systolic heart failure have generally been excluded from statin trials. Acute coronary events are uncommon in this population, and Statins have theoretical risks in these patients.


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SAFETY UPDATE ON PAIN MEDICATION (TRAMADOL)

2007-12-10

December 5, 2007 – New Zealand’s Centre for Adverse Reactions Monitoring (CARM), the counterpart to the Saudi Food and Drug Authority’s Pharmacovigilance Center, issued a safety update about the pain medication tramadol and association with increased risk of a serious adverse drug reaction know as serotonin syndrome. In addition, the safety update notes an increased risk of seizure with the use of tramadol.

Sign and symptoms of the serotonin syndrome are listed below:

mental status changes (confusion, mild degree of mania)


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US FDA Updates Desmopressin Acetate Prescribing Information

2007-12-12

December 04, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), has requested the manufacturers update the prescribing information for desmopressin to include important new information about severe hyponatremia and seizures.


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FDA Updates Fentanyl Transdermal Patches Prescribing Information

2007-12-31

In December 21, 2007, the Food and Drug Administration (US FDA), the equivalent to the Saudi Food and Drug Authority (SFDA), updated an important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system.

The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant.


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Association between tetracycline or doxycycline and hepatotoxicity

2008-01-05

An FDA Working Group, along with representatives of PhRMA and the American Association for the Study of Liver Diseases, as well as the Institute of Medicine.


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TESTOSTERONE SUPPLEMENTATION OF LITTLE OR NO BENEFIT IN HEALTH OLDER MEN

2008-01-05

January 5 , 2008 – Research published in the January 2, 2008 Journal of the American Medical Association (JAMA) found no net benefit from the male hormone testosterone when given for six months to healthy males between the ages of 60 and 80 years with low blood levels of the hormone. Hormones including testosterone have become a focus of interest and promotion as having possible beneficial anti-aging effects.


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Effect of Monotherapy and Combination Therapy with Inhibitors of the Renin–Angiotensin System on Proteinuria in Renal Disease

2008-01-08

Reduction of proteinuria is associated with delayed progression of chronic kidney disease. Reports suggest that angiotensin-receptor blockers (ARBs) reduce proteinuria, but results are variable. The relative effect of ARBs and angiotensin-converting enzyme (ACE) inhibitors, and their combined administration, remains uncertain.

The Purpose of the analysis was to establish the effect of ARBs versus placebo and alternative treatments, and the effect of combined treatment with ARBs and ACE inhibitors, on proteinuria.


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ADDITIONAL SERIOUS SAFETY CONCERNS WITH THE HORMONE REPLACEMENT DRUG TIBOLONE (LIVIAL)

2008-01-08

On September 5, 2007 we published safety information on the drug tibolone (Livial) used for hormone replacement therapy. The basis for this report was the Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update Newsletter. The British authorities were concerned over an increased risk of stroke in older postmenopausal women, those women more than 60 years of age, using tibolone.


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CNS toxicity of Methylthioninium chloride (methylene blue) with serotonergic drugs

2008-01-09

on January 7 , 2008 , the Medicines and Health Care Products Regulatory Agency (MHRA) , the British equivalent to the Saudi Food and Drug Authority (SFDA) , has informed the healthcare professionals that intravenous methylthioninium chloride in high dose should preferably be avoided in patients who have been treated recently with drugs that have serotonergic activity .


Other Awareness Article

CNS toxicity of Methylthioninium chloride (methylene blue) with serotonergic drugs

2008-01-09

on January 7 , 2008 , the Medicines and Health Care Products Regulatory Agency (MHRA) , the British equivalent to the Saudi Food and Drug Authority (SFDA) , has informed the healthcare professionals that intravenous methylthioninium chloride in high dose should preferably be avoided in patients who have been treated recently with drugs that have serotonergic activity .


Other Awareness Article

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