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Warning Date
    2009-02-25

Innohep and the Risk of Death in Elderly Renal Insufficiency Patients

2009-02-25

Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-03-18

FDA Warns About Risk of Wearing Medicated Patches During MRIs

2009-03-18

Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-04-08

FDA Expands Warning to Consumers About Tainted Weight Loss Pills

2009-04-08

FDA expanded its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes 72 products.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-04-08

Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use

2009-04-08

The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-04-22

FDA notified healthcare professionals about Ceftriaxone (update)

2009-04-22

FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion lines.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-05-09

FDA Warning against using Hydroxycut products

2009-05-09

The U.S. Food and Drug Administration the equivalents to the Saudi Food and Drug Authority (SFDA) is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-06-17

updated information about the leukotriene inhibitors

2009-06-17

FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communication about the ongoing safety review for the leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-07-08

Ceftriaxone (marketed as Rocephin and generics)

2009-07-08

FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion lines.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-07-20

Information for Healthcare Professionals: Varenicline and Bupropion

2009-07-20

The U.S. Food and Drug Administration, the American counterpart to the Saudi Food and Drug Authority (SFDA), has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2009-07-29

FDA Warns Consumers Not to Use Body Building Products Marketed as Containing Steroids or Steroid-Like Substances

2009-07-29

FDA notified both healthcare professionals and their patients about new safety information concerning products marketed for body building and increasing muscle mass, frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and sold both online and in retail stores. These products are promoted to athletes to improve sports performance and to aid in recovery from training and sporting events.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

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