Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Cases of acute renal failure, some with a fatal outcome, have been reported following the post marketing use of Exjade. Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States. Both products -- touted as sexual enhancement products and as treatments for erectile dysfunction (ED) -- are illegal drug products that contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.

Consumers are urged not to buy or use four health products and two proprietary Chinese medicines that contain potentially hazardous ingredients which can cause side effects, the Department of Health says.

The health products are Power 58 Extra, Platinum Power 58 Extra, E nhanix New Extra Men's Formula and Valentino. The two proprietary Chinese medicines are King Power Oral Solution and Stretch Up Capsules.

 Power 58 Extra

FDA warned consumers to avoid using tubes of toothpaste labeled as "Made in China". The warning and an import alert were issued to prevent toothpaste containing a poisonous chemical, diethylene glycol (DEG) from entering the United States from China. The substance is used in antifreeze and as a solvent. Although FDA is not aware of any U.S. reports of poisonings from toothpaste containing DEG, FDA is concerned about chronic exposure to DEG and exposure to the product in certain populations, such as children and individuals with kidney or liver disease.

OTTAWA - Health Canada is warning consumers not to use the product Encore Tabs for Men, because it contains an undeclared pharmaceutical ingredient similar to the approved drug tadalafil. Tadalafil is a prescription medication indicated for the treatment of erectile dysfunction and should only be used under the supervision of a health professional.

FDA notified healthcare professionals and cystic fibrosis patients in U.S that the Agency is investigating the possible connection between the use of a liquid solution of Colistimethate that was premixed for inhalation with a nebulizer and the death of a patient with cystic fibrosis (CF).

Roche and FDA informed healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of the prescribing information for Rocephin for Injection. The revisions are based on new information that describes the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported.

Selenium supplementation may raise the risk for type 2 diabetes, reports a study published early online in the Annals of Internal Medicine.

In an analysis from the Nutritional Cancer Prevention study, researchers sought to determine whether selenium supplementation would lower the risk for type 2 diabetes. Some 1200 adults were randomized to receive 200 micrograms of the supplement or placebo daily. Nearly all participants were white.

Health Canada is advising consumers not to use the sleep supplement product Optimum Health Care Sleep Easy, because it contains the undeclared drug clonazepam, which can be habit forming when used for as little as a few months. Consumers who may still have this product in their homes are advised to consult with a health care professional before they stop taking the pills, because of the risk of serious withdrawal symptoms.

Health Canada is warning Canadians not to use Neem Active Toothpaste with Calcium, manufactured by Calcutta Chemical Co. Ltd. in India and found on the Canadian market, because it has been found to contain unacceptable levels of diethylene glycol (DEG).