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Monthly Archives: April 2012

Potential Signals of Serious Risks/New Safety Information Identified by AERS, October to December 2011 –


Product Name: Active Ingredient   (Trade) or Product Class Potential Signal of a Serious   Risk/New Safety Information Additional Information (as of   February 15, 2012)*
Bortezomib (Velcade, Takeda) Death from intrathecal   administration (medication error) The Dosage and Administration and   Contraindications sections of the labeling for bortezomib were updated   January 2012 to include fatal events with intrathecal administration.
Brentuximab   vedotin (Adcetris,   Seattle Genetics) Progressive multifocal   leukoencephalopathy (PML) The Boxed Warning and Warnings and   Precautions sections of the labeling for brentuximab were updated January   2012 to include PML.
Fluoroquinolone products Peripheral sensorimotor neuropathy FDA is continuing to evaluate this   issue to determine whether the current labeling, which contains information   about peripheral sensorimotor neuropathy, is adequate.
Gabapentin HCl (Neurontin, Pfizer) Increase in blood creatine   phosphokinase levels and rhabdomyolysis
Gadolinium-based   contrast agents products Acute kidney injury FDA is continuing to evaluate this   issue to determine whether the current labeling, which contains information   about kidney injury, is adequate.
Iloprost inhalation solution (Ventavis, Actelion   Pharmaceuticals) Hemoptysis
Loperamide HCl–containing products   (Imodium,   McNeal Consumer Healthcare) Pancreatitis
Magnesium sulfate for injection Fetal skeletal demineralization,   hypermagnesemia, and other bone abnormalities with continuous long-term use   in pregnant women
Milnacipran HCl (Savella, Forest   Pharmaceuticals) Homicidal ideation
Pegloticase (Krystexxa, Savient   Pharmaceuticals) Anaphylaxis and infusion reactions
Phenytoin (Dilantin, Pfizer) and   nondepolarizing neuromuscular blocking agents Drug interactions resulting in   decreased effectiveness of the nondepolarizing neuromuscular blocking agent
Polyethylene glycol 3350   over-the-counter oral laxative (Miralax,   MSD Consumer Care) Neuropsychiatric events FDA decided that no action is   necessary at this time on the basis of available information.
Proton-pump   inhibitor over-the-counter (OTC) products Clostridium difficile-associated   diarrhea
Rubidium Rb82   generator(CardioGen-82,   Bracco Diagnostics) Unintended radiation exposure to   strontium isotopes after myocardial imaging Rubidium Rb82 generator was voluntarily   recalled by the manufacturer in July 2011; a return to the   US market is planned. The Boxed Warning, Dosage and   Administration, and Warnings and Precautions sections of the labeling for   rubidium Rb82 generator were updated February 2012 to include information   about unintended radiation exposure.
Sorafenib tosylate (Nexavar, Onyx   Pharmaceuticals) Osteonecrosis of the jaw
Telaprevir (Incivek, Vertex   Pharmaceuticals) Serious skin reactions, including   drug reaction with eosinophilia and systemic symptoms (DRESS) and   Stevens-Johnson syndrome (SJS)

*Unless otherwise noted, the FDA is continuing to evaluate these issues to determine the need for any regulatory action.


World Malaria Day –  April 25, 2012

On World Malaria Day, we stand at a critical juncture in our efforts to control a global scourge. This year’s theme—Sustain Gains, Save Lives: Invest in Malaria—stresses the crucial role of continued investment of resources to maintain hard-won gains. Lives have indeed been saved. According to World Health Organization (WHO) estimates, annual deaths from malaria decreased from roughly 985,000 in 2000 to approximately 655,000 in 2010. Improvements were noted in all regions that WHO monitors, and, since 2007, four formerly malaria-endemic countries—the United Arab Emirates, Morocco, Turkmenistan and Armenia—have been declared malaria-free. However, about half of the world’s population is at risk of contracting malaria, and the disease continues to exact an unacceptably high toll, especially among very young children and pregnant women.

While it is paradoxical that poverty and obesity exist hand in hand, so too is the reality that the obese poor tend to be under- or mal-nourished. How can this be?
This is because the poor eat the poorest food.

Perhaps part of our problem is that when we see those trapped in the cycle of poverty, we look and say “Oh, she’s fat, she must have enough to eat.” This is not just a huge misunderstanding of the reality which faces the majority of our people every day, it is a malicious misrepresentation.

Poorly nourished infants have been found to be predisposed to obesity in later life. This occurs by interference with the genetic programming of the body, mainly in utero. If a mother does not receive adequate nutrition, the lot of her baby can become forever compromised. This is how the tragedy of poverty is perpetuated, inter-generationally. This occurs directly through malnutrition, as well as through other rather more sinister mechanisms.

One of the first consequences is that industrially grown food is, from the outset lower in minerals, vitamins and other important nutrients like flavinoids, than food grown in rich, healthy soils. The nutrient value of our food has dropped consistently over the past half-century.

Secondly, most industrial foods carry residual levels of these chemicals and pesticides, many which are known endocrine disruptors. Endocrine or hormone disruptors are closely associated with serious negative health impacts, including obesity, diabetes and hypertension. This chemical exposure is known as our body burden.

So here we effectively have a double whammy. The poor eat food which predisposes them to poor health, on top of another, existing predisposition, genetically caused by malnutrition in the uterus or as infants.

Consequently, the cheapest staple foods lack all but the most basic nutritional requirements. Most food contains only refined carbohydrates and chemically stripped oils. The vetkoek diet. So the poor consume white flour, maize meal, polished rice, highly processed vegetable oils, with no real nutritional value. This empty food does no more than fill the stomach – it has calories but no nutrients, a recipe for obesity.

If protein is consumed it is usually cheap, processed soya, which is not readily digested and which contains several anti-nutrients that in turn block absorption of important minerals like iron, calcium and zinc. If meat is consumed it too is cheap and nasty – polony, battery chicken and feedlot livestock with its high levels of bad omega 3 fats, increasing hypertension risks.

To compound these corporeal insults, high levels of toxic preservatives like nitrates and nitrites, both known carcinogens, or preservatives like sulphur dioxide – linked to respiratory problems are added to industrial foods. Taste enhancers are added to dilute the blandness; chemicals like monosodium glutamate, aspartame and other artificial flavourants and colourants each add insult to injury. And don’t forget the sugar, which many want to classify as a toxin.

By decentralising our food supply and encouraging the growth of market gardens, of communal food gardens, of vegetable plots on schools, in backyards, along the verges of our suburbs, in every available space in our cities, we can easily break this cycle. Why on earth do we plant decorative plants in the midst of such need when we can plant food? Why plant decorative trees when we can plant fruit trees? What is to stop our huge numbers of unemployed, malnourished citizens from being assisted to grow their own food? Huge opportunities exist to break this self-perpetuating scourge which is ruining the life of our people.

Another interesting trigger for obesity is stress. Stress is closely related to poverty in that high stress levels are caused directly through overcrowding, noise, crime and of course financial stress.

Results from two studies reveal that a daily antiretroviral tablet taken by people who do not have HIV infection can reduce their risk of acquiring HIV by up to 73%. Both daily tenofovir and daily tenofovir/emtricitabine taken as preventive medicine (PrEP – pre-exposure prophylaxis) can prevent heterosexual transmission of HIV from men to women and from women to men.

There were 62% fewer HIV infections in the group receiving tenofovir and 73% fewer HIV infections in the group that took tenofovir /emtricitabine than in the group receiving the placebo.


Prebiotics and probiotics can restore the balance of bacteria in your digestive tract. Probiotics are beneficial bacteria that can be found in various foods. When you eat probiotics, you will add these healthy bacteria to your intestinal tract. Common strains include Lactobacillis and Bifidobacterium families of bacteria.

Prebiotics are non-digestible foods that make their way through our digestive system and help good bacteria grow and flourish. Prebiotics keep beneficial bacteria healthy.

Prebiotics in the Diet:

Prebiotics that feed the beneficial bacteria in your gut mostly come from carbohydrate fibers called oligosaccharides. You don’t digest them, so the oligosaccharides remain in the digestive tract and stimulate the growth of beneficial bacteria. Sources of oligosaccharides include fruits, legumes, and whole grains. Fructo-oligosaccharides may be taken as a supplement or added to foods. Yogurt made with bifidobacteria contain oligosaccharides.

Probiotics in the Diet:

Probiotic bacteria like lactobacilli are naturally found in fermented foods like sauerkraut and yogurt. Some foods will have added probiotics as healthy nutritional ingredients, which will be evident on the label.

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