New warnings added to prescribing information for cancer drug
ROCKVILLE, Md. The Food and Drug Administration last week posted a notification to healthcare professionals around the safety profile of the cancer drug Tarceva to its MedWatch Web site.
Adverse events associated with the drug include gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva.
The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports, the FDA stated.
FDA grants clearance of market, sale of new allergy-friendly latex condom
WILMINGTON, Del. Vystar and Alatech Healthcare on Friday announced that the Food and Drug Administration granted 510(k) clearance to market and sell Alatech’s Envy condom manufactured with Vytex Natural Rubber Latex.
The Envy condom will be the first consumer medical product available in the U.S. made from Vystar’s patented Vytex NRL, which has less than 2 micrograms/dm2, virtually undetectable levels, of the antigenic proteins that can cause an allergic response, while retaining and improving upon all the desirable qualities of latex.
The Envy condom will carry labeling that will reflect the lowest antigenic protein content currently available in a natural rubber latex medical device in the U.S. Natural rubber latex contains more than 200 proteins, similar to other natural plant materials, of which 13 are known allergens. The Vytex NRL process was created to significantly reduce these known proteins. Vystar’s business model is to assist all manufacturers in marketing the Vytex component of their products.
Alatech will market and sell the Envy NRL condom to retailers and through other distribution channels, and expects the product to be available to consumers in the coming months.
Food intake may contribute more to obesity than lack of exercise, study suggests
AMSTERDAM Conventional wisdom has it that the American obesity epidemic results from lack of exercise, but a study presented in the Netherlands Friday suggests otherwise.
The study, led by researchers in Australia and presented at the 17th European Congress on Obesity in Amsterdam, indicates that while exercise remains important, the main cause of the obesity epidemic is that Americans eat too much.
“To return to the average weights of the 1970s, we would need to reverse the increased food intake of about 350 calories a day for children and 500 calories a day for adults,” lead study author Boyd Swinburn of Australia’s Deakin University said in a statement. That would mean eliminating a can of soda or small portion of French fries from a child’s diet or a large hamburger from an adult’s.
The researchers started by testing 1,399 adults and 963 children to find how many calories they burn on an average day. They combined those results with national food supply data on how much food Americans ate between the 1970s and early 2000s. They then calculated how much weight they would expect Americans to have gained in the 30-year period if food intake were the sole influence, using national survey data that recorded the weight of Americans during that period.
“For adults, we predicted that they would be 10.8 kg heavier, but in fact they were 8.6 kg heavier,” Swinburn said. “That suggests that excess food intake still explains the weight gain, but that they may have been increases in physical activity over the 30 years that have blunted what would otherwise have been a higher weight gain.”
According to the Centers for Disease Control and Prevention, more than 30% of American adults are obese, which health experts define as having a body mass index of 30 or greater.