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Weekly Drug News Round Up - January 22, 2014

FDA: Certain Wart Removers Are a Fire Hazard

Singed hair, blisters, burns or skin redness, have occurred, in addition to home items catching on fire Read More...

Over the last five years, the U.S. Food and Drug Administration -- which regulates wart removers as medical devices -- has received 14 reports of home fires caused by over-the-counter, cryogenic wart remover products. These wart remover products, which are a mixture of liquid dimethyl ether and propane, are highly flammable; this is stated on their labeling. Information clearly states these products should be kept away from fire, flame, heat sources, and cigarettes, but consumers may not realize everyday household items like curling irons and straight irons may generate enough heat to cause ignition, as well. Consumers can report device-related problems through FDA's MedWatch alert system.

FDA Cracks Down on Internet Pharmacy Fraud

Rogue pharmacies sell fraudulent medications that come from Southeast Asia, the Middle East, North Africa and South and Central America Read More...

The U.S. Food and Drug Administration (FDA) is warning consumers not to order medicines from web sites that claim to be Canadian pharmacies. The FDA states that most of these pharmacies are not legitimate, and the drugs they supply are illegal and potentially dangerous. Some of the illegal sites used the names of well-known pharmacies to trick consumers into believing that there was an affiliation with those stores. Examples include www.walgreens-store.com and www.c-v-s-pharmacy.com. The banner of the FDA’s Cybercrime Investigations Unit is now displayed on seized pharmacy Internet sites to mark them as illegal.

New JAMA Studies Evaluate FDA Approval Process

The American public relies on FDA to complete a balanced, unbiased review of drugs and medical devices prior to approval Read More...

Three studies published in the Journal of the American Medical Association (JAMA) reveal that the U.S. Food and Drug Administration (FDA) could be more transparent to the public and healthcare providers about the level of data evaluated when new drugs are approved. Also, a study found most implantable cardiac devices used today - items like pacemakers and defibrillators - were okayed as changes to already-approved models and did not require collection of new clinical data. Finally, FDA conducted its own study to look at why new medication approvals were delayed or denied from 2000 to 2012. Problems with correct dosages, study groups, or valid study endpoints were cited as problems.

Vitamin D: The “Sunshine Vitamin” May Benefit Multiple Sclerosis Patients

In addition to supplements, Vitamin D is obtained from sunlight and foods such as fatty fish and fortified dairy products Read More...

A new report in JAMA Neurology suggests that vitamin D may slow the progression of multiple sclerosis (MS) and also reduce harmful brain activity. In the research, vitamin D levels were measured in 465 patients with signs of MS. During the first year of follow-up, increases in vitamin D were associated with a 57 percent lower risk in both the development of new brain lesions and also of disease relapse. Subjects also had a 25 percent lower yearly increase in brain lesion size. However, some experts express doubt, stating randomized controlled trials are needed and that vitamin D doses are not well defined for MS.

Immunotherapy May Add Months to Survival in Pancreatic Cancer

These vaccines enhance the immune system and 'train' it to recognize and attack pancreatic cancer cells Read More…

In a new study scheduled for presentation this week at the American Society of Clinical Oncology meeting in San Francisco, researchers randomly assigned 90 patients with advanced pancreatic cancer to Aduro BioTech’s GVAX vaccine followed by CRS-207 or GVAX alone. The investigators found that patients who received both vaccines lived 6.1 months, compared with 3.9 months for those who received only GVAX. Patients who received additional doses of GVAX survived an average of 9.7 months compared with 4.6 months for those who received GVAX alone. The most common side effects, reported as mild, were fever and chills. In addition, this week researchers reported on a blood test under study to diagnose pancreatic cancer.

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