The longer a person took low–dose aspirin, the lower his or her risk for developing pancreatic cancer, according to a study published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research. “We found that the use of low–dose aspirin was associated with cutting the risk of pancreatic cancer in half, with some evidence that the longer low–dose aspirin was used, the lower the risk,” said Harvey A. Risch, MD, PhD, professor of epidemiology in the Department of Chronic Disease Epidemiology at the Yale School of Public Health and Yale Cancer Center in New Haven, Connecticut.
“Because about one in 60 adults will get pancreatic cancer and the five–year survival rate is less than 5 percent, it is crucial to find ways to prevent this disease.” Men and women who took low–dose aspirin regularly had 48 percent reduction in their risk for developing pancreatic cancer. Protection against pancreatic cancer ranged from 39 percent reduction in risk for those who took low–dose aspirin for six years or less, to 60 percent reduction in risk for those who took low–dose aspirin for more than 10 years.
Taken from American Association for Cancer Research News
The U.S. Food and Drug Administration approved Afrezza (insulin human) Inhalation Powder, a rapid–acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid–acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.
"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean–Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.”
The drug’s safety and effectiveness were evaluated in a total of 3,017 participants–1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes. The efficacy of mealtime Afrezza in adult patients with type 1 diabetes patients was compared to mealtime insulin aspart, both in combination with basal insulin in a 24 week study. At week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA1c that met the pre–specified non–inferiority margin of 0.4 percent. Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant.
Afrezza was studied in adults with type 2 diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24 week study. At week 24, treatment with Afrezza plus oral antidiabetic drugs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group. Afrezza is not a substitute for long–acting insulin. Afrezza must be used in combination with long–acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke. Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and COPD.
Taken from FDA Press Announcements
FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning
The U.S. Food and Drug Administration (FDA) warns that prescription oral viscous lidocaine 2 percent solution should not be used to treat infants and children with teething pain. We are requiring a new Boxed Warning, FDA’s strongest warning, to be added to the drug label to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death. Health care professionals should not prescribe or recommend this product for teething pain.
Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain:
1) Use a teething ring chilled in the refrigerator (not frozen)
2) Gently rub or massage the child’s gums with your finger to relieve the symptoms.
Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.
Taken from FDA What's New: Drugs
FDA Drug Safety Communication: FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products
The U.S. Food and Drug Administration (FDA) is warning that certain over–the–counter (OTC) topical acne products can cause rare but serious and potentially life–threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching.
These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels. Based on the information reported to FDA, we cannot determine if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both. The hypersensitivity reactions may occur within minutes to a day or longer after product use. The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear.
Taken from FDA What's New: Drugs
In an international, retrospective study the effectiveness of the controversial neuraminidase inhibitor Tamiflu (active ingredient Oseltamivir) has been proven. The paper, recently published in “The Lancet Respiratory Medicine”, which drew data from over 29,000 hospital patients who tested positive for H1N1 influenza, proved via 78 centres in 40 countries, including the MedUni Vienna with the University Department of Internal Medicine I (Clinical Department of Infectious Diseases and Tropical Medicine), that taking neuraminidase inhibitors reduces mortality among those affected by 20 per cent – regardless of when they took the medication.
“If neuraminidase inhibitors were given in the first two days of the illness, mortality was actually reduced by 50 per cent,” says Heinz Burgmann from the Clinical Department of Infectious Diseases and Tropical Medicine at the MedUni Vienna, summarising the findings. “This effect only occurs in adults, however.” And only for H1N1 influenza – not for a "normal" influenza infection. This means that the international scientists, led by the Division of Epidemiology and Public Health at the University of Nottingham, were also able to contradict a meta–analysis by the Cochrane Collaboration which had attributed a very weak effect to Tamiflu.
Taken from Medical University of Vienna
BPA stimulates growth of an advanced subtype of human breast cancer cells called inflammatory breast cancer
Environmental exposure to the industrial chemical bisphenol A (BPA) lowers the effectiveness of a targeted anti–cancer drug for inflammatory breast cancer, according to a new study that was performed in human cancer cells. The results, which were presented at the ICE/ENDO 2014, also show that BPA causes breast cancer cells to grow faster.
"Routine exposures to common environmental chemicals like BPA appear to contribute to breast cancer cell progression and to diminish drug treatment efficacy, particularly in inflammatory breast cancer," said principal investigator Gayathri Devi, PhD, associate professor, Department of Surgery, Duke University Medical Center, Durham, N.C. In addition, this study reported that BPA lowered the effectiveness of an approved cancer–fighting drug, lapatinib, used in breast cancer therapy. Other FDA approved anti–cancer drugs are currently being tested by this team. Devi said the results may have immediate implications in cancer treatment.
Taken from Science Daily
FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots as a possible consequence of polycythemia is already included in the labeling of testosterone products. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots, to ensure this risk is described consistently in the labeling of all approved testosterone products.
This new warning, a class labeling change, is not related to an ongoing FDA evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. FDA is currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in a January 31, 2014 MedWatch Safety Alert.
Taken from FDA
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