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Healthier diabetics may fare better with less aggressive approach to disease management

Type 2 diabetes drugs could be doing patients more harm than good, especially older diabetics, a new study shows. The research, published in a recent edition of the Journal of the American Medical Association Internal Medicine, addressed how current guidelines for diabetes management were serving patients. Currently, diabetes management involves intensifying treatment until the patient’s blood sugar level has evened out. Researchers say this method appears to cause more negative impacts to patients than positive ones. “For people with type 2 diabetes, the goal of managing blood sugar levels is to prevent associated diabetes complications, such as kidney, eye and ... Read More

Vials of blood thinner Coumadin recalled due to possible contamination

Six lots of the commonly prescribed blood thinner Coumadin (warfarin) are being recalled because visible particulate matter was found in some vials of the drug. If injected, particulate – whether of metallic or non-metallic cellulose matter – can cause serious and potentially fatal adverse reactions including embolization, as well as allergic reactions. Coumadin is a prescription medication used to treat blood clots and to lower the risk of blood clots forming in the body. It is available in both an oral and an injectable formulation. The injectable formulation is typically administered in a hospital setting by health care professionals to ... Read More

Sunshine Labs injectable vitamin supplements recalled

Health care professionals are being advised not to use injectable vitamin drug products distributed by Medical Supply Liquidators LLC with “Sunshine Labs” on the label because the products are not FDA-approved and their safety, effectiveness and quality cannot be assured, the Food and Drug Administration said in a Drug Safety Communication. The vitamins are manufactured by Compound Brothers Dominicana (also known as CB Inc.) in the Dominican Republic. They area sold as prescription injectable nutritional supplements. A Class 1 recall has been initiated on all non-expired products from Compound Brothers Inc. and labeled as Sunshine Labs. Products affected by the ... Read More

Women less likely to tolerate statin side effects

Researchers are suggesting that gender-based therapy would better suit women with diabetes because they are less likely to stick to treatment and have a greater risk of heart disease than men. One reason why diabetic women, in general, fare worse than men with diabetes is because they are less likely to follow through with treatment goals – such a lowering their LDL – or “bad” – cholesterol levels. They are also at greater risk of developing cardiovascular disease related to their diabetes, often because they have a more difficult time lowering their cholesterol. One likely reason why women do not ... Read More

FDA urges patients to get mammograms at MQSA certified facilities

All mammography facilities in the United States are required to meet certain baseline quality standards and be certified to legally operate in the country. The Food and Drug Administration (FDA) enforces this by working with the American College of Radiology (ACR) to conduct routine reviews of sample mammograms. Facilities that are found to be producing substandard products are found in violation of the federal Mammography Quality Standards Act, also known as MQSA. This week, the FDA became aware of problems associated with the quality of mammograms performed at Big Sky Diagnostic Imaging, LLC, located in Butte, Mont. The agency along ... Read More

FDA warns that chemotherapy drug may cause patients to feel drunk

The intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which can cause patients to feel intoxicated, or drunk, during and after treatment, the Food and Drug Administration (FDA) warned in a safety communication. The agency is ordering all docetaxel drug products to add a warning to their safety labels regarding this possible side effect. Docetaxel is a prescription chemotherapy drug used to treat various types of cancer including breast, prostate, stomach, head and neck, and non-small-cell lung cancers. It is known by the brand names Taxotere and Docefrez. Known as a taxane, the drug works by interfering with microtubules, ... Read More

FDA warns of serious, life-threatening allergic reactions with OTC acne products

Rare but serious and potentially life threatening allergic reactions or severe irritation have been reported by consumers who used certain over-the-counter (OTC) topical acne products, the Food and Drug Administration (FDA) warned. People are advised to stop using the acne products and seek emergency medical attention immediately if they experience any symptoms of hypersensitivity, which include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips or tongue. People should also stop using the products if they develop hives or itching. These hypersensitivity reactions can occur within minutes to a day or more after using these products. ... Read More

Injuries, death linked to recalled NaturaLyte dialysis concentrate

Fresenius Medical Care, the world’s largest provider of dialysis products and services, has received one report of death and two injuries linked to recalled lots of NaturaLyte liquid bicarbonate concentrate. The recall was initiated after testing revealed that certain lots of NaturaLyte had elevated levels of a bacteria identified as Halmonas, a Gram Negative bacteria typically found in water with high salinity. Bacterial contamination of dialysate could cause bacteremia or systemic infection. Fresenius issued a recall of 49 lots in on April 4, followed by a second recall of nine additional lots on May 1. At that time, Fresenius said that ... Read More

Fecal management systems recalled due to serious injuries, death

A recall of all ConvaTec Flexi-Seal CONTROL Fecal Management System Kits has been issued following 12 reports of serious injuries and one death at U.S. health care facilities related to the products. The adverse events were reported from February 2013 through March 2014. The device is not approved by the Food and Drug Administration (FDA) and no application has ever been submitted to the agency for review. The Fecal Management System Kits are used in health care facilities to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by ... Read More

FDA approves first-ever nasal testosterone spray

The Food and Drug Administration (FDA) has given clearance for the first-ever nasal testosterone replacement treatment. Natesto Nasal Gel, manufactured by Trimel Pharmaceuticals, is intended for adult males with conditions associated with deficiency or absence of endogenous testosterone, including primary hypogonadism or hypogondotropic hypogondism. Low testosterone levels are associated with symptoms such as low libido, muscle loss, fatigue and weight gain. Natesto is self-administered into the nostrils via a metered-dose pump applicator, which delivers 5.5 mg of testosterone. The recommended dosage is 11 mg, or two pumps (one in each nostril), three times daily. The nasal spray offers a new ... Read More