Category: Clinical News

Cease all the Unadulterated Fish

Clinical News, Industry News, OMG, Social Awareness

At the request of the U.S. Food and Drug Administration, a judge has ordered L.A. Star Seafood Company Inc., located in Los Angeles, and its owners, Sima and Sam Goldring, to halt operations until they demonstrate to the FDA that they can process food in compliance with food safety laws and regulations.

In 2012, at the FDA’s request, the company recalled some of its products due to potential contamination. In 2013, the FDA inspected the L.A. Star facility, and sent the company a warning letter detailing steps the company must take to comply with the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice requirements. In 2014, another inspection of the L.A. Star facility documented the company and its owners’ continued failure to comply with the law.

“The FDA takes legal action to protect the public’s health when it is necessary,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “This consent decree represents an agreement between the FDA and L.A. Star to ensure that if and when they reopen for business, they will be producing food that meets food safety requirements.”

The consent decree of permanent injunction requires L.A. Star to control for the presence of Listeria monocytogenes (L. mono) and Clostridium botulinum (C. bot), two disease-causing bacteria. The consent decree also requires the company to devise and implement Hazard Analysis Critical Control Point plans and Sanitation Standard Operating Procedures, and train staff in both.

L. mono is a foodborne pathogen that can cause serious illness or even death in vulnerable groups such as newborns, elderly adults and those with impaired immune systems. C. bot, a bacterium that can grow in seafood products, causes botulism, which is rare, but can cause paralysis and death without prompt treatment. The purpose of food safety regulations is, in part, to prevent the growth and spread of L. mono, C. bot and other microorganisms that cause foodborne illness.

No illnesses have been reported to date in connection with L.A. Star Seafood Company, Inc. products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Two therapies to treat IBS-D

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The U.S FDA today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

According to the National Institutes of Health, patients with irritable bowel syndrome (IBS) experience a number of signs and symptoms, including pain or discomfort in the abdomen and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States. IBS-D is a subtype characterized mainly by loose or watery stools at least 25 percent of the time.

“For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “The approval of two new therapies underscores the FDA’s commitment to providing additional treatment options for IBS patients and their doctors.”

Viberzi, which contains a new active ingredient, is taken orally twice daily with food. Viberzi activates receptors in the nervous system that can lessen bowel contractions. Viberzi is intended to treat adults with IBS-D.

Xifaxan can be taken orally three times a day for 14 days, for the treatment of abdominal pain and diarrhea in patients with IBS-D. Patients who experience a recurrence of symptoms can be retreated with a 14 day treatment course, up to two times. Xifaxan, an antibiotic derived from rifampin, was previously approved as treatment for travelers’ diarrhea caused by E. coli and for reduction of the risk in adult patients of recurring overt hepatic encephalopathy, the changes in brain function that occur when the liver is unable to remove toxins from the blood. The exact mechanism of action of Xifaxan for treatment of IBS-D is not known, but is thought to be related to changes in the bacterial content in the gastrointestinal tract.

The safety and effectiveness of Viberzi for treatment of IBS-D were established in two double-blind, placebo-controlled clinical trials in which 2,425 patients were randomly assigned to receive Viberzi or placebo. Results showed Viberzi was more effective in simultaneously reducing abdominal pain and improving stool consistency than placebo over 26 weeks of treatment.

The safety and effectiveness of Xifaxan for treatment of IBS-D were established in three double-blind, placebo-controlled trials. In the first two trials, 1,258 patients were randomly assigned to receive Xifaxan or placebo for 14 days, and then followed for a 10-week treatment-free period. More Xifaxan-treated patients reported improvements in abdominal pain and stool consistency than those on placebo. A third trial evaluated repeat courses of Xifaxan, because patients with IBS-D can develop recurrent signs and symptoms after a single treatment course of Xifaxan. A total of 636 patients with recurrence were randomized to receive either Xifaxan or placebo for two additional 14-day courses separated by 10 weeks. More patients treated with Xifaxan than placebo were responders in abdominal pain and stool consistency in this phase of the study.

The most common side effects in patients treated with Viberzi include constipation, nausea and abdominal pain. The most serious known risk associated with Viberzi is the risk of spasm in the sphincter of Oddi, the smooth muscle that surrounds the end portion of the common bile and pancreatic ducts, which can result in pancreatitis. Viberzi should not be used in patients with a history of bile duct obstruction, pancreatitis, severe liver impairment, or severe constipation, and in patients who drink more than three alcoholic beverages per day.

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New, non-surgical temporary balloon to treat obesity

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The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach.

The device does not change or alter the stomach’s natural anatomy. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

 

The ReShape Dual Balloon was studied in a clinical trial with 326 obese participants aged 22 to 60 (with a BMI of 30 kg/m2 to 40 kg/m2) who had at least one obesity-related health condition. In the study, 187 individuals randomly selected to receive the ReShape Dual Balloon lost 14.3 pounds on average (6.8 percent of their total body weight) when the device was removed at six months, while the control group (who underwent an endoscopic procedure but were not given the device) lost an average of 7.2 pounds (3.3 percent of their total body weight).

Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9.9 pounds of the 14.3 pounds they lost.

Potential side effects for the procedure include headache, muscle pain, and nausea from the sedation and procedure; in rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.

 

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Modernizing the Food Safety System.

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The U.S. Food and Drug Administration (FDA) today took one of the most significant steps in decades to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).

Today’s action is the first step in putting greater emphasis on the prevention of foodborne illness, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities.

An estimated 48 million people (1 in 6 Americans) get sick each year from foodborne diseases, according to recent data from the U.S. Centers for Disease Control and Prevention. Approximately 128,000 are hospitalized, and 3,000 die each year. Over the past few years, high-profile outbreaks related to various foods, from spinach to peanut products, have underscored the need to make continuous improvements in food safety.

“Today’s announcement sets us on the path to a modern food safety system that will prevent illnesses and continue to build confidence in the safety of the food served to our families every day,” said Dr. Stephen Ostroff, acting FDA commissioner.

The two rules finalized today, the preventive controls rules, focus on implementing modern food manufacturing processes for both human and animal foods.  Today’s announcement will ensure that food companies are taking action and working with the FDA to prevent hazards to customers on the front end, rather than waiting to act until an outbreak has occurred.

The preventive controls rules require human and animal food facilities to develop and implement written food safety plans that indicate the possible problems that could affect the safety of their products and outline steps the facility would take to prevent or significantly minimize the likelihood of those problems occurring. This means that food companies will be accountable for monitoring their facilities and identifying any potential hazards in their products and prevent those hazards.  Under these rules, the FDA will be able to assess these systems and their outcomes to prevent problems, will better be able to respond when food safety problems occur, and better protect the safety of manufactured food.

The preventive controls final rules announced today are the result of an extensive outreach effort, and incorporate thousands of public comments, including valuable input from farmers, consumers, the food industry and academic experts, to create a flexible and targeted approach to ensuring food safety.

“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA. “And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first.”

Once the seven FSMA rules are finalized in 2016, they will work together to systematically strengthen the food safety system and better protect public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

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New Drug for treatment of Diabetes

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he U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

 

“Long-acting insulins play an essential role in the treatment of patients with type-1 diabetes and in patients with type-2 diabetes with advanced disease,” 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. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”

Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Dosing of Tresiba should be individualized based on the patient’s needs. Tresiba is administered subcutaneously once daily at any time of day.

The efficacy and safety of Tresiba used in combination with mealtime insulin for the treatment of patients with type-1 diabetes were evaluated in two 26-week and one 52-week active-controlled clinical trials involving 1,102 participants exposed to Tresiba. The efficacy and safety of Tresiba used in combination with mealtime insulin or used as add-on to common background oral antidiabetic drugs for the treatment of patients with type-2 diabetes were evaluated in four 26-week and two 52-week active-controlled clinical trials involving 2,702 participants exposed to Tresiba. In participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Tresiba provided reductions in HbA1c (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control) in line with reductions achieved with other, previously approved long-acting insulin.

Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. 

The efficacy and safety of Ryzodeg 70/30 used in combination with mealtime insulin for the treatment of patients with type 1 diabetes were evaluated in one 26-week active controlled clinical trial involving 362 participants exposed to Ryzodeg 70/30. The efficacy and safety of Ryzodeg 70/30 administered once or twice daily for the treatment of patients with type 2 diabetes were evaluated in four active controlled 26-week clinical trials involving 998 participants exposed to Ryzodeg 70/30. In participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Ryzodeg 70/30 provided reductions in HbA1c equivalent to reductions achieved with other, previously approved long-acting or pre-mixed insulin.

Tresiba and Ryzodeg should not be used in those who have increased ketones in their blood or urine (diabetic ketoacidosis). Patients or caregivers should monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Tresiba and Ryzodeg may cause low blood sugar (hypoglycemia), which can be life-threatening. Patients should be monitored more closely with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment orhypoglycemia unawareness.

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin.

The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.

Tresiba and Ryzodeg are manufactured by Novo Nordisk in Plainsboro, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Can Technology replace Doctors?

Clinical News, Industry News, OMG, Research, Social Awareness

It’s true.

Health care technology is transforming at record speeds, almost at pace with Apple’s release of a new iPhone. A digitally globalized world means more power than ever is in the hands of the patient.

Around one in 10 Americans wear some form of technology on a daily basis, whether it’s a smart–phone or a device to track medical information. It may sound like the premise of a science fiction film, but Mark Benden, C.P.E., Ph.D., associate professor at the Texas A&M Health Science Center School of Public Health, director of the Texas A&M Ergonomics Center and member of the Center for Remote Healthcare Technologies and Systems, believes wearable technology is rapidly approaching the point where devices become omniscient about a patient’s needs and personal habits. “We see wearable devices on a daily basis.

The most common devices – like the Fitbit – are built–in mechanisms that communicate with your cell phone. Soon, we will have devices in all environments – they will monitor us in our homes, while we’re at work and during our personal lives.

As these different devices ‘talk’ to each other, they will be able to know people’s habits and practices. Essentially, they will coach and motivate patients,” Benden said.

And in health care, this type of scientific advancement is powerful. With more than 140 million Americans living with at least one chronic medical condition, these devices could keep patients out of the hospital and monitored on a routine basis.

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