U.S. FDA Warns of Dangers of Liquid Nitrogen in Food, Drinks

You risk serious injury if you consume or handle food and drink products where liquid nitrogen is added just before consumption, the U.S. Food and Drug Administration warned Friday.

These products — which have names such as “Dragon’s Breath,” “Heaven’s Breath” and “nitro puff” — are available in food courts, kiosks, state or local fairs, and other places where food and drinks are sold.

Examples of such products include liquid nitrogen-infused colorful cereal or cheese puffs that emit a misty or smoke-like vapor, and alcoholic and nonalcoholic drinks prepared with liquid nitrogen that emit a fog.

Liquid nitrogen isn’t toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release. Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma, according to the agency.

“The main issue is that liquid nitrogen must be fully evaporated from food or beverage before it is served,” explained Dr. Robert Glatter, an emergency room physician at Lenox Hill Hospital in New York City.

“In liquid form, it can cause burns to the mouth, esophagus and upper airway, leading to perforation or rupture of the organs — which could be deadly,” Glatter said. “It may also cause burns of the fingers or hands when it is handled in the liquid state.”

And people with asthma or lung disease who inhale the vapors might experience constriction of their airways, triggering an asthma attack or worsening of their lung disease, he added.

“Beyond this, it may also lead to inflammation in the lungs and aspiration, which can reduce the ability to breathe, as well as trigger infections such as pneumonia,” Glatter said.

In fact, the FDA said it has received reports of severe and life-threatening injuries caused by liquid nitrogen in food and drinks, and also reports of breathing problems.

“With state fairs upon us, parents and teens need to understand the potential risks of foods such as nitro popcorn and nitrogen-infused cereals, which promise excitement and thrill but may end with a trip to the emergency department,” Glatter noted.

People who’ve suffered an injury after handling or consuming food or drinks prepared with liquid nitrogen should consult a health care provider, and also consider reporting their injury to MedWatch, the FDA’s safety reporting program, the agency said.

Source: HealthDay

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U.S. Food and Drug Administration Warns Vaginal Rejuvenation Devices have Serious Side Effects

From press release of FDA . . . . . .

We’ve recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.

As part of our efforts to promote women’s health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts). But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for “vaginal rejuvenation.” In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.

In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.

We haven’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.

Today, we’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared.

We recently notified seven device manufacturers of our concerns about inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. We requested that the manufacturers address our concerns within 30 days. If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate. This matter has the full attention of our professional staff.

The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions. These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options. Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.

We’ve been focused on advancing new policies to improve our oversight of device safety. As part of our Medical Device Safety Action Plan and our ongoing commitment to advancing women’s health, we’ve begun building out important device safety registries. We’ve also established the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.

As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with “vaginal rejuvenation” procedures. We will keep the public informed if significant new information becomes available. We’d also like to learn more about patients’ experiences with these procedures. We encourage those who’ve had an adverse event associated with the use of these devices to report their problem to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Source: U.S. Food and Drug Administration

FDA Warns Long-term Risks with Antibiotic Clarithromycin (Biaxin) in Heart Disease Patients

The antibiotic clarithromycin (brand name: Biaxin) may increase the long-term risk of heart problems and death in patients with heart disease, according to U.S. health officials.

As a result, the federal Food and Drug Administration said Thursday that it’s recommending that doctors carefully weigh the benefits and risks of the drug before prescribing it to patients with heart problems.

The agency said its warning is based on a 10-year follow-up study of patients with coronary heart disease. The study found an unexpected and unexplained increase in deaths among heart disease patients who took clarithromycin for two weeks and were followed for one year or longer.

There’s no clear explanation for how clarithromycin would increase heart disease patients’ risk of death, the FDA said in a news release.

One heart specialist said this type of alert is worth heeding, however.

“It is important for health professionals and pharmacists to identify potential interactions between medications and eliminate prescription errors to prevent this risk,” said Dr. Marcin Kowalski. He directs cardiac electrophysiology at Staten Island University Hospital in New York City.

The FDA said it has added a new warning about this increased risk for heart patients, and is advising doctors to consider prescribing other antibiotics to these patients. The agency added that it will continue to monitor safety reports in patients taking clarithromycin.

The antibiotic is used to treat many types of infections affecting the skin, ears, sinuses, lungs and other parts of the body.

Doctors should talk to their heart patients about the risks and benefits of clarithromycin and alternative treatments. If doctors prescribe clarithromycin to patients with heart disease, they should inform those patients about the signs and symptoms of cardiovascular problems, the FDA said.

And patients with heart disease should tell their doctor about their condition, especially when they are being prescribed an antibiotic to treat an infection.

Heart disease patients should not stop taking their heart disease medicine or antibiotic without first talking to their doctor, the FDA said.

Patients taking the antibiotic should seek immediate medical attention if they experience symptoms of a heart attack or stroke, such as chest pain, shortness of breath or trouble breathing, pain or weakness in one part or side of the body, or slurred speech, the agency said.

Dr. Satjit Bhusri is a cardiologist at Lenox Hill Hospital in New York City.

He said, “Although this study suggests an association between this specific antibiotic, there have not been any direct correlations to increased heart disease.

“I would also extend this to all antibiotics in general. A short course of antibiotic therapy for a bacterial infection should be initiated if indicated by the physician; and a history of antibiotic therapy, at this time, should not be considered a risk factor for heart disease,” he said.

Source: HealthDay

FDA Approves Pill with Sensor that Digitally Tracks if Patients have Ingested their Medication

The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.

Schizophrenia is a chronic, severe and disabling brain disorder. About 1 percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

Abilify MyCite contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify MyCite is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.

Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

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.

Source: U.S. Food and Drug Administration

US FDA Moves to Revoke Claim that Soy Protein Protects the Heart

U.S. regulators Food and Drug Administrators (FDA) want to remove a health claim about the heart benefits of soy from cartons of soy milk, tofu and other foods, saying the latest scientific evidence no longer shows a clear connection.

Monday’s announcement by the Food and Drug Administration marks the first time the agency has moved to revoke a health food claim since it began approving such statements in 1990. The claim that soy protein can reduce heart disease appears on about 200 to 300 products in the U.S., according to industry figures, including popular brands like Silk soy milk.

Calls to WhiteWave Foods Company, which markets Silk brand soy products, were not immediately returned Monday.

The FDA first approved the language about the benefits in 1999 based on studies suggesting soy protein lowered a type of heart-damaging cholesterol in the bloodstream. But some later studies have failed to show a clear link.

One 2005 study by the U.S. government’s Agency for Healthcare Research and Quality found that soy products had little effect on bad cholesterol. The FDA began reevaluating the food claim in 2007 and said Monday “the totality of the evidence is inconsistent and not conclusive.”

The agency will take comments on its proposal for 75 days before moving ahead. If the language is removed, companies may still be able to use a less definitive statement about soy’s benefits by including a disclaimer or description of the mixed evidence.

Consumer advocates backed the proposal, arguing that earlier research misinterpreted soy’s effect on cholesterol.

Bonnie Liebman, a nutrition scientist at the Center for Science in the Public Interest, explained that a person might benefit by replacing red meat with soy, but the benefit would be from the reduction in red meat, not because of anything special in the soy protein.

The FDA estimates it will cost companies between $370,000 and $860,000 in upfront costs to re-label their products, according to a federal filing posted online.

An industry group for soy manufacturers disputed the FDA’s decision and pointed to 12 other countries, including Canada, that have approved health labeling claims making the link between soy protein and heart benefits. The group, Soyfoods Association of North America, said it would make its case to the FDA during the comment period.

Source: abc News


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