Whether you got a tattoo on a whim or after much thought, that ink on your body is fairly permanent. Tattoo removal is possible, but it comes with risks, according to the U.S. Food and Drug Administration, which regulates tattoo ink and pigment, as well as the laser devices used to remove them. State and local authorities typically oversee tattooing practices. The FDA has cleared several types of lasers for tattoo lightening or removal. They are to be used by or under the supervision of a health care professional. The process requires using the correct type of laser, understanding how tissue will react and knowing how to treat the area after the procedure. One challenge with removal is that tattoos are more than skin deep. The needle injects ink into the skin, penetrating the epidermis, or outer layer. And it also deposits a drop of ink into the dermis, the layer underneath. The cells of the dermis are more stable than those of the epidermis, which, the FDA said, means the ink will mostly stay in place for a person’s lifetime. Lasering is the most common method for removing or lightening tattoos, according to the FDA. Laser light energy shatters the tattoo ink into small particles, and the immune system clears these particles over time. Different types of lasers may be used depending on the… read on > read on >
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FDA Gives Approval to Pill to Ease Postpartum Depression
The U.S. Food and Drug Administration on Friday approved a new pill, called zuranolone, that may quickly ease severe postpartum depression and help millions of women regain their emotional equilibrium following childbirth. Taken as a pill once a day for two weeks, zuranolone (Zurzuvae) showed “rapid, significant and sustained” reductions in depressive symptoms when compared to a placebo, according to a recent study of nearly 200 women, the FDA said. These improvements occurred in as few as three days and were still evident 28 and 45 days later. That’s compared to the many weeks it typically takes for standard antidepressants to start taking full effect. “Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” Dr. Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in an agency statement. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.” As many as 1 in 8 women in the United States develops depression just before or after giving birth. “Women report severe sadness or loss… read on > read on >
Lawsuit Against Makers of Ozempic, Mounjaro Claim Meds Caused ‘Stomach Paralysis’
A Louisiana woman is suing the makers of two type 2 diabetes drugs used off-label for obesity, saying they failed to adequately warn about the risk of severe stomach problems. The lawsuit seeks “very significant” but unspecified compensation from the makers of both Ozempic and Mounjaro, said attorney Paul Pennock of the Orlando, Fla.-based firm Morgan & Morgan. Pennock filed the lawsuit Wednesday on behalf of Jaclyn Bjorklund, 44, NBC News reported. The lawsuit against Novo Nordisk and Eli Lilly claims Bjorklund was “severely injured” after taking the two diabetes drugs, which are part of a new class of medication called GLP-1 agonists. Pennock said she is suffering “persistent” vomiting and severe gastroparesis, also known as stomach paralysis. Gastroparesis slows or stops food from moving out of the stomach and into the small intestines. It can be caused by underlying medical issues, including diabetes, according to the American College of Gastroenterology. Infections and some medication can also cause it. The GLP-1 agonists slow food’s movement and have been found to cause some GI issues in clinical trials. Those are listed as side effects on the drug labels. Both Ozempic and Mounjaro have the phrase “delays gastric emptying” on their prescribing information, though they don’t specifically use the word “gastroparesis,” NBC News reported. A U.S. Food and Drug Administration spokeswoman said it was unclear whether the… read on > read on >
Amid Shortages, Federal Agencies Ask Drugmakers to Boost Output of ADHD Meds
While demand for prescription stimulants is surging, a shortage of the drugs persists, so federal officials have stepped in and asked drug companies to ramp up production of the medications. Officials from both the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration (DEA) made the joint request. “The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug or change the distribution of a drug,” FDA Commissioner Dr. Robert Califf and Drug Enforcement Administration leader Anne Milgram wrote in a letter issued Tuesday. “That said, we are working closely with numerous manufacturers, agencies and others in the supply chain to understand, prevent and reduce the impact of these shortages.” The agencies are also asking prescribers to carefully monitor their prescribing practices. “The lack of availability of certain medications in recent months has been understandably frustrating for patients and their families,” Califf and Milgram wrote in their letter. Reasons for the shortage include manufacturing delays by one drugmaker last fall. Meanwhile, demand for prescription stimulants for adults surged during the pandemic, according to a U.S. Centers for Disease Control and Prevention report. The FDA first announced a shortage of Adderall last October; that medication is commonly used for those with attention deficit hyperactivity disorder (ADHD). The DEA limits the amount of… read on > read on >
Pill to Counter Postpartum Depression Looks Good in Trial, May Gain FDA Approval
All eyes are on the U.S. Food and Drug Administration this week as the agency weighs approval of a new pill that may quickly treat and ease severe postpartum depression. Approval of the drug could help millions of women regain their emotional equilibrium following childbirth. The FDA’s decision is expected by Friday. Taken as a pill once a day for two weeks, zuranolone showed “rapid, significant and sustained” reductions in depressive symptoms when compared to a placebo, or dummy pill, according to a recent study of nearly 200 women. These improvements occurred in as few as three days and were still evident 28 and 45 days later, said study author Dr. Kristina Deligiannidis. She is a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in Manhasset, N.Y. As many as 1 in 8 women in the United States develops depression immediately before or after giving birth. “Women report severe sadness or loss of interest in pleasurable activities and relationships, have significant guilt, often about not being a good enough mother or partner, low energy, poor concentration and indecisiveness, loss of appetite and irritability,” Deligiannidis said. Many also say they feel overwhelmed and are anxious, especially over the baby’s well-being, she added. Some women may start to believe that their family would be better off if they were dead, she… read on > read on >
Statins’ Effectiveness May Rise With Patient Age: Study
Elderly adults who start on a statin may see an even bigger drop in their “bad” cholesterol levels than their younger counterparts do, a new study suggests. The study, of nearly 84,000 Danish patients, found that those age 75 and up typically showed a stronger response after starting a low- to moderate-dose statin: Compared with the typical 50-year-old, their LDL cholesterol dipped by a few more percentage points. Researchers said the findings suggest that older patients could begin with a lower-dose statin, to minimize the chances of side effects. While statins are considered safe, they may cause problems like muscle pain or elevated blood sugar in some people. The odds of side effects generally go up with higher statin doses, and older adults are typically more vulnerable than their younger counterparts. So, starting at a lower statin dose could be “an appealing alternative” for older patients, said senior researcher Dr. Marie Lund, of the Statens Serum Institute in Copenhagen. She added, however, that there are additional things to consider — including an older person’s existing health conditions and the need for lowering the risk of a future heart attack or stroke. Statins are among the most widely used medications globally, spurred by studies showing that along with cutting levels of “bad” LDL cholesterol, they help prevent heart attacks and strokes. But clinical trials generally include… read on > read on >
Kombucha May Help Control Blood Sugar in Folks With Type 2 Diabetes
Kombucha is a fermented tea that many folks believe offers numerous health benefits — and new research suggests they may be right. Though the study was small — 12 participants — it found that kombucha may help lower blood sugar levels in people with type 2 diabetes. Fermented with bacteria and yeasts, the drink has been consumed in China since 200 B.C. but it has been embraced in the United States only since the 1990s, researchers said. “Apple cider vinegar was really taking off and people were talking about it all the time and kombucha,” said study author Dr. Daniel Merenstein, director of family medicine research at Georgetown University in Washington, D.C. “And they have a farmers market at Georgetown where they sell kombucha, so we just thought, this kombucha is more tasty, easier to drink than apple cider vinegar … so that’s really what got us to do this study.” Not only was it easy to take, participants who drank kombucha had significantly lower average fasting blood sugar levels after drinking it for four weeks — 116 versus 164 at the study’s start, researchers found. Participants who drank a similarly flavored placebo also saw their blood sugar drop — from 162 to 141 — but researchers said that change was not statistically significant. For the study, participants downed 8 ounces of kombucha or a… read on > read on >
New Clues to Treating a Disease That Prevents Children From Swallowing, Eating
Children who have a chronic immune system disease that can prevent them from eating may eventually have a new treatment, decades after the condition was first identified. “Parents and doctors may not be aware of this, but this is a very prominent and serious disease in the pediatric population, and it is increasing in number because it is directly related to food allergens, which are also on the rise,” said lead study author Dr. Anil Mishra, director of the Eosinophilic Disorder Center at the Tulane University School of Medicine in New Orleans. “In this study, we show that after treating the disease in animals, the disease is gone and completely in remission,” he said in a university news release. Eosinophilic esophagitis (EoE) can be triggered by food or airborne allergies. This causes eosinophils, which are white blood cells, to build up in the lining of the esophagus. This reaction causes the esophagus to shorten and the esophageal wall to thicken, which can make it difficult to swallow and cause food to get stuck in the throat. The study, conducted in mice, found that the disease is caused by interleukin-18 (IL-18), a protein involved in the innate immune response. It can cause inflammation if produced in excess. An allergen entering the body activates a pathway that leads to the release of pro-inflammatory proteins like IL-18 and… read on > read on >
Key Ingredient in Breast Milk Could Do Wonders for Baby’s Brain
A micronutrient in human breast milk may provide significant benefit to developing newborn brains, according to new research that sheds light on the link between nutrition and brain health. Scientists looked at this sugar molecule in rodents and in human neurons. They said the micronutrient, called myo-inositol, may lead to improved infant formulas. “The current research does indicate that for circumstances where breastfeeding is not possible, it may be beneficial to increase the levels of myo-inositol in infant formula,” said study co-author Thomas Biederer. Myo-inositol may also play a part in the aging brain, according to the research conducted at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University in Boston. “Forming and refining brain connectivity from birth is guided by genetic and environmental forces as well as by human experiences,” Biederer, a senior scientist on the neuroscience and aging team at the HNRCA, said in a Tufts news release. He is also a faculty member at the Yale School of Medicine. “As a neuroscientist, it’s intriguing to me how profound the effects of micronutrients are on the brain,” Biederer said. “It’s also amazing how complex and rich human breast milk is, and I now think it is conceivable that its composition is dynamically changing to support different stages of infant brain development.” The researchers compared human milk samples collected… read on > read on >
Low-Fiber Diet During Pregnancy May Harm Baby’s Brain
Too little fiber in Mom’s diet during pregnancy may slow a baby’s mental development, Japanese research suggests. Animal studies have found that a low-fiber diet during pregnancy slows brain nerve function in offspring. The new study, published July 27 in the journal Frontiers in Nutrition, shows the same effect in humans. “Most pregnant women in Japan consume far less dietary fiber than what is the recommended intake,” said study leader Kunio Miyake, an assistant professor of environmental genetics at the University of Yamanashi. “Our results provided reinforcing evidence that undernutrition during pregnancy is associated with an increased risk of neurodevelopmental delay in children,” Miyake said in a journal news release. For the study, the researchers compared the development of children whose mothers ate the most fiber to those of mothers who consumed less fiber. The study included 76,000 mother-infant pairs who were part of the Japan Environment and Children’s Study. Compared with children whose mothers ate the most fiber during pregnancy, those whose moms ate the least were more likely to show neurodevelopmental delays. The delays affected communication, problem-solving and personal-social skills. Researchers also saw delayed development of movement and coordination. In Japan, the recommended daily dietary fiber intake is 18 grams; in the United States and Canada, it is 28 grams. “Our results show that nutritional guidance for pregnant mothers is crucial to reduce… read on > read on >