It’s important to ask questions when your doctor or dentist writes you a new prescription. This is especially true for opioid pain medications, such as hydrocodone, oxycodone or morphine. While these drugs are approved by the U.S. Food and Drug Administration for acute and chronic pain, they can have serious side effects, including addiction and even death. Misuse of opioids have led to the current drug overdose crisis in the United States. The majority of overdose deaths in this country involve opioids, according to the U.S. Centers for Disease Control and Prevention. The FDA offers some tips for using these medications safely. Start by asking your doctor how long your pain is likely to last and what medication is being prescribed. If the drug is an opioid, ask if there are non-opioid alternatives. If your doctor decides an opioid is best, ask how long you should take the medication. Find out when and how to stop using it. Ask for the lowest dose possible for the shortest time needed and in the smallest quantity, the FDA advised. Also ask about a follow-up appointment. While prescription opioids can be safe and effective, using them in a way that differs from what was prescribed or for non-medical reasons can lead to dependence, addiction and even death, the FDA cautioned. Side effects from opioid use include dizziness, drowsiness,…  read on >  read on >

The U.S. Food and Drug Administration on Friday approved the first nonhormonal medication aimed at easing menopause hot flashes. The new pill, called Veozah (fezolinetant), is from a class of drugs called neurokinin 3 (NK3) receptor antagonists. It targets a specific brain neuron that’s thought to be set off balance as estrogen levels naturally decline during menopause. “It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature,” the FDA explained in a news release issued Friday. “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, who directs the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine at the agency’s Center for Drug Evaluation and Research. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women,” she said in the news release. According to the FDA, over 80% of menopausal women experience sudden, often debilitating hot flashes lasting several minutes that can be accompanied by sweating, flushing and chills. While estrogen-based hormone replacement therapy has long been used to help ease these symptoms, long-term use has been linked to a heightened risk for breast cancer and stroke. In addition, “some…  read on >  read on >

Outside advisors for the U.S. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions. Although most of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) and children (17:5), key questions linger about whether more data is needed from its maker, ARS Pharmaceuticals, CBS News reported. But Richard Lowenthal, co-founder, president and CEO at ARS, said in a company statement following the vote that, “We believe our clinical data from more than 600 individuals demonstrate Neffy’s absorption-enhancing nasal spray technology is comparable to injectable products in delivering potentially lifesaving epinephrine, but with unique advantages of being small, needle-free and conveniently sized.” Lowenthal added, “We are committed to making it easier for patients and caregivers to carry and administer epinephrine without the anxiety and hesitation associated with using a needle-based device.” Neffy delivers a 2-milligram dose of epinephrine. Instead of large clinical trials, the drug company compared its product to already approved injectable epinephrine products, such as the EpiPen. It showed the results for Neffy were neither substantially higher or lower than injectable epinephrine. “Patients need options — with different administration methods — to facilitate actual epinephrine use in an emergency event,” Dr. Carlos Camargo, a professor of emergency medicine at Harvard Medical School in Boston, said in the company’s news release.…  read on >  read on >

(HealthDay News) – Millions of Americans take cholesterol-lowering drugs called statins, but a new study finds Black and Hispanic adults get the drugs less often than white people do. “This adds to the known racial and ethnic disparities already highly prevalent in heart disease,” said lead author Dr. Ambarish Pandey, an assistant professor of internal medicine at UT Southwestern Medical Center in Dallas. “These findings have the potential to affect how we screen for and treat people who do not have heart disease but may have risk factors such as high blood pressure, high cholesterol and smoking,” he said in a medical center news release. Using national survey data and examining risk factors for heart disease, researchers found about 38% of white participants used statins like Lipitor (atorvastatin) and Zocor (simvastatin) compared with about 24% of Hispanic and Black participants. Statins are among the most prescribed drugs in the United States. Having health insurance and regular access to routine health care were associated with higher statin use. Rates of heart disease are higher in Black and Hispanic adults than white adults, according to past research, so race and ethnicity are considered factors in your individual risk of developing heart disease. Data for the study came from the 2013-2020 National Health and Nutrition Examination Survey (NHANES). A subset of participant records was selected to represent the…  read on >  read on >

The U.S. Food and Drug Administration on Thursday finalized the elimination of certain restrictions that prevented healthy gay and bisexual men from donating blood. Instead of requiring men who have sex with men or the women who have sex with them to abstain for sexual contact for three months, the FDA has created an individual risk assessment for all donors. These questions are meant to reduce the risk of transfusion-transmitted HIV. “The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release. “The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations, and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place,” Marks added. These policies are in alignment with what already happens in some other countries, including the United Kingdom and Canada, according to the FDA. LGBTQ advocates said the decision was much needed. “The FDA’s decision to follow science and issue new recommendations…  read on >  read on >

A medication to treat agitation in Alzheimer’s patients now has approval from the U.S. Food and Drug Administration. The FDA gave supplemental approval to Otsuka Pharmaceutical Company Ltd., and Lundbeck Inc. for Rexulti (brexpiprazole) oral tablets on Thursday. Rexulti is the first FDA-approved treatment for these symptoms. “Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease. ‘Agitation’ can include symptoms ranging from pacing or restlessness to verbal and physical aggression,” said Dr. Tiffany Farchione, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” she added in an agency news release. The approval followed two 12-week studies. Participants were between 51 and 90 years of age, and had a probable diagnosis of Alzheimer’s dementia, along with the type, frequency and severity of agitation behaviors that require medication. Patients in the first study received either 1 or 2 milligrams (mg) of Rexulti. In the second study, they received 2 or 3 mg of Rexulti. Over the 12 weeks, researchers looked for a change from baseline in a patient’s Cohen-Mansfield Agitation Inventory (CMAI) score. The inventory is a tool that uses caregivers’ input to rate the frequency of agitation on a…  read on >  read on >

A “peanut patch” worn on the skin may help protect toddlers who have potentially life-threatening peanut allergies, a new clinical trial shows. The patch is a form of immunotherapy, which means it exposes peanut-allergic children to tiny bits of peanut protein over time — with the goal of training the immune system to better tolerate it. In the trial, researchers found that of toddlers who wore the peanut patch every day for a year, two-thirds showed a significant reduction in their sensitivity to peanut protein: They were able to eat the equivalent of one to four peanuts without suffering an allergic reaction. While that might sound like peanuts, experts said that level of tolerance is important. The goal of immunotherapy is to prevent a severe reaction should a child accidentally ingest a small amount of peanut, said Dr. Alkis Togias, of the U.S. National Institute of Allergy and Infectious Diseases. “This is a positive study,” said Togias, who wrote an editorial published with the findings on May 10 in the New England Journal of Medicine. The patch tested in the trial, called Viaskin, is being developed by French biotech company DVB Technologies, which funded the research. It is not yet approved by the U.S. Food and Drug Administration. If it does win approval, Togias said, “I think that would only be a good thing.” An…  read on >  read on >

In a unanimous vote, a panel of expert advisors to the U.S. Food and Drug Administration on Wednesday endorsed the over-the-counter sale of a birth control pill, a recommendation that will likely pave the way for far greater access to contraception for Americans. Opill, as the pill is called, was first approved by the FDA in 1973. There is no precise information available on how much Opill will cost if sold over the counter (OTC), but Opill manufacturer Perrigo said recently that it is committed to making the medication affordable. “Today’s vote to recommend a switch of Opill to OTC is a new, groundbreaking chapter in reproductive health. Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Perrigo President and CEO Murray Kessler said in a company news release. “We are motivated by the millions of people who need easy access to safe and effective contraception.” The American Medical Association, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists (ACOG), and other medical organizations already support over-the-counter access to hormonal contraception without age restrictions. And the FDA panel agreed. “I do believe this is a viable option to support access and will support the prevention of unintended and unwanted pregnancies,” said panel member Jolie Haun, a researcher with the U.S. Department of Veterans…  read on >  read on >

As a U.S. Food Drug Administration advisory panel prepares to weigh whether to recommend that a birth control pill be sold over the counter in this country, a coalition of advocates on Monday called attention to the safety and effectiveness of the medication. If approved, Opill, a daily progestin-only birth control pill, would become the first such drug sold over the counter in the United States. Opill was first approved by the FDA in 1973. During a media briefing on the coming decision, the Free the Pill coalition said it hopes this pill will be fully covered by insurance and available to people of all ages and backgrounds without a prescription. Meanwhile, the FDA’s expert panel will hold a two-day meeting, starting on Tuesday, to decide whether to recommend allowing the Opill to be sold without a prescription. There is no precise information available on how much Opill will cost if sold over the counter, but Opill manufacturer Perrigo said in a recent statement that it is committed to making it affordable. The American Medical Association, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists (ACOG), and other medical organizations support over-the-counter access to hormonal contraception without age restrictions. The Free the Pill coalition has been advocating for over-the-counter status for birth control pills since 2004, citing the many barriers that…  read on >  read on >

What puts kids at risk for pediatric inflammatory bowel disease (IBD) and what could help prevent it? A review of 36 observational studies that included 6.4 million kids offers some key clues. Taking antibiotics at an early age, eating a Western diet and living in a more affluent family were associated with an increased IBD risk. But living in a household with pets and siblings and eating plenty of veggies were linked to a lower risk. “Pediatric IBD cases are rising globally, and approximately 1 in 4 of all IBD cases are now diagnosed before age 21,” said lead author Nisha Thacker, a gastrointestinal dietitian who did the meta-analysis as part of her doctoral studies at the University of Newcastle in Australia. IBD is marked by abdominal pain, diarrhea and blood in the stools, indicating that parts of the intestinal tract have become inflamed. The new analysis, presented Sunday at a conference of the American Gastroenterological Association, found that kids who took antibiotics before age 5 had triple the risk for pediatric IBD. Their risk was 3.5 times higher if they had received four or more courses of antibiotics by that age. Exposure to secondhand smoke doubled IBD risk. Surprisingly, lower economic status appeared to have a protective effect: It was associated with a 65% lower risk of IBD. Exposure to animals and having only…  read on >  read on >