Family Dollar is recalling certain Advil products after some of its locations failed to store the drugs at proper temperatures, the U.S. Food and Drug Administration said.
The affected products were shipped to the discount chain’s outlets from around June 1, 2022 through March 31, 2023.
Family Dollar kept the Advil bottles “outside of labeled temperature requirements,” the FDA said in a notice Thursday. Ibuprofen, commonly known by the brand name Advil, must be stored between 68 degrees and 77 degrees, the drugmaker’s website said.
The recall notice did not specify how many stores would pull the products off their shelves, nor did it say where those outposts were located. It also did not disclose the number of products being recalled.
Owned by Dollar Tree, Family Dollar has not reported any consumer complaints or illnesses in connection with the recalled products. The company was not immediately available for comment.
The company issued the recall for the following Advil formulations:
0901458 ADVIL 200MG TABLET 100CT
0901839 ADVIL 200 MG CAPLET 24 CT
0902867 ADVIL DUAL ACTION 36CT CAPLET
0913023 ADVIL TABLET 50CT
0916071 ADVIL LIQUID GEL 40 CT
0999259 ADVIL TABLET 6CT
0999841 ADVIL LIQUI GEL MINIS 20CT
Consumers with questions regarding the recall can call Family Dollar Customer Service at 844-636-7687 between 9 a.m. and 5 p.m. Eastern time. The FDA said consumers should contact their physician or health care provider if they have experienced any problems that may be related to the use of these products.
Adverse reactions or quality issues experienced with the use of these products should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, or by regular mail or fax using this downloadable form or by calling 1-800-332-1088 to request a form.
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Novo Nordisk is holding back low doses of Wegovy, its recently approved obesity medication, in the U.S. to conserve supplies for patients already using the drug, the company said Thursday.
The Danish drugmaker is supplying “limited quantities” of 0.25 mg, 0.5 mg and 1 mg dose strengths to wholesalers for distribution to retail pharmacies, according to the statement. The holdback is a move to ensure existing patients have “continuity of care” amid the booming demand, a company spokesperson told the Wall Street Journal.
The Food and Drug Administration (FDA) approved Wegovy as a weight-management treatment in 2021. Like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, Wegovy belongs to a class of drugs known as GLP-1 agonists that have taken the weight-loss industry by storm.
Endorsements by celebrities on social media touting the drugs’ powerful weight-loss effects have fueled nationwide shortages for people who rely on the life-saving medications for other health issues, such as Type 2 diabetes.
“Today we are serving hundreds of thousands of U.S. patients with Wegovy,” the company said in the announcement. “However, trends indicate that demand for Wegovy in the U.S. will exceed our current supply capacity.”
Working on expanding supply
The Danish drugmaker is working to gradually expand its supply capacity by pausing promotions for the drug and closely managing shipments to wholesalers in the U.S., the company said.
Novo Nordisk did not immediately reply to CBS MoneyWatch’s request for comment.
Adult obesity rates in the U.S. have skyrocketed over the past two decades. The U.S. adult obesity rate jumped from 30.5% in 1999 to 41.9% in 2020, data from the National Health and Nutrition Examination Survey (NHANES) shows. In addition, the prevalence of severe obesity nearly doubled to 9.2% over the same time period.
The prevalence of obesity in the states makes the U.S. an ideal market for Novo Nordisk’s weight loss drugs — and it shows in the company’s earnings. Sales for its North America operations increased 47%, according to the company’s financial report for the first quarter of 2023.
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Pharmaceutical giant Eli Lilly is requesting fast-track approval from the Food and Drug Administration for its Type 2 diabetes medication tirzepatide to be sold as a weight loss drug. The company said that new studies have shown promising results. Nikki Battiste has more.
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A new proposed bill in California is looking to ban five chemicals frequently found in candies and snack foods — all of which are currently banned in the European Union — claiming that they could be dangerous for consumers.
AB 418, which is sponsored by Democratic California Assemblymembers Jesse Gabriel and Buffy Wicks, targets Red Dye No. 3, titanium dioxide, potassium bromate, brominated vegetable oil and propylparaben. The bill would prohibit the manufacture, sale or distribution of any food product in California containing those ingredients.
In the U.S., the ingredients can be found in a variety of common processed foods, including breakfast cereals, candy, soda, cottage cheese and trail mix.
Gabriel in a press release claimed the targeted substances can be toxic for consumers.
“Californians shouldn’t have to worry that the food they buy in their neighborhood grocery store might be full of dangerous additives or toxic chemicals,” Gabriel said. “This bill will correct for a concerning lack of federal oversight and help protect our kids, public health, and the safety of our food supply.”
The lawmakers’ statement also discussed how chemicals like these are used and why they are approved in the U.S., despite being banned in other countries.
“Currently, there are thousands of chemicals added to food to make it last longer, taste better, and appear more enticing,” the news release said. “Shockingly, most of these chemicals have never been independently evaluated by the Food and Drug Administration (FDA) or were last reviewed decades ago.”
These chemicals are allowed to be used in U.S. food because of the “GRAS” rule, which stands for “Generally Recognized As Safe.”
Typically, the FDA requires all food additives to be reviewed before they can enter the country’s food supply. But, GRAS allows manufacturers to bypass the reviews if the food additive in question is “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.”
Gabriel said that, because of that rule, “chemical companies have added new substances to the food supply with almost no meaningful federal oversight.”
Supporters of the bill have noted that some products with these specific food additives omit them when the products are sold in other countries.
“Why are these toxic chemicals in our food?,” said Susan Little of the Environmental Working Group. “It makes no sense that the same products food manufacturers sell in California are sold in the E.U. but without these toxic chemicals.”
If the bill passes, California would be the first and only state to ban foods with the specific additives.
A federal judge in Texas is hearing arguments in a case challenging the FDA’s approval of mifepristone, a medication used in abortion pills, over 20 years ago. CBS News legal contributor Jessica Levinson, a professor at Loyola Law School, joined CBS News to outline the next steps in the case, how the lawsuit was brought about, and the impact it could have.
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Pfizer said Friday that the Food and Drug Administration has approved a new nasal spray to treat migraines.
Zavzpret, a branded formulation of the generic drug zavegepant, is the “first and only” calcitonin gene-related peptide receptor antagonist nasal spray for treating migraines with or without an aura, or sensory disturbances such as flashes of light that can accompany a migraine, the drugmaker said.
Zavzpret began working to treat migraine symptoms in as little as 30 minutes and provided some relief for up to 48 hours after the last administered dose, Pfizer said, citing a March study published in The Lancet. A 10mg dose of the drug proved more effective than a placebo at relieving pain and other migraine symptoms, the study found.
Pfizer said it plans to make the drug available in pharmacies in July.
Angela Hwang, chief commercial officer and president of Pfizer’s global biopharmaceuticals business, said in a statement that Zavzpret provides another option for the many people who suffer migraines.
Migraines are moderate or severe headaches that can cause a throbbing pain usually occurring on just one side of the head, according to John Hopkins Medicine. Other symptoms may include nausea, vomiting, and sensitivity to light and sound.
Migraines affect more than 10% of people globally, with people between the ages of 20 and 50 most likely to experience the condition, according to JAMA Network, an American Medical Association-published journal. They are the sixth-highest cause worldwide of years lost to disability, a measure of the amount of time individuals suffer from a lower quality of life due to a disability, according to the World Health Organization.
The global migraine drug market was worth $3.9 billion in 2021. Its value is expected to hit $5.4 billion by 2027, according to 2022 report from market research firm IMARC Group.
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The Food and Drug Administration has issued a warning about a shortage in albuterol as well as the active ingredients used to manufacture Adderall. Albuterol is used to treat asthma, while Adderall is used to treat ADHD. Meg Oliver has more.
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London — Major drug store chains in the United Kingdom plan to start selling the weight loss drug Wegovy, a different version of its hugely popular Ozempic brand, this year, as the company that makes both says it’s working to expand supplies of the popular semaglutide medications to Europe.
Semaglutide works by mimicking the action of a hormone that makes people feel full, blunting their appetites so they eat less. Ozempic is marketed and prescribed to treat Type 2 diabetes, but its side effect of dramatic weight loss has made it popular among celebrities for that purpose. Wegovy, made by the same Denmark-based pharmaceutical company Novo Nordisk, is marketed specifically for weight loss and comes in higher doses.
Britain’s National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending Wegovy for people living with obesity, and its final guidance is expected on March 8. That guidance will serve as a formal instruction to Britain’s National Health Service to start providing the drug to patients who need it, a NICE spokesperson told CBS News.
“We know that management of overweight and obesity is one of the biggest challenges our health service is facing with nearly two thirds of adults either overweight or obese. It is a lifelong condition that needs medical intervention, has psychological and physical effects, and can affect quality of life,” Helen Knight, program director at the center for health technology evaluation at NICE, said in a statement.
Jo Dent, an NHS worker who visited a private doctor to obtain a prescription for Ozempic late last year after struggling to lose weight, told CBS News that semaglutide has helped her reshape her relationship with food. She said making it more readily available would be a good thing for the country’s health service.
“I do think it would support people to be less of a burden on the NHS, in terms of the challenges of obesity and what that means for other health conditions,” she said. “It’s not a quick fix and it’s not the only answer, but actually it will help you if you’re serious about wanting to lose weight.”
Wegovy, an injectable prescription medicine, can help obese or overweight adults with weight-related medical problems lose weight.
Novo Nordisk
At least one major drug store chain in the U.K. plans to start prescribing and selling Wegovy privately through its online doctor service this year. Boots, the biggest national pharmacy chain, is already offering an online prescription service for the medication, while competitor Superdrug has set up a waiting list.
Declining to offer specific countries or timings, a spokesperson for Novo Nordisk said the company was “really looking to make sure that we only launch if we can provide the product. So obviously, we have ramped up our supply chain. We’ve invested quite a lot, where our manufacturing is now running 24-hours, seven days a week.”
The spokesperson said even after the NICE guidelines in the U.K. are published next week, Wegovy will only be available to the NHS once the company has sufficient supplies to offer it to the market.
“We don’t have concrete launch timings,” the spokesperson told CBS News. “We’re just looking to make it available as soon as possible.”
Novo Nordisk launched Wegovy in Norway and Denmark at the end of last year, and the spokesperson said the company expects to launch in a number of additional European countries in 2023.
“We’re just focused on, obviously, production for Europe and continuing to supply the U.S.,” the spokesperson told CBS News.
NICE said the list price of Wegovy in 0.25 mg, 0.5 mg and 1.0 mg doses was 73.25 pounds (about $88) per pack of four pre-filled injection pens, but that if it becomes available on the NHS, it will either be free or cost patients the standard prescription fee of about $10 per order, depending on the cost structure.
In the U.S. the same pack of four Wegovy injection pens has a list price of $1,349, but some health insurance plans will cover at least some of that cost.
In the U.K., Wegovy will only be available to obese adults who have at least one additional condition, such as heart disease or high blood pressure. It must be prescribed by a doctor or someone with specialist qualifications.
Cristina Ochoa often worries if the food she’s feeding her two young kids is safe, even after carefully reading ingredient labels.
“Some ingredients I have no idea what they are, how to pronounce them,” she said. “I want the best for my children. I would think that as a society we want the best for our children.”
There are more than 10,000 chemicals and additives allowed in food in the United States, often in small amounts. But many haven’t been evaluated by the Food and Drug Administration in decades. The majority are safe, but some chemicals allowed in the U.S. have been banned overseas after research has linked them to cancer and developmental or behavioral issues.
Democratic Congresswoman Jan Schakowsky, of Illinois, introduced a bill requiring the FDA to review certain chemicals banned overseas and to close what’s known as the “generally recognized as safe” loophole. The loophole allows companies to skip an extensive safety review when adding many new chemicals to food.
Schakowsky said the food industry is essentially policing itself.
“We look around the world and you see what the other countries are doing to protect their consumers, we are far behind,” she said. “We need to put the F back into the Food and Drug Administration.”
CBS News has obtained a copy of proposed legislation in California that would make it the first U.S. state to ban five common chemicals — brominated vegetable oil, potassium bromate, propylparaben, red dye 3 and titanium dioxide — from all goods sold, distributed or made in the state.
“They’re going to have to change their recipes, get rid of these chemicals, and hopefully that’s something that’s going to have impacts far beyond our borders here in the state of California,” said Jesse Gabriel, a California state assemblymember.
The FDA told CBS News that its scientists keep up to date on food safety research, but that it’s also the responsibility of the food industry to make sure the substances used are safe.
Ochoa says the FDA needs to do more.
“We’re trusting them,” she said. “This is the food that is feeding our future. I want them to be held to a higher standard.”
Abbott Laboratories is facing investigations by the Securities and Exchange Commission and the Federal Trade Commission (FTC) in connection with its formula business, the company revealed in a recent SEC filing.
The developments are the latest in a series of inquiries into the factors that precipitated the company’s Michigan factory shutdown and kickstarted a nationwide formula shortage.
Abbott received a subpoena from the SEC’s Enforcement Division soliciting “information relating to Abbott’s powder infant-formula business and related public disclosures” last December, the company said.
Then, in January, the FTC issued the manufacturer a civil investigative demand connected with an investigation into companies that bid for infant formula contracts with federal nutritional programs such as the Special Supplemental Nutrition Program for Women, Infants, and Children, or WIC, program. That same month, Abbott also confirmed the U.S. Justice Department is investigating operations at its Michigan plant.
Abbott Laboratories made headlines in February 2022 after the FDA sent inspectors to Abbott’s infant formula manufacturing facility in Sturgis, Michigan, to investigate a whistleblower report alleging the company had engaged in activities to cover up substandard cleaning practices at its facilities and had shipped untested and potentially contaminated formula to retailers.
Abbott recalled select Similac, EleCare and Alimentum as well as powdered infant formulas manufactured at the Sturgis plant, and closed down the factory later that month when investigators found evidence of cronobacter sakazakii bacteria at the facility. The recall came shortly after four infants drank Abbott’s formula and contracted cronobacter infections; two of the infants died.
At least two dozen families are now suing Abbott over the allegedly contaminated formula. Abbott’s representatives say there’s no conclusive evidence linking its formula to the infants’ illnesses, as none of the cronobacter strains found at their plant matched samples genetically sequenced from the sick infants.
Food and Drug Administration Commissioner Robert Califf said his agency’s inspections found conditions at Abbott’s Sturgis, Michigan plant “shocking” and “egregiously unsanitary.”
The Michigan plant closure took a massive toll on families nationwide, forcing parents and caregivers to turn to local food pantries to procure formula and spurring collection initiatives at breast milk banks.
Abbott Nutrition, a subdivision of multinational health conglomerate Abbott Laboratories that oversees the conglomerate’s formula business, controlled 40% of the baby-formula market in the U.S. at the time of its Michigan plant shutdown last year.
Public health organizations have for decades criticized formula makers for aggressively marketing their products to the detriment of breastfeeding. The World Health Organization last year detailed how big formula companies use aggressive marketing practices to promote the use of infant formula over breast milk, leaving many families dependent on commercial products and vulnerable to formula shortages. A series of papers published in the medical journal The Lancet this month describes what its authors call the commercial milk industry’s “underhand marketing strategies, designed to prey on parents’ fears and concerns, to turn the feeding of infants and young children into a multibillion-dollar business.”
The Food and Drug Administration on Thursday said it is unable to regulate CBD products under its current structure because the hemp- or marijuana-derived ingredient hasn’t been shown to be safe enough for food or supplements.
“[I]t is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” FDA Deputy Commissioner Dr. Janet Woodcock said in a statement.
She added, “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”
Instead, the FDA called on Congress to create new rules for the massive and growing market for hemp- or marijuana-derived products, which have become increasingly popular in lotions, tinctures and foods and is projected to reach sales of $22 billion by 2030. Meanwhile, the legal status of CBD products has been murky in the U.S.
Questions remain about CBD’s effects on the liver, the male reproductive system and on pregnant women and children, the FDA statement said.
FDA oversight
The FDA has oversight of CBD because it is the active ingredient in an approved prescription drug, Epidiolex, used to treat two rare seizure disorders. Under FDA regulations, a drug can’t be added to food or sold as a dietary supplement if officials haven’t determined if it’s safe or effective for other conditions.
New rules could include clear labels, regulations regarding contaminants, limits on CBD levels and requirements, such as a minimum purchase age. Regulations are also needed for CBD products for animals, the agency said.
CBD often comes from a cannabis plant known as hemp, which is defined by the U.S. government as having less than 0.3% THC, the compound that causes marijuana’s mind-altering effect. CBD doesn’t cause a high, but fans of CBD products claim benefits including relief for pain and anxiety.
The FDA’s action comes after repeated calls from lawmakers, advocates and consumer groups for CBD to be allowed in foods and supplements.
“Kicking the can”
The agency also denied three petitions from advocacy groups that had asked the agency to allow products that contain the hemp ingredient to be marketed as dietary supplements.
Steve Mister, chief of the Council for Responsible Nutrition, a trade group for the supplement industry and one of the petitioners, expressed dismay at the denial and said the FDA was “kicking the can down the road while ignoring the realities of the marketplace” by referring the issue to Congress.
“FDA has repeatedly disregarded evidence demonstrating safety that is relevant to CBD at the levels commonly used in supplements and continues to rely heavily on safety concerns related to high dosage Epidiolex to support the agency’s inaction,” Mister said in a statement.
The FDA will continue to take action against CBD and other cannabis products to protect the public, Thursday’s statement said. The agency has sent warning letters to some companies making health claims for CBD.
Marijuana itself remains illegal at the federal level in the U.S., although it has been allowed for medical and recreational use in many states, including use in pot-laced food and drinks.
The Food and Drug Administration released draft guidelines Tuesday that detail the maximum amount of lead that can be found in baby food products, and is part of the organization’s Closer to Zero initiative aiming to reduce childhood exposure to harmful contaminants in food.
“The proposed action levels would result in significant reductions in exposures to lead from food while ensuring availability of nutritious foods,” said the FDA on Twitter.
Prolonged exposure to lead may result in “learning disabilities, behavior difficulties, and lowered IQ,” as well “immunological, cardiovascular, renal, and reproductive and/or developmental effects,” said the FDA in the report, while explaining that lead is “widely present” in the environment both naturally, and in part due to human activities.
“Because lead may be present in environments where food crops used to make food intended for babies and young children are grown, various foods may contain small amounts of lead,” said the FDA. “Potential sources of lead in food include contaminated soil where crops are grown, contaminated water, atmospheric deposition from industrial activities, and old lead-containing equipment used to process food.”
Today we announced draft guidance for industry on action levels for lead in processed foods that are intended for babies and children under 2 years of age, to help reduce potential health effects in this vulnerable population from dietary exposure to lead. https://t.co/XjDF76QW3Spic.twitter.com/51ufGLr4RO
“Today’s announcement to set tougher standards for toxic metals in baby foods is important progress by the FDA,” Scott Faber, senior vice president of government affairs at the nonprofit Environmental Working Group, said in a statement.
The new guidance — which is not mandatory for food manufacturers — outlines the following amounts as being acceptable in baby food for children under the age of two:
10 parts per billion, or ppb, for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
20 ppb for root vegetables (single ingredient); and
20 ppb for dry infant cereals.
“The purpose of this guidance is to provide information to industry on the action levels for lead in food intended for babies and young children,” said the FDA in the guidance.
“…our Closer to Zero action plan outlines other actions we will take to further reduce lead (as well as other toxic elements) in food and our expectation is that industry will strive for continual reductions over time.”
“The action levels released today for lead, the first toxic heavy metal the agency is addressing, are not enough to protect the next generation of babies from harmful heavy metals in their food,” read a statement from advocacy organization Healthy Babies Bright Futures.
The group also pointed out that the FDA’s new regulations do not apply to teething biscuits, which its studies have shown account for seven of the 10 highest lead levels in the more than 1,000 food tests the organization has conducted.
Young mother grocery shopping
d3sign / Getty Images
“These proposed action levels don’t do enough to get us closer to zero,” said Charlotte Brody, the organization’s national director.
“The action levels released by the FDA today for the most part put a rubber stamp on the status quo — signifying that the current levels of lead in baby food are ‘close enough.’ Why has the FDA’s Closer to Zero program spent years to create proposed guidance that won’t do enough to make baby food safer?”
Jane Houlihan, the group’s research director, told CBS News, “As it stands, it appears that FDA is choosing round numbers it thinks the industry can easily meet. But there are plenty of actions companies can take to lower levels, from testing and choosing fields with lower soil lead levels, to adjusting soil additives and choosing crop varieties that accumulate less lead.”
“We’ve seen with infant rice cereal and apple juice (two foods with arsenic and/or lead limits in place already) that when FDA issues action levels, industry can significantly reduce the amounts of these toxic metals in their products,” Houlihan said.
According to an analysis commissioned by the group, children under two years of age in the U.S. lose over 11 million IQ points from exposure to heavy metals in food.
Last year, an HBBF study found that 94% of manufactured baby foods, family foods and homemade purees made from purchased raw foods contained detectable amounts of one or more heavy metals — lead, arsenic, mercury and cadmium.
Lead was also found in 90% of manufactured baby food, 80% of store-bought family food and homemade purees.
Devastated by post-traumatic stress disorder, Jonathan Lubecky tried to take his own life in 2006.
“I put a loaded nine-millimeter to my temple, and I pulled the trigger,” he said. “That was the first suicide attempt that I had. I’ve had a total of five.”
After his last attempt in 2013, the Iraq War veteran began participating in a clinical trial of MDMA — the active ingredient in ecstasy — during sessions with specially trained therapists.
“MDMA mutes the amygdala, which is your fight or flight response,” Lubecky said. “Your emotions stay in this happy medium range that they need to be in for the therapy to work.”
Lubecky says he’s now living a life free from PTSD.
“I feel normal again,” Lubecky said. “My world changed. This therapy is the sole reason that my son has a father instead of a folded flag.”
Research organization MAPS Public Benefit Corporation first began clinical trials of MDMA for PTSD in 2003. It announced the findings of its latest trials this month.
“88% of the people, had clinically significant decrease in their PTSD symptoms,” said MAPS PBC CEO Amy Emerson. “67% of them lost their PTSD diagnosis.”
MAPS PBC plans to submit its latest results for publication, and, later this year, ask the Food and Drug Administration to approve MDMA as a prescription medication, in combination with therapy.
In response to potential backlash over the use of ecstasy, a lead researcher in the study said it is being administered in a controlled environment.
“It’s being administered in a very particular manner by people that are quite well trained,” said Jennifer Mitchell, MAPS PBC principal investigator, and a professor at the University of California, San Francisco. “We are not suggesting that anyone try this on their own at home, in their living room.”
Lubecky is finishing his third humanitarian mission to Ukraine after undergoing the treatment.
“Everyone said PTSD can’t be cured,” he said. “I’m living proof that that isn’t true.”
If you or someone you know is in emotional distress or suicidal crisis, call the Suicide & Crisis Lifeline at 988, or 1-800-273-TALK (8255).
Service members, veterans and their friends and family who need help can also call the Military Crisis Line at 800-273-8255 (press 1 for assistance), or text 838255. The Veterans Crisis Line is 800-273-8255.
A man walks past the office enterance of Marion Biotech, a pharmaceutical company in Noida on the outskirts of New Delhi, India, December 29, 2022.
AFP/Getty
New Delhi — The World Health Organization has issued an alert warning against the use of two Indian cough syrups blamed for the deaths of at least 20 children in Uzbekistan. The WHO said the products, manufactured by India’s Marion Biotech, were “substandard” and that the firm had failed to provide guarantees about their “safety and quality.”
The alert issued on Wednesday came after Uzbekistan authorities said last month that at least 20 children died after consuming a syrup made by the company under the brand name Doc-1 Max.
India’s health ministry subsequently suspended production at the company and Uzbekistan banned the import and sale of Doc-1 Max.
The WHO alert said an analysis of the syrup samples by the quality control laboratories of Uzbekistan found “unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.”
Diethylene glycol and ethylene are toxic to humans when consumed and can prove fatal.
“Both of these products may have marketing authorizations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions,” WHO said.
The products were “unsafe and their use, especially in children, may result in serious injury or death,” it said.
Marion Biotech officials could not be reached immediately for comment.
It is the second Indian drugmaker to face a probe by regulators since October, when the WHO linked another firm’s medicines to a spate of child deaths in Gambia.
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
Unlike rapid antigen tests for COVID, the home STD kits on the market require patients to collect their own samples, and then mail them to a lab for analysis. The issue for regulators is whether kits can be reliably adapted for in-home use.
Eric Harkleroad/KHN
The STD epidemic is “out of control,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the U.S., according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, 1 in 5 Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15 to 20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past three years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments — among them state agencies in Alabama, Alaska, and Maryland — have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’s version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells antigen tests for COVID, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to — and often the same as — those used by the labs a doctor’s office uses,” said Dr. Liz Kwo, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, Florida, who prefers to test in the privacy of his home. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Caldera has been testing himself for HIV and other STDs every three months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe four days. For sure, I would recommend it to other people.”
Dr. Leandro Mena, director of the CDC’s Division of STD Prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million to 20 million tests for gonorrhea and chlamydia are performed in the U.S. each year, Mena said. Widespread use of at-home STD testing, he said, could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Gaydos.
But Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing,” Mahn said.
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja, at Johns Hopkins, said the FDA has a history of moving slowly on home testing. The agency spent seven years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, a professor of public health at Rutgers University. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Sure and Brut aerosol deodorant sprays sold nationwide are being recalled due to the presence of benzene, a cancer-causing chemical, according to a notice posted by the Food and Drug Administration.
The recall includes all lot numbers with expiration dates on or before August 2023, TCP Hot Acquisition dba HRB Brands, which markets the products, stated Wednesday in a news release.
Recalled product.
TCP Hot Acquisition LLC
“While benzene is not an ingredient in any of the recalled products, our review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can,” TCP said.
The consumer products company sold its personal care business to HRB Brands in 2021 for $44.7 million in cash.
Classified as a human carcinogen, benzene can be inhaled or absorbed through skin, resulting in cancers including leukemia, as well as life-threatening blood disorders, the recall stated.
Recalled product.
TCP Hot Acquisition LLC
Widely used in manufacturing, benzene is present throughout the environment and can cause cancer with repeated exposure, according to the Centers for Disease Control and Prevention.
Consumers were urged to stop using the recalled products. Those with questions can call (866) 615-0976 or request a refund at www.brutsurerecall2022.com.
Last year, more than half a dozen products were recalled due to benzene, including six brands of Procter & Gamble dry shampoo and conditioner spray products.
Other prior recalls include five sunscreen products by Coppertone, found to contain benzene in late September, while Johnson & Johnson in July recalled five of its sunscreens found to contain benzene. Another expandedrecall involved hand sanitizer sprays found to contain benzene.
