The Food and Drug Administration has issued a warning advising consumers not to purchase or use nitrite “poppers” after an observed increase in reports of deaths and hospitalizations with issues such as severe headaches, dizziness, increase in body temperature, difficulty breathing, extreme drops in blood pressure, blood oxygen issues (methemoglobinemia) and brain death after ingestion or inhalation of nitrite “poppers.”
“‘Poppers,’ which are sold online or at adult novelty stores, may be marketed as nail polish removers but are being ingested or inhaled for recreational use or to enhance sexual experiences. These products contain nitrites, which are chemical substances that should not be ingested or inhaled unless specified/prescribed by a healthcare provider.”
“Brand names include Jungle Juice, Extreme Formula, HardWare, Quick Silver, Super RUSH, Super RUSH Nail Polish Remover and Premium Ironhorse, among others.”
While poppers were banned in Canada in 2013 and nearly banned in the U.K. in 2016, they remain legal in the U.S. The FDA says it will continue tracking reports of adverse events resulting from the ingestion or inhalation of nitrite “poppers” and will take appropriate actions to protect the public health. The agency also has contacted its federal partners alerting them of the recent adverse event reports.
Consumers who have experienced an adverse event (illness or injury) after using nitrite “poppers” should consult their healthcare providers. Consumers should also report their adverse events to MedWatch: FDA’s Safety Information and Adverse Event Reporting Program and information about the products they used to Reporting Unlawful Sales of Medical Products on the Internet | FDA.
Recommendations for Consumers
- Do not purchase or use nitrite “poppers” for recreational use or sexual enhancement.
- Be aware of the serious risks, including death, associated with the use of these products and stop using them immediately. Discard any unused product.
- Contact your healthcare providers immediately if you are experiencing illness after using these products.
- Contact your healthcare providers if you have recently used these products and are concerned about your health.
HIV Preventive Care Is Supposed to Be Free in the US. So, Why Are Some Patients Still Paying?
The Department of Labor issued rules in July clarifying that health plans need to cover the costs of prescription drugs proven to prevent HIV infection, along with related lab tests and medical appointments, at no cost to patients. More than half a year later, the erroneous billing continues.
This article originally appeared in Kaiser Health News.
Anthony Cantu, 31, counsels patients at a San Antonio health clinic about a daily pill shown to prevent HIV infection. Last summer, he started taking the medication himself, an approach called preexposure prophylaxis, better known as PrEP. The regimen requires laboratory tests every three months to ensure the powerful drug does not harm his kidneys and that he remains HIV-free.
But after his insurance company, Blue Cross and Blue Shield of Texas, billed him hundreds of dollars for his PrEP lab test and a related doctor’s visit, Cantu panicked, fearing an avalanche of bills every few months for years to come.
“I work in social services. I’m not rich. I told my doctor I can’t continue with PrEP,” said Cantu, who is gay. “It’s terrifying getting bills that high.”
A national panel of health experts concluded in June 2019 that HIV prevention drugs, shown to lower the risk of infection from sex by more than 90%, are a critical weapon in quelling the AIDS epidemic. Under provisions of the Affordable Care Act, the decision to rate PrEP as an effective preventive service triggered rules requiring health insurers to cover the costs. Insurers were given until January 2021 to adhere to the ruling.
Faced with pushback from the insurance industry, the Department of Labor clarified the rules in July 2021: Medical care associated with a PrEP prescription, including doctor appointments and lab tests, should be covered at no cost to patients.
More than half a year later, that federal prod hasn’t done the trick.
In California, Washington, Texas, Ohio, Georgia, and Florida, HIV advocates and clinic workers say patients are confounded by formularies that obfuscate drug costs and by erroneous bills for ancillary medical services. The costs can be daunting: a monthly supply of PrEP runs $60 for a generic and up to $2,000 for brand-name drugs like Truvada and Descovy. That doesn’t include quarterly lab tests and doctor visits, which can total $15,000 a year.
“Insurers are quite smart, and they have a lot of staff,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. They are setting up “formularies in a way that looks like I’m going to have to pay, and that’s one of the barriers. They are not showing this is free for people in an easy way.”
Schmid has found repeated violations: bewildering drug formularies that wrongly assign copays; PrEP drugs listed in the wrong tier. Some plans offer zero-cost access only to Descovy, a patented drug Gilead Sciences tested only in men and transgender women that is not authorized by the FDA for use by women who have vaginal sex.
More than 700,000 Americans have died from HIV-related illnesses since the AIDS epidemic emerged in 1981. But compared with its devastating impacts in the 1980s and ’90s, HIV is now largely a chronic disease in the U.S., managed with antiretroviral therapy that can suppress the virus to undetectable — and non-transmissible — levels. Public health officials now promote routine testing, condom use, and preexposure prophylaxis to prevent infections.
“Contracting HIV or AIDS is not a fear of mine,” said Dan Waits, a 30-year-old gay man who lives in San Francisco. “I take PrEP as an afterthought. That’s a huge shift from a generation ago.”
Still, 35,000 new infections occur each year in the U.S., according to KFF. Of those, 66% occur through sex between men; 23% through heterosexual sex; and 11% involve injecting illegal drugs. Black people represent nearly 40% of the 1.2 million U.S. residents living with HIV.
HIV prevention drugs, including a long-lasting injectable approved by the FDA last December, are critical to reducing the rate of new infections among high-risk groups. But uptake has been sluggish. An estimated 1.2 million Americans at risk of HIV infection should be taking the pills, according to the Centers for Disease Control and Prevention, but only 25% are doing so, and use among Black and Hispanic patients is especially low.
“Until we can increase uptake of PrEP in these communities, we’re not going to be successful in bringing about an end to the HIV epidemic,” said Justin Smith, director of the Campaign to End AIDS at Positive Impact Health Centers in Atlanta. Among U.S. metropolitan areas, Atlanta has the second-highest rate of new HIV infections, after Miami.
Women remain a neglected group when it comes to PrEP education and treatment. In some urban areas, such as Baltimore, women account for 30% of people living with HIV. But women have been largely ignored by PrEP marketing efforts, said Dr. Rachel Scott, scientific director of women’s health research at the MedStar Health Research Institute in Washington, D.C.
Scott runs a reproductive health clinic that cares for women with HIV and those at risk of infection. She counsels women whose sexual partners do not use condoms or whose partners have HIV and women who have transactional sex or share needles to consider the HIV prevention pill. Most, she said, are completely unaware a pill could help protect them.
In the years since Truvada, the first HIV prevention pill authorized by the FDA, was approved in 2012, lower-priced generic versions have entered the market. While a monthly supply of Truvada can cost $1,800, generic prescriptions are available for $30 to $60 a month.
Even as medication costs have decreased, lab tests and other accompanying services are still being billed, advocates say. Many patients are unaware they do not have to pay out-of-pocket. Adam Roberts, a technology project manager in San Francisco, said his company’s health insurer, Aetna, has charged him $1,200 a year for the past three years for his quarterly lab tests.
“I assumed that was the cost of being on the medication,” said Roberts, who learned about the issue from a friend in January.
Enforcing coverage rules falls to state insurance commissioners and the Department of Labor, which oversees most employer-based health plans. But enforcement is driven largely by patient complaints, said Amy Killelea, an Arlington, Virginia-based lawyer who specializes in HIV policy and coverage.
“It’s the employer-based plans that are problematic right now,” said Killelea, who works with clients to appeal charges with insurers and file complaints with state insurance commissioners. “The current system is not working. There need to be actual penalties for noncompliance.”
A spokesperson for the Department of Labor, Victoria Godinez, said that people who have concerns about their plan’s compliance with the requirements should contact the Department of Labor’s Employee Benefits Security Administration.
Even as they push for broader enforcement, HIV organizations are taking one small victory at a time.
On Feb. 16, Anthony Cantu received a letter from the Texas Department of Insurance informing him that Blue Cross and Blue Shield of Texas had reprocessed his claims for PrEP-related lab costs. The insurance company assured state officials that future claims submitted through Cantu’s plan “will be reviewed to make sure the Affordable Care Act preventive services would not be subject to coinsurance, deductible, copayments, or dollar maximums.”
The news was welcome, said Schmid of the HIV+Hepatitis Policy Institute, but “it shouldn’t have to be so hard.”
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.
One-third of gay and bisexual PrEP users discontinue use within three years
Familiarity and favorable attitudes towards PrEP have increased over time, though use remains low
A new study from the Williams Institute at UCLA School of Law finds a significant increase in familiarity with pre-exposure prophylaxis (PrEP) among gay and bisexual men. The Centers for Disease Control and Prevention (CDC) regards PrEP as a highly effective tool to prevent the transmission of HIV. However, one-third (33%) of gay and bisexual men who were taking PrEP discontinued use over a three-year period.
Using data from the Generations Study, a national probability sample of LGB people in the U.S., researchers explored familiarity, attitudes, uptake, and discontinuation of PrEP among gay and bisexual men from 2016 to 2018. This is the first study to document longitudinal trends in PrEP use in a national probability sample of gay and bisexual men at risk for HIV.
Researchers found that among gay and bisexual men, attitudes toward PrEP were mostly positive, but more than a quarter (27%) of gay and bisexual men who were both eligible for and familiar with PrEP had a negative attitude towards it. While uptake of PrEP increased over the study period, overall use remained persistently low.
“Stigma around the use of PrEP, as well as concerns regarding long-term side effects and conflicting messages from AIDS service providers, may foster confusion around the benefits of taking PrEP,” said study author llan H. Meyer, Ph.D., Distinguished Senior Scholar of Public Policy at the Williams Institute. “Multi-level interventions are needed to improve education, reduce barriers to access, and promote use among gay and bisexual men.”
- PrEP familiarity increased considerably between 2016 and 2018 among those eligible for PrEP from 60% to 92%.
- Favorable attitudes toward PrEP increased more modestly from 68% in 2016 to 73% in 2018.
- PrEP use increased by 90% between 2016 (4%) and 2018 (8%). However, overall use among eligible men remained low.
- Among respondents who reported PrEP use, 33% subsequently discontinued PrEP.
“PrEP uptake has been slow, especially among racial/ethnic minority gay and bisexual men,” said lead author Ian W. Holloway, Associate Professor of Social Welfare at the UCLA Luskin School of Public Affairs. “We’re hopeful that new innovations in PrEP delivery, including on-demand dosing and injectable PrEP, can help expand PrEP coverage with diverse gay and bisexual men in the coming years.”