fda

anti-abortion-group’s-studies-retracted-before-supreme-court-mifepristone-case

Anti-abortion group’s studies retracted before Supreme Court mifepristone case

Abortion, fda, health, mifepristone, retraction, Science, Scientific publishing, Supreme Court / /

retracted —

A large number of other, non-retracted studies find mifepristone to be very safe.

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Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

Enlarge / Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

Scientific journal publisher Sage has retracted key abortion studies cited by anti-abortion groups in a legal case aiming to revoke regulatory approval of the abortion and miscarriage medication, mifepristone—a case that has reached the US Supreme Court, with a hearing scheduled for March 26.

On Monday, Sage announced the retraction of three studies, all published in the journal Health Services Research and Managerial Epidemiology. All three were led by James Studnicki, who works for The Charlotte Lozier Institute, a research arm of Susan B. Anthony Pro-Life America. The publisher said the retractions were based on various problems related to the studies’ methods, analyses, and presentation, as well as undisclosed conflicts of interest.

Two of the studies were cited by anti-abortion groups in their lawsuit against the Food and Drug Administration (Alliance for Hippocratic Medicine v. FDA), which claimed the regulator’s approval and regulation of mifepristone was unlawful. The two studies were also cited by District Judge Matthew Kacsmaryk in Texas, who issued a preliminary injunction last April to revoke the FDA’s 2000 approval of mifepristone. A conservative panel of judges for the 5th Circuit Court of Appeals in New Orleans partially reversed that ruling months later, but the Supreme Court froze the lower court’s order until the appeals process had concluded.

Mifepristone, considered safe and effective by the FDA and medical experts, is used in over half of abortions in the US.

Criticism

Amid the legal dispute, the now-retracted studies drew immediate criticism from experts, who pointed out flaws. Of the three, the most influential and heavily criticized is the 2021 study titled “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015” (PDF). The study suggested that up to 35 percent of women on Medicaid who had a medication abortion between 2001 and 2015 visited an emergency department within 30 days afterward. Its main claim was that medication abortions led to a higher rate of emergency department visits than surgical abortions.

Critics noted a number of problems: The study looked at all emergency department visits, not only visits related to abortion. This could capture medical care beyond abortion-related conditions, because people on Medicaid often lack primary care and resort to going to emergency departments for routine care. When the researchers tried to narrow down the visits to just those related to abortion, they included medical codes that were not related to abortion, such as codes for ectopic pregnancy, and they didn’t capture the seriousness of the condition that prompted the visit. Medication abortions can cause bleeding, and women can go to the emergency department if they don’t know what amount of bleeding is normal. The study also counted multiple visits from the same individual patient as multiple visits, likely inflating the numbers. Last, the study did not put the data in context of emergency department use by Medicaid beneficiaries in general over the time period.

In contrast to Studnicki’s study, the American College of Obstetricians and Gynecologists notes that studies looking at tens of thousands of medication abortions have concluded that “Serious side effects occur in less than 1 percent of patients, and major adverse events—significant infection, blood loss, or hospitalization—occur in less than 0.3 percent of patients. The risk of death is almost non-existent.”

Anti-abortion group’s studies retracted before Supreme Court mifepristone case Read More »

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Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal

aducanumab, Aduhelm, Alzheimer's, Biogen, clinical trial, fda, health, Science / /
Multistory glass office building.

Enlarge / The exterior of the headquarters of biotechnology company Biogen in Cambridge, Massachusetts.

Biotechnology company Biogen is abandoning Aduhelm, its questionable Alzheimer’s drug that has floundered on the market since its scandal-plagued regulatory approval in 2021 and brow-raising pricing.

On Wednesday, the company announced it had terminated its license for Aduhelm (aducanumab) and will stop all development and commercialization activities. The rights to Aduhelm will revert back to the Neurimmune, the Swiss biopharmaceutical company that discovered it.

Biogen will also end the Phase 4 clinical trial, ENVISION, that was required by the Food and Drug Administration to prove Biogen’s claims that Aduhelm is effective at slowing progression of Alzheimer’s in its early stages—something two Phase 3 trials failed to do with certainty.

In the announcement, Biogen noted it took a financial hit of $60 million in the fourth quarter of 2023 to close out its work on Aduhelm, which the company at one point reportedly estimated would bring in as much as $18 billion in revenue per year.

The saga

But the data never appeared to support such lofty aspirations. The drug is intended to work against the clumps of misfolded beta-amyloid protein that accumulate in the brains of people with Alzheimer’s. Though a small, early clinical trial showed the drug could reduce plaques in the brains of people with Alzheimer’s, it initially failed two identically designed Phase 3 trials. The trials, which collectively enrolled nearly 3,300 patients, intended to evaluate if the drug could slow the progression of Alzheimer’s in its early stages.

In March 2019, the company announced that it was ending both trials after a futility analysis indicated that the drug wasn’t working. But later that year, Biogen stunningly reversed course, saying that additional data had rolled in from the trials after the March announcement. A new analysis of the data from one of the two trials indicated that a subset of patients given the highest dose showed a small benefit on cognitive tests—though the patients in the other trial still saw no benefit. The data also found that 40 percent of patients given the high dose developed brain swelling.

Biogen boldly submitted its data to the FDA for approval. In November 2020, a panel of independent advisors for the FDA voted resoundingly against Aduhelm’s approval. Ten of 11 committee members voted against the drug while the remaining member voted “uncertain.” After voting no, one member commented on the “incongruity” of Biogen’s presentation of the drug and the actual data. “It just feels to me like the audio and the video on the TV are out of sync, and there are literally a dozen red threads that suggests concerns about the consistency of evidence—a dozen,” the member said. The FDA, too, in its own statistical analysis of the data, concluded that “there is no compelling substantial evidence of treatment effect or disease slowing.”

Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal Read More »

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COVID shots protect against COVID-related strokes, heart attacks, study finds

65+, adults, blood clot, CDC, COVID-19, fda, health, heart attack, Science, stroke, vaccine / /

stay up to date —

Data provides more evidence older people should stay up to date on COVID vaccines.

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A vial of the updated 2023-2024 formula of Pfizer's COVID-19 vaccine at a CVS Pharmacy in Eagle Rock, California, on September 14, 2023.

Enlarge / A vial of the updated 2023-2024 formula of Pfizer’s COVID-19 vaccine at a CVS Pharmacy in Eagle Rock, California, on September 14, 2023.

Staying up to date on COVID-19 vaccines can cut the risk of COVID-related strokes, blood clots, and heart attacks by around 50 percent in people ages 65 years or older and in those with a condition that makes them more vulnerable to those events, according to a new study from the Centers for Disease Control and Prevention.

The finding, published this week in the CDC’s Morbidity and Mortality Weekly Report, should help ease concerns that the shots may conversely increase the risk of those events—collectively called thromboembolic events. In January 2023, the CDC and the Food and Drug Administration jointly reported a preliminary safety signal from their vaccine-monitoring systems that indicated mRNA COVID-19 vaccines may increase the risk of strokes in the 21 days after vaccination of people ages 65 and older. Since that initial report, that signal decreased, becoming statistically insignificant. Other vaccine monitoring systems, including international systems, have not picked up such a signal. Further studies (summarized here) have not produced clear or consistent data pointing to a link to strokes.

In May, the FDA concluded that the evidence does not support any safety concern and reported that “scientists believe factors other than vaccination might have contributed to the initial finding.”

But, the statistical blip could potentially cause lingering concerns. While clinicians had noted lower rates of thromboembolic events among vaccinated people, the authors of the new study noted that, until now, there were no rigorous estimates of how effective COVID-19 vaccines are at preventing those events.

For their analysis, they primarily looked at two groups of patients: A group of 12.7 million Medicare beneficiaries ages 65 and older and a group of around 78,600 Medicare beneficiaries ages 18 and older with end-stage renal disease (ESRD) on dialysis, a condition that increases their risk for thromboembolic events, including COVID-19-related thromboembolic events. Using medical claims records from September 2022 to March 2023, the researchers compared rates of thromboembolic events among the people in those groups that had gotten a bivalent COVID-19 booster dose and those who had only gotten the original monovalent COVID-19 vaccine in the past. To be considered a COVID-related thromboembolic event, the event had to occur within a week of or a month after a COVID-19 diagnosis.

Protective effect

In the group of 12.7 million patients ages 65 and older, about 5.7 million (45 percent) had gotten the bivalent booster, making them up to date on their COVID-19 vaccinations at the time. The remaining 7 million (55 percent) had only gotten the original vaccine.

During the study period, 17,746 patients who were not up to date on their COVID shots got COVID-19 and experienced a COVID-related thromboembolic event. Of the bivalent boosted patients, there were 4,255 COVID-related thromboembolic events. The researchers adjusted for confounding factors, such as age, race, and time of vaccination, and estimated that the bivalent booster was overall 47 percent effective at preventing COVID-related thromboembolic events, which again include strokes, blood clots, and heart attacks.

A sub-analysis including the time since vaccination indicated that the estimated effectiveness waned about two months after receipt of the vaccine, dropping early effectiveness of 54 percent down to 42 percent at 60 days or more.

Among the 78,600 patients ages 18 and up with ESRD, 23,229 (29.5 percent) received a bivalent dose and thus were up to date on their COVID-19 vaccines. The remaining patients (70.5 percent) had only received an original vaccine, and of those, 917 experienced a COVID-19-related thromboembolic event after getting the pandemic virus. Among the up-to-date patients, there were only 123 events. After adjustments, the researchers estimated that the vaccines’ effectiveness against thromboembolic events was 51 percent in this group, which also waned slightly over time.

The study has limitations, such as that it can’t account for previous COVID-19 infections, which could alter people’s risk of developing complications from COVID-19, including thromboembolic events. It relied on medical claims, which have limitations, and it’s possible there are other confounding factors, such as the use of Paxlovid and behavioral differences. Last, Medicare beneficiaries are not representative of the whole population.

But, given the data available, the study authors concluded that it appears the bivalent vaccine dose “helped provide protection against COVID-19–related thromboembolic events compared with more distant receipt of original monovalent doses alone.” The authors recommend that, “to prevent COVID-19–related complications, including thromboembolic events, adults should stay up to date with recommended COVID-19 vaccination.”

The CDC currently estimates that only 21 percent of adults ages 18 and up have received the latest COVID-19 booster dose, including 41.5 percent of adults ages 65 and up.

COVID shots protect against COVID-related strokes, heart attacks, study finds Read More »

chromium-found-in-lead-tainted-fruit-pouches-may-explain-contamination

Chromium found in lead-tainted fruit pouches may explain contamination

adulteration, CDC, children, chromium, cinnamon, cinnamon applesauce, contamination, fda, fruit pouches, health, lead, lead chromate, lead poisoning, Science, spices, WanaBana / /

Nightmare —

Lead chromate, an artificial coloring, has been used in other spices to conceal poor quality.

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The three recalled pouches linked to lead poisonings.

Enlarge / The three recalled pouches linked to lead poisonings.

The Food and Drug Administration has discovered a second metal contaminant—chromium—in the recalled cinnamon applesauce pouches found to contain cinnamon contaminated with extremely high levels of lead. The products have now poisoned nearly 300 young children in 37 states.

The health implications of the additional contaminant are not clear. There is no antidote for chromium exposure, and the Centers for Disease Control and Prevention recommends supportive care. But the finding does hint at the possible motivation behind the tragic poisonings.

In the FDA’s announcement, the agency noted that “The lead-to-chromium ratio in the cinnamon apple puree sample is consistent with that of lead chromate (PbCrO4).” This is a notorious adulterant of spices used to artificially bolster their color and weight.

Lead chromate is a vibrant yellow substance that has frequently turned up in turmeric sourced from India and Bangladesh. In a 2017 study by public health researchers at Boston University, 16 of 32 turmeric products bought in markets in the Boston area had lead levels over the FDA’s allowable lead level for candy (the FDA does not have guidelines for lead levels in spices, specifically). Two samples, the only two samples sourced from Bangladesh, exceeded the allowable lead level by two orders of magnitude. The researchers had conducted the study after a string of lead poisoning cases in US children were linked to contaminated spices, including turmeric. Other studies have also identified spices as a source of lead exposure in US children.

The 2017 study highlighted the reason that lead chromate is used as an adulterant. A media outlet in Bangladesh quoted one turmeric trader’s explanation: “Traders use the artificial color [lead chromate] to hide the marks of pest attacks and other spots on raw turmeric. It is used during boiling and polishing to make the spice look brighter to attract big buyers, including spice processing firms.”

The FDA’s testing does not definitively conclude that lead chromate was in the contaminated cinnamon, which was sourced from an Austrofoods manufacturing facility in Ecuador and used in the recalled applesauce pouches. But it does bolster the FDA’s suspicion that the poisonings were the result of “economically motivated adulteration,” a specific category of food fraud defined by the FDA.

Jim Jones, FDA’s deputy commissioner for human foods, told Politico in December that the agency believed then that the contamination was economically motivated. “My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.”

Health effects

For the hundreds of US children poisoned by the applesauce pouches, the finding of chromium adds yet more nightmarish uncertainty of possible long-term health effects. Lead is a potent neurotoxic metal that can damage the brain and nervous system. In developing toddlers and younger children, the effects of the acute exposures could manifest as learning and behavior problems, as well as hearing and speech problems in the years to come.

The effects of chromium exposure are less clear. Chromium is a naturally occurring metal and an essential trace nutrient. But there are two notable forms: chromium III and the more toxic chromium VI. The FDA’s testing couldn’t identify which form of chromium was present in the cinnamon applesauce pouches, but the more toxic chromium VI is what’s present in lead chromate. Chromium VI is considered a carcinogen, and chronic, prolonged inhalation and skin exposure is associated with chronic lung disease and ulceration of skin and mucous membranes, the CDC notes. But the effects of eating chromium VI are not well studied or understood beyond the immediate, nonspecific effects of an acute exposure—which might include abdominal pain, nausea, vomiting, diarrhea, anemia, and kidney and liver dysfunction.

The CDC and the FDA note that it’s possible that even if chromium VI contaminated the applesauce pouches, the acidity of the applesauce and the stomach may have converted the chromium VI to chromium III.

The FDA recommends that the families of children exposed to the recalled pouches—especially those with elevated blood lead levels—should inform their health care providers of potential chromium exposure. The CDC provided clinical guidance for doctors on how to test and care for children with exposure.

The recalled cinnamon applesauce pouches include WanaBana apple cinnamon fruit puree pouches (sold nationally and through multiple retailers, including Amazon and Dollar Tree), Schnucks-brand cinnamon-flavored applesauce pouches and variety packs (sold at Schnucks and Eatwell Markets grocery stores), and Weis-brand cinnamon applesauce pouches (sold at Weis grocery stores).

According to the CDC’s latest numbers, which, as of the time of publication, were last updated on December 29, there have been a total of 287 cases identified across 37 states.

Chromium found in lead-tainted fruit pouches may explain contamination Read More »

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FDA would like to stop finding Viagra in supplements sold on Amazon

Amazon, cialis, drugs, fda, health, Policy, supplements, Viagra / /

Well, that’s one kind of energy —

“Big Guys Male Energy Supplement” turns out to be a vehicle for prescription drugs.

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Image of a pile of blue pills that forms the shape of a male symbol.

If you were to search for a product called “Mens Maximum Energy Supplement” on Amazon, you’d be bombarded with everything from caffeine pills to amino acid supplements to the latest herb craze. But at some point last year, the FDA had purchased a specific product by that name from Amazon and sent it off to one of its labs to find out if the self-proclaimed “dietary supplement” contained anything that would actually boost energy.

In August, the FDA announced that the supposed supplement was actually a vehicle for a prescription drug that offered a very specific type of energy boost. It contained sildenafil, a drug much better known by its brand name: Viagra.

Four months later, the FDA is finally getting around to issuing a warning letter to Amazon, giving it 15 days to not only address Mens Maximum Energy Supplement and a handful of similar vehicles for prescription erection boosters, but also asking for an explanation of how the company is going to keep similarly mislabelled prescription drugs from being hawked on its site in the future.

Prescription energy

Mens Maximum Energy Supplement was just one of seven products that the FDA found for sale on Amazon that contained either Sildenafil or Tadalafil (marketed as Cialis). The product names ranged from the jokey (WeFun and Genergy) to the vaguely suggestive (Round 2) to the verbose (Big Guys Male Energy Supplement and X Max Triple Shot Energy Honey). All of them were marketed as supplements and contained no indication of their active ingredients.

And that, as the FDA explains to Amazon in detail, means selling those products violates a whole host of laws and regulations. They’re being marketed as dietary supplements, but don’t fit the operative legal definition of these supplements. They’re offering prescription drugs without providing directions for their intended and safe use. They contain no warnings about unsafe doses or how long they can be used safely.

The FDA points out that these rules exist for very good reasons. Both of the drugs found in these supplements inhibit an enzyme called a type-5 phosphodiesterase which, among other things, influences the circulatory system. One potential side effect is a dangerous drop in blood pressure. Both Sildenafil and Tadalafil can also have dangerous interactions with a specific class of drugs often taken by those with diabetes, high blood pressure, or heart disease.

Legal remedies

The FDA’s letter makes it clear that the highlighted supplements aren’t intended to be an exhaustive list of the products that Amazon offers in violation of federal law. And it is very explicit about the fact that it is Amazon’s responsibility (and not the FDA’s) to ensure compliance: “You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.”

And Amazon clearly has its work cut out for it. None of the products cited by the FDA’s letter appear to still be for sale under the same name at Amazon—a company spokesperson told Ars that it pulled them in response to the original FDA findings. But searches for them at Amazon brought up a number of similar products, many of which included pills with the blue color that Viagra was marketed with.

So, the FDA wants to see a plan that describes how Amazon will not only deal with the products at issue in this letter, but prevent all similar violations in the future: “Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon will no longer introduce or deliver for introduction into interstate commerce unapproved new drugs and/or misbranded products with undeclared drug ingredients, as well as copies of related documentation.”

Amazon is being given 15 days to respond to the warning letter. Failure to adequately address these violations, the FDA warns, will result in legal action.

FDA would like to stop finding Viagra in supplements sold on Amazon Read More »

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MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy

fda, health, maps, mdma, psychedelics, PTSD, Science, therapy / /

Groovy —

If FDA approved, it would require the DEA to reclassify MDMA.

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Girl with an ecstasy tablet on her tongue.

Enlarge / Girl with an ecstasy tablet on her tongue.

A corporation dedicated to studying the benefits of psychedelic drugs filed an application with the Food and Drug Administration this week for approval to use MDMA—aka ecstasy or molly—in combination with talk therapy to treat post-traumatic stress disorder.

If approved, it would be the first-of-its-kind combination treatment—a psychedelic-assisted therapy. An approval would also require the Drug Enforcement Administration to reclassify MDMA, which is currently in the DEA’s most restricted category, Schedule I, which is defined as drugs “with no currently accepted medical use and a high potential for abuse.” The category also includes LSD, heroin, and marijuana.

The public benefit corporation (PBC) that filed the FDA application was created by MAPS, The Multidisciplinary Association for Psychedelic Studies, which has been supporting this type of work since 1986. The application is based on positive data from two randomized, double-blind, placebo-controlled Phase III studies, which were funded and organized by MAPS and MAPS PBC.

The first study, published in Nature Medicine in 2021, involved a total of 90 participants with moderate PTSD. It found that MDMA-assisted talk therapy (aka psychotherapy) significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given talk therapy with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

In both trials, participants took 80 to 180 mg doses of MDMA or a placebo at the start of three eight-hour sessions, which were spaced around a month apart. Between those experimental treatment sessions, participants also had three 90-minute sessions for participants to process the experimental experience.

MDMA—3,4-methylenedioxymethamphetamine—affects neurotransmitters in the brain, increasing the activity of serotonin, dopamine, and norepinephrine, to be specific. This leads people who take the drug to experience euphoria, hallucinations, sharpened sensory perception, and sociability, but it can also induce confusion, depression, and paranoia. Its use in psychotherapy has been explored for decades.

In a statement this week, MAPS PBC CEO Amy Emerson celebrated the FDA submission. “The filing of our [new drug application] is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” she said.

MAPS founder and President Rick Doblin also celebrated the submission this week, saying in a statement: “When I started MAPS in 1986, the FDA was still blocking all research with psychedelics. … By breaking that barrier, we have opened doors for others to conduct their own promising research into psychedelic-assisted therapies with psilocybin, ayahuasca, ketamine, and more. The novel approaches undertaken in psychedelic-assisted therapy research have led to fundamental shifts in our understanding of how these devastating mental health conditions can be treated.”

So far, the MDMA-assisted therapy has drawn criticism for its expected inaccessibility. The treatment outlined in the two MDMA trials involves lengthy—and likely pricey—therapy sessions with highly trained therapists. The Washington Post published an estimated price of between $13,000 to $15,000 per treatment round, and it’s unclear for now whether it would be covered by health insurance if approved by the FDA. “Most people in the world won’t be able to afford these clinics,” Allen Frances, a Duke University professor emeritus of psychiatry, told the Post.

Now that the NDA is submitted, the FDA has 60 days to determine whether it will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively), MAPS PBS noted. MAPS is seeking a priority review. In 2017, the FDA granted MDMA “Breakthrough Therapy,” designed to help hasten the development and review of drugs for serious conditions when evidence indicates they may substantially improve upon current therapies.

The only psychedelic with FDA approval to date is esketamine, a variation of ketamine, which was approved in 2019 to treat treatment-resistant depression.

MDMA—aka ecstasy—submitted to FDA as part of PTSD therapy Read More »

every-homeopathic-eye-drop-should-be-pulled-off-the-market,-fda-says

Every homeopathic eye drop should be pulled off the market, FDA says

eye drops, fda, health, homeopathic, infection, Science, Vision / /

don’t risk it —

Eye drops are uniquely risky because the eye is an immune-privileged site.

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Young man applying eye drops.

This year has been marked by many terrifying things, but perhaps the most surprising of the 2023 horrors was … eye drops.

The seemingly innocuous teeny squeeze bottle made for alarming headlines numerous times during our current revolution around the sun, with lengthy lists of recalls, startling factory inspections, and ghastly reports of people developing near-untreatable bacterial infections, losing their eyes and vision, and dying.

Recapping this unexpected threat to health, the Food and Drug Administration on Tuesday released an advisory titled “What You Should Know about Eye Drops” in hopes of keeping the dangers of this year from leaking into the next. Among the notable points from the regulator was this stark pronouncement: No one should ever use any homeopathic ophthalmic products, and every single such product should be pulled off the market.

The point is unexpected, given that none of the high-profile infections and recalls this year involved homeopathic products. But, it should be welcomed by any advocates of evidence-based medicine.

Homeopathy is an 18th century pseudoscience that produces bogus remedies that work no better than a placebo and, if prepared improperly, can be toxic, even deadly. The practice relies on two false principles: the  “law of similars,” aka “like cures like,” meaning a substance that causes a specific symptom in a healthy person can treat conditions and diseases that involve that same symptom, and the “law of infinitesimals,” which states that diluting the substance renders it more potent. As such, homeopathic products begin with toxic substances that are then extremely diluted—often into oblivion—in a ritualistic procedure. Some homeopaths hold that water molecules can have “memory.”

Clear risks

In the US, these products are marketed as legitimate treatments and sold alongside evidence-based treatments (though consumer advocates are trying to change that). The reason this is allowed for now is because of a regulatory quirk: Based on the 1938 Food, Drug, and Cosmetic Act, homeopathic products are generally considered exempt from pre-market FDA safety and efficacy reviews as long as the active ingredient in the product is included in the Homeopathic Pharmacopoeia, a list of substances approved by homeopaths.

In recent years, the FDA and the Federal Trade Commission have cracked down on homeopathic products, though. And it seems from today’s advisory that the FDA is not holding back on homeopathic products for the eyes. The regulator notes that any products meant for the eye “pose a heightened risk of harm” because the eyes are an immune-privileged site in the body. That is, innate immune responses are restrained in the eye to prevent damaging inflammation, which could threaten vision. “Any drug used in the eyes must be sterile to reduce the risk of infection,” the FDA said.

But whether or not homeopathic eye drops are labeled as sterile doesn’t seem to matter to the FDA. The regulator cautions: “Do not use ophthalmic products that: Are labeled as homeopathic, as these products should not be marketed.” Their lack of pre-market safety and efficacy reviews appears to be enough to warrant avoidance.

The FDA also cautions consumers not to use any over-the-counter eye drop product that claims to treat glaucoma, cataracts, retinopathy, or macular degeneration because there are simply no actual over-the-actual treatments for these conditions. If a non-prescription product claims this, you can assume it’s bogus and avoid it. Consumers should also avoid anything that includes Methylsulfonylmethane (MSM), which is illegally sold in the US, and anything with silver sulfate or argentum because these can permanently change the white color of your eyes.

Every homeopathic eye drop should be pulled off the market, FDA says Read More »