Posts tagged with "FDA"

2020 hindsight: LASIK eye surgery should be taken off market, former FDA adviser says

November 15, 2019

Don’t turn a blind eye to the risks involved in LASIK eye surgery, an expert is warning, according to CBS News.

Laser vision correction has been popular for more than 20 years, with an estimated 20 million Americans undergoing the procedure to correct nearsightedness and improve distance vision.

According to an FDA patient survey, more than 95% of patients have been satisfied with their vision after surgery. But some patients say the surgery has ruined their eyesight. Among the complaints: “relentless eye pain,” dizziness, and detached retinas.

“Essentially we ignored the data on vision distortions that persisted for years,” said Morris Waxler— a retired FDA adviser who is now president of Waxler Regulatory Consulting. He voted to approve LASIK devices, but he now says voted to approve LASIK, but he now says that vote was a mistake.

“I re-examined the documentation … and I said, ‘Wow this is not good,'” Waxler told CBS News.

Waxler said his own analysis of industry data shows complication rates between 10%  and 30%. In 2011, he petitioned the FDA to issue a voluntary recall of LASIK. Three years later, the agency denied that request and now tells CBS News it “has not found any new safety concerns associated with LASIK devices.” 

Waxler said he thinks LASIK should “absolutely” be taken off the market. “There’s nothing wrong with a person’s eyes who goes to get Lasik,” he said. “They have healthy eyes. They could go and get a pair of glasses.”

Patient Abraham Rutner agrees, alleging that  LASIK surgery damaged his vision and nearly ruined his life. “It’s a devastation that I can’t even explain,” Rutner told CBS News medical contributor Dr. Tara Narula.

“Things would appear double. Around the lights were like having starbursts,” he added.

After months of not being able to drive or do his job, the Brooklyn electrician finally found help in Miami where optometrist Edward Boshnick fitted him with special contact lenses.

“His cornea is very distorted as a result of his LASIK surgery,” Boshnick told CBS.

Boshnick estimates he’s treated thousands of patients with LASIK complications.

Paula Cofer had surgery 19 years ago, “and from day one my vision was an absolute train wreck and it still is today,” she said.

She started a LASIK complications support group on Facebook and quickly found she was not alone. “You really have to understand you’re risking your only pair of eyes,” Cofer said.

Doctors who perform LASIK surgery said risks can be minimized with pre-surgical screening.

“The most important thing is knowing who to operate on and who not to operate on and there are people who really should not have this procedure,” Dr. Jules Winokur said.

Rutner now believes he was never a good candidate.

Here are FDA’s advisory on risks and how to find the right doctor for the procedure.

Research contact: @CBSNews

Study calculates links between prescription medications and risk for suicide

November 6, 2019

There’s a saying that what doesn’t kill us makes us stronger—but that shouldn’t be true of the FDA-approved drugs prescribed to us by our doctors.

Nevertheless, a review by the Center for Health Statistics at the University of Chicago of 922 medications that had been prescribed to nearly 150 million Americans over an 11-year period recently found that just 10 of these drugs were associated with an increased rate of suicide attempts, the university reported on November 5 in a press release.

Conversely, 44 drugs were linked to a decrease in suicide attempts, including many that carry a “black box” label from the FDA warning of their association with suicidal behavior.

The study findings, published in the Harvard Data Science Review, identifiy several drugs with the potential to prevent suicide attempts that are not currently used for that purpose, including folic acid, a simple vitamin often prescribed to pregnant women.

“There’s an antihistamine that’s associated with decreases in suicide. There’s a Parkinson’s drug associated with decreases,” said Robert Gibbons, PhD, the director of the center and lead author of the study. “If those test out in clinical trials to be real effects, we could be using more of these drugs to treat suicidal people.”

Suicide is now the tenth leading cause of death in the United States, according to the National Institute of Mental Health. Most suicides occur in patients with a psychiatric disorder, such as depression. However, common antidepressant medications such as fluoxetine (Prozac) carry the FDA’s black box warnin— which has led to decreased use of these medications, despite the benefits they might provide.

For the new study, Gibbons and his team developed a statistical tool to measure the links between drugs and suicide attempts. They analyzed data on 922 drugs with more than 3,000 prescriptions in a database of medical claims from 2003 to 2014. The data contained records of 146 million unique patients from more than 100 health insurers in the United States. For each person taking each drug, they counted suicide attempts in the three months prior to filling the prescription and the three months after taking the drug. This approach allowed them to evaluate each drug individually within a single person and see its effect on suicide attempts.

“It’s actually a very simple model that answers the question, ‘Does a suicide attempt occur more frequently after taking the drug than before?'” Gibbons said.=

That analysis found 10 drugs that showed a statistically significant increase in suicide attempts-among them, the opioid painkiller hydrocodone bitartrate and acetaminophen (Vicodin); anti-anxiety drugs alprazolam (Xanax) and diazepam (Valium); and prednisone, a corticosteroid.

 A total of 44 drugs showed a decrease in suicide risk, including a large group of antidepressants with black box warnings like fluoxetine and escitalopram (Lexapro), gabapentin (Neurontin), an anti-convulsant used to treat seizures, and, interestingly, the vitamin folic acid.

Gibbons said the statistical model can be used to calculate the risk of any adverse events that happen before and after taking a medication. The Veterans Administration already has expressed interest in using the tool, and Gibbons hopes other large hospital systems and local health agencies will adopt it to help decide which drugs to prescribe, especially for patients at risk of suicide.

“What we’ve done is come up with an alternative approach to drug safety surveillance that could be used by any agency, country or formulary,” he said. ”

Research contact: @UChicago

FDA proposes that manufacturers and doctors warn women about risks of breast implants

October 24, 2019

Women considering surgery to receive breast implants should be warned in advance of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration (FDA) said on October 23, according to a report by The New York Times.

Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, the Times said, and to provide a checklist spelling out the risks for prospective patients to review before making a decision and putting down a deposit on the surgery.

The measures are not mandated by the agency; they are proposals now open to public comment and industry input.

Millions of women have implants—silicone sacks filled with either saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomies for breast cancer.

Breast augmentation with implants is the most popular cosmetic surgical procedure, the news outlet notes: Some 313,000 augmentations were performed in 2018, a 4% increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.

In turn, thousands of women with implants have reported developing debilitating illnesses, such as severe muscle and joint pain, weakness, cognitive difficulties and fatigue, a constellation of symptoms some experts call “breast implant illness.”

Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune diseases. Implants have also been linked to a rare cancer of the immune system called anaplastic large cell lymphoma, which can be fatal. Most of the cancer cases developed in women with textured implants.

The agency warned two implant manufacturers earlier this year that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.

At an advisory panel meeting in March, women with breast implants testified about their illnesses and implored the agency to take action. More than 70,000 women signed a petition demanding the F.D.A. to require the checklist.

Advocates urged agency officials to require the long-term safety studies that were promised and to start patient registries to track outcomes. Some women asked the F.D.A. to ban breast implants altogether.

According to the Times report, agency officials said they had “heard loud and clear” that there was “a distinct opportunity to do more to protect women who are considering implants.”

The F.D.A. also wants implant manufacturers to list the ingredients in implants, in an easy-to-understand format for patients, so that women know about chemicals and heavy metals in the products.

The agency also is proposing new screening recommendations for women who already have silicone gel implants, saying they should undergo imaging scans to look for ruptures beginning five to six years after the surgery and every two years after that, the Times reported.

At the request of the F.D.A., Allergan in July recalled textured breast implants linked to the unusual cancer.

 Research contact: @nytimes

Biogen’s Alzheimer’s treatment could be ‘the biggest drug ever’

October 23, 2019

Shares of Biogen soared 30% on Tuesday, October 22, CNBC reported, after the drugmaker announced it was seeking regulatory approval for the Alzheimer’s drug, Aducanumab, which it had announced it was at least temporarily giving up on earlier this year.

“It would be the biggest drug ever,” said CNBC’s Jim Cramer on “Squawk on the Street.”

The announcement  from Cambridge, Massachusetts-based Biogen and Tokyo-based Eisai—a leading global research and development-based pharmaceutical company—came after a consultation with the U.S. Food and Drug Administration (FDA) on plans to pursue a regulatory approval for the drug after a Phase 3 EMERGE Study met its primary endpoint—showing a significant reduction in clinical decline.

According to the joint research teams, ‘Patients who received Aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. Patients also experienced benefits on activities of daily living—including conducting personal finances; performing household chores, such as cleaning, shopping, and doing laundry; and independently traveling out of the home.

They noted, “If approved, Aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.”

Indeed, Biogen erased its entire 25% year-to-date decline after the announcement became public. The company plans to file for approval with the FDA in early 2020.

“The whole concept of senior living will change,” commented CNBC’s Cramer. “You know whose going to take this drug?” asked Cramer. “Everyone.”

Research contact: @CNBC

Neutrogena recalls Light Therapy Acne Masks, due to risk of eye injuries

July 22, 2019

Many consumers have “seen the light” when it comes to over-the counter acne LED-light therapy masks—and that’s not necessarily a good thing. In fact, earlier this month, Neutrogena issued a recall of its masks, according to The New York Times;  citing a “theoretical risk of eye injury” to a subset of users who have underlying eye conditions or are taking medicine that makes them sensitive to light.

The Times reported that Neutrogena said in a statement that its July 5 recall followed “reports of mild, transient visual adverse events, combined with a growing scientific discussion around the safety of blue light.”

A spokesperson told the news outlet that the “adverse events” had been caused by the Neutrogena masks; although she did not specify how many such events had taken place. She also said that no particular study or expert had informed the company’s decision to recall the masks.

But that is not the only brand that uses visible blue and red lights to treat facial acne. And it may not be the only mask that is causing problems—problems which the Australian Department of Health recently said could cause retinal damage or impair peripheral vision after repeated therapy with the lights.

Among the most popular among these devices are the Lacomri 7 Color LED Light Therapy Acne Mask, Convinsimo Light Therapy Acne Face Treatment, Neutrogena Light Therapy Acne Mask, and Pulsaderm Acne Clearing Mask.

They all use the same treatment technology, explains the American Academy of Dermatology.

And that also may mean that they might share another problem: Such devices kill facial bacteria that could turn into pimples; they are not effective against existing blackhead, whiteheads, acne cysts, or nodules, the academy explains.

Indeed, says the academy, “Most people see clearing, but not 100%”—and “results vary from person to person.”

News of the recalls in the United States and in Australia was for the most part missed by consumers . A spokesperson for the U.S. Food and Drug Administration told the Times that the agency was “aware of the recall” and was looking into it.

The mask was released by Neutrogena in October 2016. Actress Lena Dunham endorsed it on Instagram and said her post was not an advertisement. The product was awarded Best of Beauty in 2017 by Allure magazine..)

Dr. Rachel Nazarian, with Schweiger Dermatology Group in New York City, told the news outlet that only recently had concerns about blue light cropped up, and that they mostly referred to people who had baseline medical conditions that caused their retinas to be more sensitive to light.

But she said that Neutrogena’s mask did not offer enough eye protection. While she planned to continue to use LED treatments in her own practice, she said she used much stronger eyewear than was provided by the company.

“It shouldn’t be used in such a cavalier form,” Dr. Nazarian said. “If you’re using the right eyewear protection, you should be fine.”

Research contact: @nytimes

Last licks: Woman caught on social media licking store ice cream and putting it back faces years in jail

July 8, 2019

A woman who licked more than her lips at a Walmart store may find herself in the “cooler” soon. The “mystery shopper” (who has not yet been identified by authorities) went viral on social media recently for licking a tub of ice cream and returning it to the frozen food display.

Now police say that, when they find her, she faces up to 20 years in prison for the prank, according to a July 4 report by NBC News.

The footage of the escapade—which already has been viewed more than 11 million times— shows the so-far unnamed woman opening a container, running her tongue across the ice cream; then laughing as she places the violated dessert back in the freezer, in a branch of Walmart in the city of Lufkin, eastern Texas.

She could face a second-degree felony charge of tampering with a consumer product, the Lufkin, Texas, Police Department said in an email statement to NBC News. The charge comes with a two- to 20-year prison term and up to $10,000 in fines, according to Texas state penal code.

Police also want to speak to the man she was with, who is thought to have filmed the incident and can be heard encouraging the woman to “Lick it, lick it.”

According to NBC, investigators also are in discussions with the FDA and additional federal charges could be made.

“Our detectives are working to verify the identity of the female suspect before a warrant is issued for her arrest on a charge of second-degree felony tampering with a consumer product,” a police spokesperson said.

“As that portion of the investigation continues, detectives are focusing on identifying the male (in the green shirt) behind the camera seen in images of the two entering the store together.”

Blue Bell Creameries, the local manufacturer of the ice cream brand the woman licked, has called the incident a “malicious act of food tampering.”

All tubs containing the mix of creamy vanilla ice cream with swirls of chocolate fudge and dark-chocolate-covered roasted peanuts have been removed from the store’s shelves as a precaution, the company said. The specific carton believed to be compromised was found among the lot.

In an earlier statement, the company explained that its cartons are frozen upside down in production, which creates a natural, tight seal by freezing the lid to the tub, meaning consumers would notice if any tampering occurred upon opening a fresh tub.

Research contact: @NBCNews

FDA approves another ‘Viagra for women’

July 3, 2019

Late in June, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide)—a libido-booster for premenopausal women.

The drug is injectable, and the manufacturer—Waltham, Massachusetts-based AMAG Pharmaceuticals—says it should be self-administered by placing the needle under the skin of the adbdomen or thigh and pushing the plunger, at least 45 minutes before sexual activity.

But, the pharmaceutical company also advises that patients, themselves, should decide on the “optimal time” ahead of intercourse for the injection because the drug has side effects that can ruin the mood—among them, nausea and vomiting, flushing, injection site reactions, and headaches.

About 40% of patients in the clinical trials experienced nausea, most commonly with the first Vyleesi injection; and 13% needed medications for the treatment of nausea. About 1% of patients treated with Vyleesi in the clinical trials reported darkening of the gums and parts of the skin, including the face and breasts—which did not go away in about half the patients after stopping treatment. Patients with dark skin were more likely to develop this side effect.

How does it work? Vyleesi activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown.

Still, the FDA says that this drug represents an advance in treating low sexual desire, for women and their partners affected by this problem.

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment. Today’s approval provides women with another treatment option for this condition,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive, and Urologic Products.

The approval of Vyleesi by the FDA follows the agency’s 2015 approval of Addyi, which also was designed to boost libido, but which no one really wanted. (Its sales are currently “tepid,” according to a recent report by The New York Times. Addyi also caused fainting when combined with alcohol.)

Research contact: @US_FDA

Report: Brain health supplements are ‘a massive waste of money’

June 12, 2019

Most of us have seen the TV ads for Prevagen and have heard about the protective effects of ginkgo biloba—and those are just a couple of the dietary aids that Americans swallow in the hope and belief that they will make our brains stronger.

In fact, more than one-quarter (26%) of U.S. adults age 50 and older are taking at least one brain-health supplement, according to the findings of the  2019 AARP Brain Health and Dietary Supplements Survey

And research by the Nutrition Business Journal indicates that fully 69% of U.S. adults age 50 and older are taking a dietary supplement at least three times a week—with 8% saying they’re taking one to “reverse dementia.”

But now we are hearing that those supplements are “a massive waste of money”—and that warning comes from people who should know these things: On June 11, the Global Counsel on Brain Health (GCBH) in partnership with AARP released a report concluding that dietary supplements do not improve brain health or prevent cognitive decline, dementia, or Alzheimer’s disease.

Dietary supplements are not regulated by the FDA, yet 49% of older adults believe otherwise, Prevention magazine reports.

“The GCBH reviewed the scientific evidence on various supplements and determined it could not endorse any ingredient, production, or formulation designed for brain health,” the AARP said in a press release.

Under FDA law, it’s illegal for dietary supplement companies to make any claim that their product can treat, prevent, or cure a disease. If a supplement marketer wants to say their product can reduce the risk of a disease, they must notify the FDA first and get authorization before such a claim can go on a product label, Prevention notes.

Yet, the companies continue to market using misleading claims—among those currently in print or on-air:

  • Clinically shown to be safe and support memory and brain function
  • Clinically proven natural ingredients
  • Supports neurotransmitter development to promote a feeling of mental sharpness
  • Helps your brain maintain healthy neurons to support learning and recall
  • 13 scientifically proven nutrients for a healthier brain
  • Keeps your mind sharp and memory strong
  • Has shown statistically significant improvements in memory and recall in as little as four weeks when taken as directed
  • Designed to help improve memory while increasing focus and concentration
  • Comprehensive blend of vitamins, amino acids, and herbal extracts that support the brain’s structure and function to deliver amazing improvements in memory and concentration!
  • Help lessen the frequency of episodes of forgetfulness and brain fog
  • Improve your ability to retain and recall various kinds of information
  • For cognitive health, memory improvement, memory enhancement
  • These key nutrients have a powerful effect at reducing the inflammatory fires that destroy our brain tissue.

In addition, because dietary supplement companies aren’t regulated by the FDA, neither are their ingredients or dosages. The report warns that supplements “may have too much, too little, or, in some cases, none of the ingredients [consumers] think they’re buying.”

This can have dire consequences. The AARP cites a 2013 report from the U.S. government which found that the FDA received more than 6,000 reports of health problems due to dietary supplements between 2008 and 2011. They included 92 deaths and more than 1,000 series injuries. As part of the FDA’s investigation, the agency’s researchers found “dangerous fungi, pesticides, environmental pollutants, and heavy metals in some products.”

Worse yet, the FDA found that more than 700 dietary supplements contained prescription drugs, including steroids and antidepressants.

“It’s tempting to think you can pop a pill and prevent dementia, but the science says that doesn’t work,” Sarah Lenz Lock, AARP SVP for Policy and Executive Director of the GCBH told Prevention. “We know what will keep your brain healthy: exercise, a healthy diet, plenty of sleep, challenging your thinking skills, and connecting with others.”

Research contact: @AARP

A new way to ‘head off’ allergy symptoms: Immunotherapy is seen as breakthrough treatment

April 12, 2019

If you are one of the 50 million people in America who suffers from seasonal allergies, you probably don’t need anybody to tell you that pollen season is here. You have been sneezing and sniffling and scratching for weeks. But what you might want to hear about is a new immunotherapy treatment in the form of a tablet that has been identified as a promising alternative to over-the-counter medicines and injections.

According to an April 11 report by ABC-TV’s Good Morning America, the new immunotherapy treatment is seen by many professionals as a breakthrough in allergy treatment. A survey by the American College of Allergy, Asthma and Immunology has revealed that 73% of allergists are now offering these tablets as an effective at-home regimen.

There are typically a couple of ways in which allergy sufferers can “head off” their symptoms, according to ABC News’ Chief Medical Correspondent Dr. Jennifer Ashton—either by controlling their environment (reducing the allergens that cause symptoms) or by trying medications that will block allergic responses.

In comparison to these short-term solutions, the new tablets change the immune system’s response to allergens. Patients take increasing doses of the allergens to help build up tolerance.

Indeed, the new tablet immunotherapy could be a good option for those who are already taking the immunotherapy shots, as they offer similar benefits in the form of relieving symptoms, according to Ashton.

The biggest difference between the two is that you can administer the tablets at home rather than having to go to the doctor’s office, although tablets are medication that needs to be prescribed by a doctor.

The only bad news is that, while allergy tablets do not require repeated visits to a doctor’s office, they do require strict compliance and may require up to three years of use to work.

The tablets also cannot be used by all patients, including those with severe or uncontrolled asthma. Additionally, the tablets will only take care of individual allergens, so you would need to take one tablet for each allergen that you react to. By comparison, shots are capable of taking care of multiple allergens at once.

The Food and Drug Administration (FDA) has approved allergy tablets so far for only four allergens.

Research contact: @DrJAshton

Bail on kale: It has too many pesticides!

March 21, 2019

Americans have been nothing short of kale-obsessed for the past few years: In fact—following a flirtation with broccoli in the 1980s and pesto in the 1990s—we have become so fixated on the leafy, green vegetable that it has seen a 400% increase on U.S. restaurant menus since 2008, according to Technomic, a research service for the food and beverage industry.

But foodies should get ready to move on to another “k-food” in the near future—maybe kelp, or kimchi, or kefir or kombucha. An annual study by a nonprofit environmental group has found that—despite its high levels of calcium, iron, and vitamins A and K —kale just might be less healthful than you think.

Interestingly enough, Kale ranked third on the Environmental Working Group’s “2019 Shopper’s Guide to Pesticides in Produce”—a list of the fruits and vegetables with the highest pesticide residues, according to a recent report by Fortune magazine. That was a big jump for the leafy green, which hasn’t appeared at all on the list since 2009.

“More than 92% of kale samples had two or more pesticide residues detected, and a single sample could contain up to 18 different residues,” the report read.

Strawberries and spinach took the number one and two spots, respectively, the business news outlet reported. Kale and spinach samples had, on average, 1.1 to 1.8 times more pesticide residue by weight than any other crop, said the EWG.

Other foods on the Dirty Dozen list, in decreasing order of their pesticide residues, include: nectarines, apples, grapes, peaches, cherries, pears, tomatoes, celery, and potatoes.

The annual study looks at pesticide levels on nearly 41,000 fruits and vegetables that are tested by the Food and Drug Administration and the Department of Agriculture.

Unlike other pesticide-focused studies, this one does not search for a specific brand, such as the weed killer used in Roundup.

Pesticides are regularly used in agriculture, of course, and food service companies say the levels are far below those that have been found to be unsafe for human consumption.

Not all fruits and veggies were denigrated, however. The EWG also put out its “Clean 15” list of the produce with the lowest levels of pesticide residue. Avocados topped that list, followed by sweet corn, pineapples, frozen sweet peas, onions, papayas, eggplants, asparagus, kiwis, cauliflower, cantaloupes, broccoli, mushrooms, and honeydew melons. .

Research contact: @ewg