FDA Warns: Hand Sanitizers with Toxic Chemical

COVID-19 Update from the FDA: The FDA Warns Against the Use of 9 Hand Sanitizers Potentially Containing a Toxic Chemical

On June 22, 2020, the Food and Drug Administration (FDA) announced that consumers should avoid using 9 hand sanitizers that may contain a potentially fatal ingredient–methanol (wood alcohol). Exposure to methanol could be toxic if absorbed through the skin or ingested.

Which Hand Sanitizers are Listed in the Warning?

The FDA identified the following products manufactured by Eskbiochem in the warning:

  • All-Clean Hand Sanitizer (NDC: 74589-002-01)
  • Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
  • CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
  • Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
  • The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
  • CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
  • CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
  • CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
  • Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)

What is the Evidence?

The FDA tested samples of Lavar Gel and CleanCare No Germ for menthanol. Lavar Gel contains 81% methanol and no ethyl alcohol, and CleanCare No Germ contains 28% methanol.

Who Manufactures These Hand Sanitizers?

On June 17, 2020, the FDA contacted the Mexican manufacturing company of the hand sanitizers, Eskbiochem, to recommend that the company remove its hand sanitizer products from the market due to the risks associated with methanol poisoning. However, currently, the company has not taken action to remove these products from the markets.

What is Methanol?

Methanol is commonly known as wood alcohol. The FDA says that it “is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.”

Methanol was once manufactured by the distillation of wood. Wood alcohol was a danger for drinkers during Prohibition. In New York in 1926, about 750 people died after drinking bootlegged liquor that contained wood alcohol.

What Should I Do If I Have Been Exposed to Methanol in Hand Sanitizers?

Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment which is vital for potential reversal of toxic effects of methanol positioning.

Substantial methanol exposure may lead to:

  • Nausea
  • Vomiting
  • Headache
  • Blurred vision
  • Permanent blindness
  • Seizures
  • Coma
  • Permanent damage to the nervous system
  • Death

The FDA recommends that consumers stop using these hand sanitizers and dispose of them immediately in appropriate hazardous waste containers. Do not flush these products or pour them down the drain.

Who Is Most at Risk for Methanol Poisoning?

All persons who use the listed hand sanitizers on their skin or have ingested the products are at risk. However, young children who may ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

What is the FDA Saying About Other Hand Sanitizer Manufacturers?

The FDA also expressed their concerns about other hand sanitizer companies inaccurately promoting their products as providing protection against viruses- such as COVID-19- because “there is no evidence to support these claims.”

The FDA warned the maker of Purell hand sanitizer to stop marketing their hand sanitizers as reducing or preventing diseases, citing lack of “adequate and well-controlled studies” to support the marketing claims.

The COVID-19 pandemic caused a surge in hand sanitizer sales. In March 2020, the FDA attempted to boost the production of hand sanitizers.

In April 2020, the FDA said that it will be seeking additional information about the effectiveness and safety of three active ingredients found in over-the-counter hand sanitizers: benzalkonium chloride, ethyl alcohol and isopropyl alcohol.

After research, the FDA concluded that 28 other active ingredients cannot be used in those antiseptic rubs anymore.

A few companies have been sued over inaccurate marketing claims, including Germ-X manufacturer Vi-Jon Inc. and hand sanitizer company BioDefense Inc.

In May 2020, a California federal judge sided with the U.S. Department of Justice (DOJ) in halting BioDefense from marketing their products as protecting against a range of infectious diseases.

How GoldenbergLaw Can Help You

Our product liability attorneys in Minnesota have 30 years of experience working with many different types of products. Contact our team today and leave the sleepless nights to us. Allow us to give you the Gold standard of advocacy that you deserve.

 

Fatal Car Crash on I-35W in Minnesota

What Happened on I-35W?

On Saturday, June 20 on Interstate 35W in Richfield, Minnesota, 4 people died and another person suffered life-threatening injuries in a wrong-way crash.

Minnesota State Patrol reported that a Nissan Murano SUV was traveling southbound in the northbound lanes of I-35W near 66th Street when it crashed into a GMC Terrain SUV going northbound just before 10pm on June 20.

The accident report revealed that 3 out of the 4 people in the GMC Terrain SUV died at the scene and the fourth individual was taken to Hennepin County Medical Center with “life-threatening injuries.”

The driver was the only person in the Nissan Murano SUV and died at the scene.

Increase in Fatal Car Crashes Since the COVID-19 Lockdown

A report from the National Safety Council (NSC) reveals that fatalities from motor vehicle crashes spiked 14% in the month of March during the COVID-19 quarantines. The NSC found that for every 100 million miles driven in March 2020, there were 1.22 deaths on the road, compared with 1.07 in March 2019. 42 people were killed in traffic collisions in the first 45 days after Minnesota’s March 16 stay-at-home order went into effect.

This increase in traffic fatalities occurred despite the actual number of miles driven dropping 18.6% compared to the same time period last year.

Lorraine M. Martin, President and CEO of the National Safety Council said, “Disturbingly, we have open lanes of traffic and an apparent open season on reckless driving.”

Increase in Dangerous Driving During COVID-19

Authorities claim that speeding, careless driving and blowing through red lights are the main causes of the deadly crashes.

In the five weeks after many states announced lockdown orders on March 16, the data company Zendrive said drivers’ use of cell phones while driving is up 38% over pre-lockdown numbers. The number of drivers who exceeded speed limits had also increased by 27%, hard braking increased by 25%, and collisions per million miles increased by 20%.

Minnesota State Patrol Lt. Gordon Shank reports that Minnesota has also seen a big increase in people speeding with fatal consequences: “In April 2019, Minnesota State Patrol reportedly stopped 58 people who were allegedly driving over 100mph. This April, they stopped 143 drivers doing at least 100 which is an 146% increase. The higher the speeds, less reaction time, the more injuries we have, the more fatal crashes we have.”

Michael Hanson, the director of the Office of Traffic Safety in Minnesota, said, “We’re getting reports every week of dozens of drivers being cited for traveling over 100 miles an hour. That’s just insanity for our roadways.”

The Zendrive report explained that, “As a result, every minute spent on the road is riskier, every mile is riskier. The data shows our anxiety over social distancing and growing attachment to screen has carried over into our driving habits.”

How GoldenbergLaw Can Help You

If you are in need of a car accident attorney in Minnesota or Wisconsin, reach out to today and get a free consultation. There is no obligation and no fee unless we win you the case. Reach out today and leave the sleepless nights to us.

 

FDA Pulls Emergency Use Authorization for Hydroxychloroquine for COVID-19 Treatment

FDA Revokes Emergency Use Authorization:

On June 15, 2020, the Food and Drug Administration (FDA) rescinded the Emergency Use Authorization (EUA) allowing hospital patients to use certain malaria medications such as hydroxychloroquine and chloroquine for treating COVID-19. The announcement warned that these medicines “are unlikely to be effective in treating COVID-19 for the authorized use in the EUA” and that “the totality of scientific evidence currently available indicate a lack of benefit.”

Furthermore, the announcement also cited a non-clinical study that administered the two drugs along with Gilead’s remdesivir COVID-19 medication and the presence of the malaria drugs “may result in reduced antiviral activity of remdesivir.”

Why Did the FDA Revoke the Emergency Use Authorization?

The FDA stated in their announcement: “In light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits” of hydroxychloroquine no longer outweigh those risks.”

The June 15 announcement comes less than 2 months after the FDA warned patients and caregivers that hydroxychloroquine and chloroquine have been linked to life-threatening heart rhythm problems. The FDA reiterated this warning in the June 15 announcement, stating that hydroxychloroquine and chloroquine have been connected to “ongoing serious cardiac adverse events and other potential serious side effects.”

March 2020

The EUA was first issued in March 2020 and applied to patients who were hospitalized with COVID-19 and those in clinical trials. However, in April the FDA warned doctors against prescribing the drug to COVID-19 patients outside of hospitalization and clinical trial conditions.

Since the FDA granted the EUA, researchers have reported that patients treated with the medications have died at a higher rate than those receiving regular treatment for COVID-19.

April 2020

In April 2020, the FDA issued a warning telling patients and caregivers that malaria drugs (such as hydroxychloroquine and chloroquine) have been reported to have serious and life-threatening side effects when used to treat the disease. The announcement also included the warning that patients with other health issues, such as heart and kidney disease, are likely to be at an increased risk of heart problems when taking hydroxychloroquine and chloroquine.

June 2020

Just prior to the June 15 announcement, research from the University of Minnesota Medical School published in the New England Journal of Medicine found that hydroxychloroquine was no more effective than a placebo at preventing COVID-19 symptoms among people exposed to coronavirus.

This is the first major clinical trial analyzing whether the medication might be useful as a prophylactic. The study focused on 821 people who had been in close contact with a confirmed COVID-19 patient—putting those 821 people at an increased risk of developing COVID-19 themselves.

Study participants were sent doses of either hydroxychloroquine or a placebo and asked to take the pills for two weeks. The study was double-blind—neither the study participants nor the researchers knew in advance which people would be getting the real medication.

At the end of the two weeks, there was virtually no difference in who developed COVID-19 symptoms. 12% of those given hydroxychloroquine reported symptoms, compared with 14% of those who were given a placebo.

What is Hydroxychloroquine and What Does It Do?

Hydroxychloroquine is a drug traditionally used to treat malaria and certain autoimmune conditions, such as lupus and rheumatoid arthritis. However, the FDA’s June 15 announcements do not apply to the drug’s treatment of these conditions.

Hydroxychloroquine first gained attention as a potential COVID-19 treatment in February 2020 when two small studies suggested that it might be useful against the COVID-19 virus.

President Donald Trump encouraged its use, even saying in May 2020 that he took hydroxychloroquine to prevent COVID-19.

How Do I Know If I Have Been Harmed?

Common Side Effects Include:

  • Headache
  • Dizziness
  • Diarrhea
  • Stomach cramps
  • Vomiting

Serious Side Effects:

  • Blurred vision or other vision changes (may be permanent in some cases)
  • Heart disease, heart failure, issues with heart rhythm (some cases have been fatal)
  • Ringing in your ears or hearing loss
  • Angioedema (rapid skin swelling)
  • Hives
  • Mild or severe bronchospasm (tightening of muscles that line the lungs’ airways)
  • Persistent sore throat
  • Hypoglycemia (low blood sugar)
  • Unusual bleeding or bruising
  • Blue-black skin color
  • Muscle weakness
  • Hair loss or changes in hair color
  • Abnormal mood changes
  • Mental health effects, including suicidal thoughts

Symptoms of Heart Disease, Heart Failure, and Heart Rhythm Issues:

  • Shortness of breath
  • Swelling of ankles/feet
  • Unusual tiredness
  • Unusual/sudden weight gain
  • Symptoms of Hypoglycemia (low blood sugar)

Symptoms of Hypoglycemia (low blood sugar)

  • Sudden sweating or shaking
  • Hunger
  • Blurred vision
  • Dizziness
  • Tingling hands or feet

How GoldenbergLaw Can Help You

The attorneys at GoldenbergLaw have handled dangerous drug cases for more than 30 years and will provide you with the Gold standard of advocacy that you deserve.