Losartan Recall Expands As Torrent Recalls Five More Lots

The Losartan recall continues to expand after the Food and Drug Administration (FDA) announced the recall of additional lots of the blood pressure medication due to fears of carcinogen contamination. The latest Losartan recall includes five lots manufactured by Torrent Pharmaceutical after the medication was found to contain unsafe levels of N-methylnitrosobutyric acid, or NMBA.

Why is NMBA Dangerous?

NMBA is a known animal carcinogen and believed to be a potential human carcinogen. Like NDEA and NDMA, the compounds found in previous Losartan and Valsartan recalls,  long term exposure to NMBA at unsafe levels could lead to development of certain types of cancers, including:

  • Liver Cancer
  • Stomach Cancer
  • Colon Cancer
  • Intestinal Cancer
  • Prostate Cancer
  • Lower Esophageal Cancer
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Pancreatic Cancer

When Was this Losartan Recall Announced?

The FDA announced the latest Torrent Losartan recall on September 19, 2019, and the company issued a formal announcement of the recall on September 23. This latest recall marks the sixth time that Torrent has recalled lots of its Losartan products due to potential carcinogen contamination since the recalls began in 2018.

Which Lots of Losartan Were Recalled?

The lots included in this latest Losartan recall are listed below:

NDC
Product Name, Strength and Package Count
Batch Number
Expiration Date
13668-409-10
Losartan Potassium Tablets, USP 50mg, 1000 count
4DU2E009
12/31/2020
13668-115-90
Losartan Potassium Tablets, USP 100mg, 90 count
4DU3E009
12/31/2020
13668-115-10
Losartan Potassium Tablets, USP 100mg, 1000 count
4DU3E018
02/28/2021
13668-116-90
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count
BEF7D051
11/30/2020
13668-118-90
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.
4P04D007
07/31/2020

GoldenbergLaw Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Losartan for at least a year, received a Losartan recall letter, and has been diagnosed with prostate cancer (before age 60), lower esophageal cancer, non-hodgkins lymphoma, leukemia, multiple myeloma, colon, stomach, intestinal, or pancreatic cancer. If you or a loved one has taken Losartan and been diagnosed with one of these cancers, please contact us today for a free consultation. We have over 30 years of experience holding drug manufacturers accountable for negligence, let us deliver the Gold Standard advocacy you deserve.

The FDA Steps In To Fight JUUL & The Vaping Epidemic

The government is finally fighting back against the burgeoning e-cigarette industry as the vaping epidemic ravages teens with addiction and a mysterious lung illness that has hospitalized hundreds and claimed multiple lives. On September 9, federal officials at the Food and Drug Administration issued two warning letters to e-cigarette giant JUUL attacking its claims that its e-cigarette products are a safer alternative to smoking other tobacco products and requesting documents about its marketing practices and nicotine formula. Just two days later, the Trump Administration announced that it was investigating banning all flavored e-cigarettes.

What Did the FDA’s Letters Say?

JUUL markets their e-cigarette products as “modified risk tobacco products,” which means that the products have a lower risk of tobacco-related illnesses or are less harmful than other marketedjuul-e-cigarettes tobacco products. However, in order to advertise a product as a “modified risk tobacco product”, a company must have authorization from the FDA and JUUL has not received this authorization. The FDA reports that, as a result, “JUUL has ignored the law.

In a separate letter, the FDA expressed concern that JUUL’s marketing strategies involved targeting underage users by advertising on social media sites popular among teenagers and using influencers and coupons to entice new customers. The FDA also requested additional information from the company about its use of a special nicotine-salt e-liquid that possibly intensifies the addictiveness of its products.

What Is The Trump Administration’s Position?

On September 11, President Trump announced his administration was taking steps to remove all flavored vaping products from the market, with the exception of tobacco-flavored products. Health and Human Services Secretary Alex Azar shared that the number of teens who say they have vaped increased from 3.6 million in 2018 to 5 million in 2019. These shocking numbers, combined with increasing reports of hospitalizations and deaths linked to vaping-related lung injuries, have increased the Administration’s sense of urgency to place tighter regulations on the e-cigarette industry.

What Happens Next?

According the changes proposed by Azar, manufacturers of any flavored e-cigarette products would have to gain FDA approval to resume sales, which would involve proving that the benefits of the products outweigh the risks. The FDA initially set a deadline of 2021 for the agency to require manufacturers to apply for approval while the agency reviewed the safety of the products. However, a judge recently moved that deadline up to July 2020 and the FDA now says that date could be imminent.

In addition, the FDA demanded that JUUL immediately corrects the modified-risk violations or the company will face tougher enforcement actions such as penalties and possible product seizures.

What Led to the FDA’s Warning Letter?

The FDA reviewed testimony from the House Oversight and Reform subcommittee, which had been investigating JUUL’s marketing and promotional practices. In July hearings, JUUL was accused of “deploying a sophisticated program” targeting children and teenagers, including marketing at schools and summer camps, to become the largest seller of e-cigarettes in the country.

The Dangerous Side-Effects of JUUL & E-Cigarette Products

As of September 12, 2019, the Center for Disease Control and Protection has identified over 380 possible cases from 36 states of lung illnesses tied to the use of e-cigarettes and vaping products. So far there have been six confirmed deaths from lung illnesses associated with e-cigarette use.

What Should I Do If My Child Was Harmed After JUUL E-Cigarette Use?

If you or a loved one has been harmed after the use of a JUUL e-cigarette, contact the attorneys at GoldenbergLaw. With over 30 years of experience fighting corporate negligence, we deliver the Gold standard advocacy you deserve.

JUUL E-Cigarettes: Addicting and Injuring Teens With The Help of Social Media

Between June and August of 2019, there have been more than 215 reports of serious lung disease and other health concerns across 25 states tied to e-cigarette use. The first death from severe respiratory illness in connection with e-cigarette use occurred in Illinois in August 2019. As a result, public health officials have begun to further investigate the dangers of “vaping,” specifically the impact it can have on the lungs of adolescents. Many e-cigarette companies aggressively promote their products as a safer alternative to smoking, but an increasing amount of evidence suggests that may not be the case.

e-cig-pod

What are E-Cigarettes?

E-Cigarettes are electronic devices that use a battery to heat a liquid and produce a mix of particles known as an aerosol. The aerosols usually contain nicotine, flavorings, and other chemicals that are then inhaled by the user. The use of e-cigarettes is commonly referred to as ‘vaping.’

E-Cigarettes come in many shapes, styles, and sizes. Some e-cigarettes are designed to look like traditional cigarettes, while others look like USB flash drives, pens, and other everyday products.

What is JUUL?

JUUL is a Silicon Valley e-cigarette startup recently valued at $15 billion. In recent years, JUUL’s popularity has soared and now amasses 70% of the e-cigarette market. Although the company is partially owned by Altria, the tobacco company behind Marlboro cigarettes, JUUL maintains that their e-cigarette products are intended for adult smokers who want to transition from smoking traditional cigarettes.

What Do JUUL’s E-Cigarettes Look Like?

Similar to most e-cigarettes, JUUL products are battery-powered and heat a nicotine-containing liquid to produce an aerosol. However, stylistically, JUUL products resemble USB flash drives.

What’s Inside the Aerosol in JUUL E-Cigarettes?

JUUL e-cigarettes contain a high level of nicotine. According to the manufacturer, a single JUUL pod contains as much nicotine as a traditional pack of 20 cigarettes.

In addition to the high levels of nicotine, JUUL e-cigarette aerosols contain harmful and potentially harmful substances such as ultrafine particles that can be inhaled deep into the lungs, flavoring chemicals such as diacetyl which is linked to a serious lung disease, volatile organic compounds, cancer-causing chemicals, and heavy metals such as nickel, tin, and lead.

Danger of using JUUL: Nicotine Use in Adolescents

According to the U.S. Surgeon General, there are extensive dangers of adolescents using products that contain nicotine, such as JUUL e-cigarettes. These dangers include:

  • Negative impacts on the developing brain such as disrupting the formation of brain circuits that control attention, learning, and susceptibility to addiction
  • Long-term effects such as mood disorders and lowered impulse control
  • A more activated limbic system which leads to greater risk of addiction
  • High probability of using other tobacco products in the future

Danger of using JUUL: Exposure to Diacetyl

Diacetyl is a flavoring chemical frequently found in e-cigarettes that can cause irreversible conditions such as bronchiolitis obliterans, also known as “popcorn lung.” Exposure to diacetyl may lead lungs-smokingto the chemical seeping into the lung’s smallest airways, the bronchioles, which then become inflamed, damaged, and scarred. The scarred bronchioles block the movement of air in the lungs.

How Common is Exposure to Diacetyl?

In a study conducted by the Environmental Health perspectives, 51 flavors of e-cigarettes were tested and diacetyl was detected in 39 of the aerosols.

How Popular are E-Cigarettes Among Adolescents?

Among adolescents and teenagers, e-cigarettes are more popular than traditional cigarettes. In 2017 and 2018, polls discovered a 78% increase in e-cigarette use among high schoolers and a 48% increase among middle schoolers. Additionally, more than 2/3 of high school users choose e-cigarettes that offer flavors – such as JUUL products – because they seem ‘safer’ than traditional cigarettes. The drastic increase in e-cigarette use among young people has resulted in the Food and Drug Administration calling teen vaping an “epidemic.”

Why are Kids Using JUUL?

Social influence, enticing flavors, and JUUL marketing strategies presenting e-cigarettes as a ‘safer’ alternative for traditional cigarettes appear to have increased JUUL product usage among adolescents.

There is increased concern and public backlash over JUUL’s marketing strategies which appear to be targeting young people. According to Tobacco Control Journal, JUUL stands out from other e-cigarette companies by marketing their devices on social media platforms such as Twitter, YouTube, and Instagram which are especially popular with young people. Researchers claim that the combination of the company’s marketing efforts, their product offerings such as sleek designs mimicking USB flash drives, and candy-like flavors have resulted in more young people becoming hooked on nicotine and using e-cigarettes.

What is JUUL Saying About the Dangers?

JUUL co-founder James Monsees acknowledged the statistics showing “a significant number of underage Americans using e-cigarettes, including JUUL products”.

JUUL CEO Kevin Burns even issued a public apology to parents of teens who are addicted to the company’s vaping products saying, “First of all, I’d tell them that I’m sorry that their child’s using the product.”

Burns also warned nonsmokers against using JUUL products “Don’t vape. Don’t use JUUL” in addition to acknowledging that the long-term effects of vaping are unknown. However, JUUL continues to sell e-cigarettes and market their products on platforms frequented by young people.

How Do I Know if My Loved One has been Harmed by JUUL?

Symptoms of Bronchiolitis Obliterans include:

  • Shortness of breath
  • Fatigue
  • Chest pain
  • Cough
  • Weight loss
  • Nausea
  • Vomiting
  • Fever
  • Trouble doing routine tasks such as washing one’s hair or tying shoes
  • Difficulty breathing

If you or a loved one has experienced these symptoms after using vaping, please contact a healthcare professional.

What Should I Do If My Child Was Harmed After JUUL E-Cigarette Use?

If you or a loved one has been harmed after the use of a JUUL e-cigarette, contact the attorneys at GoldenbergLaw. With over 30 years of experience fighting corporate negligence, we deliver the Gold standard advocacy you deserve.