Posted in diabetes, Health, medications, news

Diabetes Drug Investigated for Cancer-Causing Contaminant

This week the FDA reported they would investigate if metformin, a popular diabetic drug, contained NDMA within the US market.

NDMA, N-nitrosodimethylamine, is a known carcinogen in a wide range of animal species.  It’s in the class of nitrosamines, which may be genotoxic (altering the genetic material in cells causing them to mutate) and cancer-causing in those who are exposed to unacceptable levels for long periods of time. The “acceptable range” according the FDA is 96 ng per day.

The FDA on their website states the following:

The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA. Based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water. While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time. The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found. If as part of our investigation, metformin drugs are recalled, the FDA will provide timely updates to patients and health care professionals.

So no recalls have been initiated at this time.

According to Reuters, earlier last summer, the MHRA, Medicines and Healthcare Products Regulatory Agency, located in the UK, said the appearance of the impurity, N-nitrosodimethylamine (NDMA), came after a change in the process for making valsartan at one facility owned by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

I suspect more investigations or recalls will follow as processes may be similar across multiple pharmaceutical facilities and NMBA, NDMA and NDEA (discussed below) are byproducts that may not be individually unique to just one “brand” of medication manufacturing.

Generic Zantac Being Investigated for NDMA

The FDA has announced that samples of ranitidine, an H2 Blocker used for stomach upset, reflux and ulcers sold generically and under the brand name of Zantac, were found to have the contaminant NDMA.  This is one of the chemicals that prompted the generic ARB blood pressure medication recalls last year.

There have been no reports of users becoming ill and no recall has been suggested at this time. In animals, NDMA is known to cause liver and lung cancer.  In humans its carcinogenic risk is unknown, however the CDC states it may cause liver function impairment and cirrhosis.

The FDA writes:

THE FDA IS NOT CALLING FOR INDIVIDUALS TO STOP TAKING RANITIDINE AT THIS TIME; HOWEVER, PATIENTS TAKING PRESCRIPTION RANITIDINE WHO WISH TO DISCONTINUE USE SHOULD TALK TO THEIR HEALTH CARE PROFESSIONAL ABOUT OTHER TREATMENT OPTIONS. PEOPLE TAKING OTC RANITIDINE COULD CONSIDER USING OTHER OTC MEDICINES APPROVED FOR THEIR CONDITION. THERE ARE MULTIPLE DRUGS ON THE MARKET THAT ARE APPROVED FOR THE SAME OR SIMILAR USES AS RANITIDINE.
CONSUMERS AND HEALTH CARE PROFESSIONALS SHOULD REPORT ANY ADVERSE REACTIONS WITH RANITIDINE TO THE FDA’S MEDWATCH PROGRAM TO HELP THE AGENCY BETTER UNDERSTAND THE SCOPE OF THE PROBLEM:

The investigation is ongoing and more needs to be looked at when it comes to this manufacturing process suspected to result in these “impurities” being made.

Last year NDEA was also found in the generic  blood pressure medications that were the subject of recall, however has not yet been suggested as being being present in ranitidine.

N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was the third chemical detected resulting in the latest two recalls of losartan, an angiotensin receptor blocker commonly used to treat hypertension (high blood pressure).  It is believed to have been created during the manufacturing process of the generic drug.

pills.jpg

 

Last Fall, ScieGen Pharmaceuticals, Inc. recalled certain lots of irbesartan, a similar angiotensin receptor blocker used in blood pressure management.

The recalls initially began last summer when FDA recalled a number of lots of valsartan due to an “impurity”, N-nitrosodimethylamine (NDMA) that is known to cause cancer in animals.  Weeks later they additionally found traces of N-nitrosodiethylamine (NDEA).

With NDEA, data is limited, but due to its classification as a nitrosamine and its prevalence in tobacco smoke it is classified as a probable human carcinogen.

According to New Jersey Department of Health’s website, NDEA has been linked to liver, lung and gastrointestinal tract cancer in animals.

Losartan, valsartan and irbesartan are medications in the class of angiotensin receptor blockers (ARBs) used for high blood pressure and congestive heart failure.

Those taking either tablet for their blood pressure, stomach acid issues, or diabetes are urged to not abruptly stop their medication but rather check with their medical provider and pharmacy to see if their particular prescription is involved in the recall or investigation.

 

 

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Great Gift!!!

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Daliah Wachs, MD, FAAFP is a nationally syndicated radio personality on GCN Network, KDWN, and iHeart Radio.

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Posted in food, Health, news

E. Coli Romaine Lettuce Outbreak Declared “Over” by FDA

The FDA has disclosed a new E. coli romaine lettuce outbreak, that has supposedly ended.

23 people from 12 states have become ill due to this recent outbreak of E. coli. 

No deaths have been reported.

The Shiga toxin-producing E. coli O157:H7 sickened 23 people and hospitalized 11 between the dates July 12 and September 8th, with cases occurring in Arizona, Florida, Georgia, Illinois, Maryland, North Carolina, Nevada, New York, Oregon, Pennsylvania, and South Carolina, with the majority of cases in California.

The FDA emphasizes that they believe the outbreak is over.  However many wonder why they this wasn’t disclosed earlier.

The CDC did appear to begin its investigation earlier this Fall, and forward their concerns to the FDA, but jointly the disclosure didn’t come until now.

On their website, the FDA reports the following:
Today, the U.S. Food and Drug Administration is sharing news of a recent E. coli O157:H7 outbreak, involving 23 illnesses, that was likely associated with romaine lettuce. No deaths were reported. The active investigation has reached its end and the outbreak appears to be over. The FDA and the U.S. Centers for Disease Control did not identify actionable information for consumers during this investigation. Additionally, when romaine lettuce was identified as the likely source of the outbreak, the available data at the time indicated that the outbreak was not ongoing and romaine lettuce eaten by sick people was past its shelf life and no longer available for sale. The FDA is communicating details about the outbreak at this time to help ensure full awareness by the public and to highlight the ongoing importance of industry actions to help ensure the safety of leafy greens. Federal health officials do not believe there is a current or ongoing risk to public health.
CDC notified the FDA of this illness cluster in mid-September 2019 and the agency promptly initiated a traceback investigation. The FDA, CDC, along with state and local partners, investigated the illnesses associated with the outbreak. A total of 23 people infected with the outbreak strain of E. coli O157:H7 were reported from 12 states: Arizona (3), California (8), Florida (1), Georgia (1), Illinois (2), Maryland (1), North Carolina (1), Nevada (1), New York (1), Oregon (1), Pennsylvania (2) and South Carolina (1). Eleven people were hospitalized and no deaths were reported. Illnesses started on dates ranging from July 12, 2019 to Sept. 8, 2019. No illnesses were reported after CDC began investigating the outbreak on Sept. 17, 2019.
Investigators were sent to visit farms located in California’s central coast region which were identified through the traceback investigation. They collected and tested many environmental samples, and the outbreak strain was not identified. While romaine lettuce is the likely cause of the outbreak, the investigation did not identify a common source or point where contamination occurred. Since the outbreak strain was not detected in samples collected from farms during the traceback investigation, and there have been no new cases since Sept. 8, 2019, the outbreak appears to be over.
The FDA remains committed to improving the safety of leafy greens and traceability from farm to fork.

Symptoms of E. coli poisoning can occur anywhere from 1-10 days after ingestion.

They include:

  • Nausea
    Vomiting
    Diarrhea, may be bloody
    Fever
    Chills
    Body Aches
    Abdominal Cramps

And if progresses, can cause

  • Shortness of Breath
    Nose bleeds
    Anemia
    Dehydration
    Seizures
    Renal Failure
    Death

Exposure to E. coli may occur from exposure to contaminated foods (from human or animal waste) or undercooked meats.

Daliah Wachs, MD, FAAFP is a nationally syndicated radio personality on GCN Network, KDWN, and iHeart Radio.

Posted in cancer, Health, medications, news

Ranitidine Being Evaluated For Cancer Causing Chemical

The FDA has announced that samples of ranitidine, an H2 Blocker used for stomach upset, reflux and ulcers sold generically and under the brand name of Zantac, were found to have the contaminant N-nitrosodimethylamine (NDMA).  This is one of the chemicals that prompted the generic ARB blood pressure medication recalls last year.

There have been no reports of users becoming ill and no recall has been suggested at this time. In animals, NDMA is known to cause liver and lung cancer.  In humans its carcinogenic risk is unknown, however the CDC states it may cause liver function impairment and cirrhosis.

The FDA writes:

The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.
Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the scope of the problem:

The investigation is ongoing and more needs to be looked at when it comes to this manufacturing process suspected to result in these “impurities” being made.

Last year NDEA was also found in the generic  blood pressure medications that were the subject of recall, however has not yet been suggested as being being present in ranitidine.

N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was the third chemical detected resulting in the latest two recalls of losartan, an angiotensin receptor blocker commonly used to treat hypertension (high blood pressure).  It is believed to have been created during the manufacturing process of the generic drug.

pills.jpg

NMBA, according to Toronto Research Chemicals, is a known carcinogen in a wide range of animal species.

Last Fall, ScieGen Pharmaceuticals, Inc. recalled certain lots of irbesartan, a similar angiotensin receptor blocker used in blood pressure management.

The recalls initially began last summer when FDA recalled a number of lots of valsartan due to an “impurity”, N-nitrosodimethylamine (NDMA) that is known to cause cancer in animals.  Weeks later they additionally found traces of N-nitrosodiethylamine (NDEA).

According to Reuters, earlier last summer, the MHRA, Medicines and Healthcare Products Regulatory Agency, located in the UK, said the appearance of the impurity, N-nitrosodimethylamine (NDMA), came after a change in the process for making valsartan at one facility owned by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

With NDEA, data is limited, but due to its classification as a nitrosamine and its prevalence in tobacco smoke it is classified as a probable human carcinogen.

According to New Jersey Department of Health’s website, NDEA has been linked to liver, lung and gastrointestinal tract cancer in animals.

Losartan, valsartan and irbesartan are medications in the class of angiotensin receptor blockers (ARBs) used for high blood pressure and congestive heart failure.

Those taking either tablet for their blood pressure are urged to not abruptly stop their medication but rather check with their medical provider and pharmacy to see if their particular prescription is involved in the recall.

I suspect more recalls will follow as processes may be similar across multiple pharmaceutical facilities and NMBA, NDMA and NDEA are byproducts that may not be individually unique to just one “brand” of medication manufacturing.

 

ultimate book cover final

Great Gift!!!

The Ultimate Medical Student HandBook

 

Daliah Wachs, MD, FAAFP is a nationally syndicated radio personality on GCN Network, KDWN, and iHeart Radio.

Posted in Health, news, vaping

More Reports of Vaping Linked to Seizures in Teens

The FDA is investigating 127 reports of seizures in e-cigarette users (up from 35 this Spring).

Many were teenagers and young adults.

Since 2010 the agency has received multiple reports but is unclear if e-cigarettes actually caused the seizures or if there were underlying medical conditions predisposing the neurological disorder.

The 92 additional cases since this April is concerning and the FDA is working to determine if vaping contributes contributes directly to serious neurological conditions.

In April FDA Commissioner Dr. Scott Gottlieb tweeted:

While we’re still learning about the long-term potential benefits and health risks of e-cigs, existing scientific research offers some clear evidence that several of the dangerous chemicals in tobacco smoke are also present in the aerosol of some e-cig products.

Dr. Ned Sharpless, current acting FDA Commissioner, is encouraging people to report adverse events as, “Additional reports or more detailed information about these incidents are vital to help inform our analysis and may help us identify common risk factors and determine whether any specific e-cigarette product attributes, such as nicotine content or formulation, may be more likely to contribute to seizures,” (Reported by CNBC).

What is a seizure?

A seizure occurs when there is abnormal electrical activity in the brain.  If the electricity doesn’t conduct properly, brain function gets disrupted. This could lead to convulsions  (involuntary jerking movements), loss of muscle tone, changes in senses such as vision, hearing and smell, loss of bladder control, loss of consciousness and sometimes stroke, brain damage and death.

HGT0066_neurons-seizure-brain_FS.jpg

 

Nicotine toxicity has been linked to seizures.  E-cigs sometimes contain more nicotine than cigarettes alone.

 

_________________________________________________________________________________________

A study published by the American Heart Association found nine different E-cig flavors  to impair blood vessel function, which can impair heart health.

Endothelial cells, which delicately line blood and lymph vessels, were found to become inflamed at low concentrations of some vapor flavors.  And at high concentrations of others, exibited cell death.  Nitric oxide production, necessary for vessel dilation to improve blood flow, was impaired as well. These are often the same changes seen in early heart disease.

sample_01001118_110141.jpg

The 9 flavors (and the chemicals within) cited in the report to cause the endothelial inflammation and/or damage were:

  • Mint (menthol)
  • Vanilla (vanillin)
  • Clove (eugenol)
  • Cinnamon (cinnamaldehyde)
  • Strawberry (dimethylpyrazine)
  • Banana (isoamyl acetate)
  • Butter (diacetyl)
  • Eucalyptus/spicy cooling (eucalyptol)
  • Burnt flavor (acetylpyridine)

Strawberry flavoring appeared to have the most adverse effect on the cells.

Now many other flavors were not included in this study, so its unknown how safe they may be.

For more on the study, read here.

An alternate study published last November looked at vaping flavors and their effects on heart muscle cells.

For more on this study, read here.

The moral?  Just because we love the taste of something, doesn’t mean its safe to inhale.

___________________________________________________________________

Vaping Linked to Heart Disease and Cancer

 

A study from New York University found the nicotine in electronic cigarettes to cause DNA damage similar to cigarette smoking.

Dr. Moon-shong Tang and his colleagues exposed mice to e-cig smoke during a three-month period, 5 days a week for three hours a day.  They found these mice, compared to those breathing filtered air, to have DNA damage to cells in their bladders, lungs and hearts. The amount of nicotine inhaled was approximately 10mg/ml.   That dose would be commonly consumed by many humans who vape.

nicotine.jpg

They then looked at human bladder and lung cells and found tumor cells were able to grow more easily once exposed to nicotine and vaping chemicals.

Last May, researchers from Vanderbilt-Ingram Cancer Center in Nashville found e-cig smoke to increase one’s risk of bladder cancer.

In 2015, the University of Minnesota identified chemicals commonly found in e-cig vapor to include:

  • Formaldehyde (human carcinogen)
  • Acetaldehyde (carcinogen related to alcohol drinking)
  • Acrolein (highly irritating and toxic)
  • Toluene (toxic) NNN, NNK (tobacco carcinogens related to nicotine)
  • Metals (possible carcinogens and toxins)

Although electronic cigarette “juice” may appear safe, it could produce harmful chemicals once heated to become a vapor.

A lethal dose of nicotine for an adult ranges from 30-60 mg and varied for children (0.5-1.0 mg/kg can be a lethal dosage for adults, and 0.1 mg/kg for children).  E-cigs, depending on their strengths (0 – 5.4%) could contain up to 54 mg of nicotine per cartridge (a 1.8% e -cig would contain 18mg/ml).

The topic of nicotine increasing one’s vulnerability to cancer is nothing new as decades ago researchers found nicotine to affect the cilia (brush border) along the respiratory tree, preventing mucous production and a sweeping out of carcinogens trying to make their way down to the lungs.

More research needs to be performed but this recent report reminds us that exposing our delicate lung tissue and immune system to vaping chemicals may not be as safe as we think.

For more on the study read here.

Toxic metals found in vaping liquid

Last week, experts warned that many chemicals in vaping liquid may change to toxic substances (once heated) that can irritate the lungs.

Last year one study reported that toxic levels of lead and other metals may leak from the heating coil element into the vapor inhaled during e-cig use.

Researchers at Johns Hopkins Bloomberg School of Public Health found these metals to include:

  • lead
  • nickel
  • manganese
  • chromium
  • arsenic

We’ve known for some time that vaping fluid could contain chemicals that turn toxic once heated, but this study shed light on e-cig metal components causing metal leakage to the vapor making contact with delicate respiratory epithelium (lining).

Reported by Forbes, Rich Able, a medical device marketing consultant, stated the following, “the FDA does not currently test any of the most popular vaping and e-cigarette instruments being manufactured at unregulated factories in Asia that source  low-grade parts, batteries, and materials for the production of these devices,” suggesting that “the metal and parts composition of these devices must be stringently tested for toxic analytes and corrosive compounds.”

These chemicals may act as neurotoxins, affecting our nervous system, cause tissue necrosis (cell death) and even multi-organ failure.  Moreover they can affect how our immune system reacts to other chemicals as well as foreign pathogens, affecting our ability to fight other diseases.

Although studies have suggested e-cig vapor to be safer than tobacco smoke, not enough research has been done, in the relatively few years vaping has been around, looking at how heat-transformed chemicals and leaked metals affect our breathing, lungs and other organs once absorbed into the body.

 

ultimate book cover final

Great Gift!!!

The Ultimate Medical Student HandBook

 

Daliah Wachs, MD, FAAFP is a nationally syndicated radio personality on GCN Network, KDWN, and iHeart Radio.

Posted in Health, news, sunscreen

Sunscreen Chemicals DO Get Absorbed in the Blood

Many of us moms who hesitated lathering our kids up in perfumed sunscreen for fear of chemical absorption may have some evidence on our side.

The FDA and EWG (Environmental Working Group) looked at 24 volunteers who applied sunscreen (spray/lotion) 4 times a day for 4 days to 75% of their body.  They found levels of avobenzone, oxybenzone, octocrylene and ecamsule elevated in the blood samples of the men and women tested in the following days.

They results of this study were:

Among 24 participants randomized (mean age, 35.5 [SD, 1.5] years; 12 (50%] women; 14 [58%] black or African American; 14 [58%]), 23 (96%) completed the trial. For avobenzone, geometric mean maximum plasma concentrations were 4.0 ng/mL (coefficient of variation, 6.9%) for spray 1; 3.4 ng/mL (coefficient of variation, 77.3%) for spray 2; 4.3 ng/mL (coefficient of variation, 46.1%) for lotion; and 1.8 ng/mL (coefficient of variation, 32.1%). For oxybenzone, the corresponding values were 209.6 ng/mL (66.8%) for spray 1, 194.9 ng/mL (52.4%) for spray 2, and 169.3 ng/mL (44.5%) for lotion; for octocrylene, 2.9 ng/mL (102%) for spray 1, 7.8 ng/mL (113.3%) for spray 2, 5.7 ng/mL (66.3%) for lotion, and 5.7 ng/mL (47.1%) for cream; and for ecamsule, 1.5 ng/mL (166.1%) for cream. Systemic concentrations greater than 0.5 ng/mL were reached for all 4 products after 4 applications on day 1. The most common adverse event was rash, which developed in 1 participant with each sunscreen.
Conclusions and Relevance  In this preliminary study involving healthy volunteers, application of 4 commercially available sunscreens under maximal use conditions resulted in plasma concentrations that exceeded the threshold established by the FDA for potentially waiving some nonclinical toxicology studies for sunscreens. The systemic absorption of sunscreen ingredients supports the need for further studies to determine the clinical significance of these findings. These results do not indicate that individuals should refrain from the use of sunscreen.

…with oxybenzone having the highest persisting levels.

However, due to the alarming rates of skin cancer worldwide, no one is suggesting using less sunscreen. The purpose of this study is to encourage more safety studies by manufacturers.

Most People Apply Sunscreen Incorrectly

A new study has found the majority of people miss the most vulnerable parts of their face when applying sunscreen.

Published in PLOS One, researchers from the University of Liverpool looked at the sunscreen application habits of 84 men and women with the majority avoiding areas of the face around the eyes.

However, study authors cite the skin around the eyes is the most vulnerable to sun damage and skin cancer.  SPF containing moisturizers were used even less around the eyes.

The Sun reports:

AUSTIN MCCORMICK, STUDY AUTHOR AND CONSULTANT OPHTHALMIC AND OCULOPLASTIC SURGEON, FROM AINTREE UNIVERSITY HOSPITAL TRUST, SAID: “THE EYELID SKIN IS VERY THIN AND THIS PUTS IT AT RISK OF UV DAMAGE.
“THE AREA AROUND THE EYELASHES AND BETWEEN THE EYELIDS AND THE NOSE IS LEAST LIKELY TO BE COVERED.”
MR MCCORMICK SAID THAT EYELID CANCERS ACCOUNTED FOR 10 PER CENT OF ALL BASAL CELL CARCINOMAS IN THE UK – THE MOST COMMON TYPE OF SKIN CANCER.
HE ADDED THAT MOISTURISER MAY BE USED MORE SPARINGLY BECAUSE IT IS OFTEN EXPENSIVE AND SOLD IN SMALLER AMOUNTS.

My theory:  We’ve been told since we were kids to keep things away from our eyes, especially lotions.

How do sunscreens work?

Sunscreens use chemicals to disperse or absorb UV rays.  Inorganic compounds in sunscreen such a titanium dioxide or zinc oxide attempt to scatter the UV rays.  Organic compounds such as PABA and oxybenzone attempt to absorb UV rays so they can’t damage the skin.

 

What’s the difference between UVA and UVB radiation?

UVA rays penetrate deeply into both the epidermis and dermis.  They can cause premature aging of the skin, wrinkles, and skin cancer.

UVB rays are shorter and primarily affect the epidermis. They are responsible for causing sunburns as well as skin cancer.

8ce0498bca5aac49d757b683088b7d4a.jpg

What is SPF?

SPF stands for Sun Protection Factor.  The higher the SPF, the less sun photons enter the skin and cause damage.  SPF primarily measures the protection against UVB rays. We multiply the SPF factor by how long it takes one’s skin to burn by the SPF number to determine the protection factor.

In theory, an SPF of 30 suggests your skin, if it burns within 10 minutes without protection, will not burn until 300 minutes has lapsed (30 times 10).  However, we find this isn’t always the case.  People sweat or swim and the sunscreen dissipates.  Moreover many don’t put on the proper amounts (see below.)

So instead we use SPF as a grade to how much protection the product can offer.

An SPF of 15 blocks 93% of UVB rays

An SPF of 30 blocks 97% of UVB rays

An SPF of 50 blocks 98% of UVB rays

As we see, the relationship is not linear, however the higher the SPF, the more protection we have against UV rays..

what-is-spf-sunsreen-sun-protection-factor.JPG

IMAGE FROM BADGERBALM

 

Although the SPF alludes to protection against burning, hence UVB rays, a sunscreen may still protect against both UVA rays and UVB rays if it’s a broad spectrum sunscreen.

 

image-4@1-5.jpg.d3f15e8b9561ed8c3b2dd3679e8e79cb.jpg

How to apply sunscreen

Most people apply sunscreen incorrectly or unevenly.   Lotion needs to be applied at an amount of 2mg/cm2 of skin or 1 teaspoon per body part (chest, arm, leg, face and neck).  It should be applied 15 minutes prior to going out into the sun and needs to be reapplied every 2 hours, or more often if swimming or sweating.

CRM_Page_41_Important_Sunscreen_Spots_07-15 (1)

Daliah Wachs, MD, FAAFP is a nationally syndicated radio personality on GCN Network, iHeart Radio and Board Certified Family Physician

Posted in Health, medications, news

Fourth Recall Ordered for Popular Blood Pressure Medication

36 lots of losartan potassium and losartan potassium/hydrochlorothiazide have been initiated by Torrent Ltd Pharmaceuticals due to a detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).

There have been no reports of users becoming ill and the recall is being done out of precaution.

N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was the third chemical detected resulting in the latest two recalls of losartan, an angiotensin receptor blocker commonly used to treat hypertension (high blood pressure).  It is believed to have been created during the manufacturing process of the generic drug.

pills.jpg

The FDA reports:

Torrent Pharmaceuticals Limited is further expanding its voluntary recall to include 104 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets. This recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.
The agency updated the list of losartan products under recall accordingly.
FDA reminds patients taking recalled angiotensin II receptor blockers (ARBs) to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.
FDA is also posting new testing methods which can help manufacturers and international regulators detect and identify multiple nitrosamine impurities. FDA and international regulators have identified N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and NMBA in ARBs.

NMBA, according to Toronto Research Chemicals, is a known carcinogen in a wide range of animal species.

Earlier this Fall, ScieGen Pharmaceuticals, Inc. recalled certain lots of irbesartan, a similar angiotensin receptor blocker used in blood pressure management.

The recalls initially began last summer when FDA recalled a number of lots of valsartan due to an “impurity”, N-nitrosodimethylamine (NDMA) that is known to cause cancer in animals.  Weeks later they additionally found traces of N-nitrosodiethylamine (NDEA).

According to Reuters, earlier last summer, the MHRA, Medicines and Healthcare Products Regulatory Agency, located in the UK, said the appearance of the impurity, N-nitrosodimethylamine (NDMA), came after a change in the process for making valsartan at one facility owned by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

In animals, NDMA is known to cause liver and lung cancer.  In humans its carcinogenic risk is unknown, however the CDC states it may cause liver function impairment and cirrhosis.

With NDEA, data is limited, but due to its classification as a nitrosamine and its prevalence in tobacco smoke it is classified as a probable human carcinogen.

According to New Jersey Department of Health’s website, NDEA has been linked to liver, lung and gastrointestinal tract cancer in animals.

Losartan, valsartan and irbesartan are medications in the class of angiotensin receptor blockers (ARBs) used for high blood pressure and congestive heart failure.

Those taking either tablet for their blood pressure are urged to not abruptly stop their medication but rather check with their medical provider and pharmacy to see if their particular prescription is involved in the recall.

I suspect more recalls will follow as processes may be similar across multiple pharmaceutical facilities and NMBA, NDMA and NDEA are byproducts that may not be individually unique to just one “brand” of medication manufacturing.

 

 

IMG_1781

The Baby Boomer’s Guide to Online Dating

Daliah Wachs, MD, FAAFP is a nationally syndicated radio personality on GCN Network, KDWN, and iHeart Radio.

Posted in Health, news, vaping

Vaping May Induce Seizures in Teens

The FDA is investigating 35 reports of seizures in e-cigarette users.

Many were teenagers and young adults.

Since 2010 the agency has received 35 reports but is unclear if e-cigarettes actually caused the seizures or if there were underlying medical conditions predisposing the neurological disorder.

FDA Commissioner Dr. Scott Gottlieb tweeted:

While we’re still learning about the long-term potential benefits and health risks of e-cigs, existing scientific research offers some clear evidence that several of the dangerous chemicals in tobacco smoke are also present in the aerosol of some e-cig products.

What is a seizure?

A seizure occurs when there is abnormal electrical activity in the brain.  If the electricity doesn’t conduct properly, brain function gets disrupted. This could lead to convulsions  (involuntary jerking movements), loss of muscle tone, changes in senses such as vision, hearing and smell, loss of bladder control, loss of consciousness and sometimes stroke, brain damage and death.

HGT0066_neurons-seizure-brain_FS.jpg

 

Nicotine toxicity has been linked to seizures.  E-cigs sometimes contain more nicotine than cigarettes alone.

 

_________________________________________________________________________________________

A study published by the American Heart Association found nine different E-cig flavors  to impair blood vessel function, which can impair heart health.

Endothelial cells, which delicately line blood and lymph vessels, were found to become inflamed at low concentrations of some vapor flavors.  And at high concentrations of others, exibited cell death.  Nitric oxide production, necessary for vessel dilation to improve blood flow, was impaired as well. These are often the same changes seen in early heart disease.

sample_01001118_110141.jpg

The 9 flavors (and the chemicals within) cited in the report to cause the endothelial inflammation and/or damage were:

  • Mint (menthol)
  • Vanilla (vanillin)
  • Clove (eugenol)
  • Cinnamon (cinnamaldehyde)
  • Strawberry (dimethylpyrazine)
  • Banana (isoamyl acetate)
  • Butter (diacetyl)
  • Eucalyptus/spicy cooling (eucalyptol)
  • Burnt flavor (acetylpyridine)

Strawberry flavoring appeared to have the most adverse effect on the cells.

Now many other flavors were not included in this study, so its unknown how safe they may be.

For more on the study, read here.

An alternate study published last November looked at vaping flavors and their effects on heart muscle cells.

For more on this study, read here.

The moral?  Just because we love the taste of something, doesn’t mean its safe to inhale.

___________________________________________________________________

Vaping Linked to Heart Disease and Cancer

 

A study from New York University found the nicotine in electronic cigarettes to cause DNA damage similar to cigarette smoking.

Dr. Moon-shong Tang and his colleagues exposed mice to e-cig smoke during a three-month period, 5 days a week for three hours a day.  They found these mice, compared to those breathing filtered air, to have DNA damage to cells in their bladders, lungs and hearts. The amount of nicotine inhaled was approximately 10mg/ml.   That dose would be commonly consumed by many humans who vape.

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They then looked at human bladder and lung cells and found tumor cells were able to grow more easily once exposed to nicotine and vaping chemicals.

Last May, researchers from Vanderbilt-Ingram Cancer Center in Nashville found e-cig smoke to increase one’s risk of bladder cancer.

In 2015, the University of Minnesota identified chemicals commonly found in e-cig vapor to include:

  • Formaldehyde (human carcinogen)
  • Acetaldehyde (carcinogen related to alcohol drinking)
  • Acrolein (highly irritating and toxic)
  • Toluene (toxic) NNN, NNK (tobacco carcinogens related to nicotine)
  • Metals (possible carcinogens and toxins)

Although electronic cigarette “juice” may appear safe, it could produce harmful chemicals once heated to become a vapor.

A lethal dose of nicotine for an adult ranges from 30-60 mg and varied for children (0.5-1.0 mg/kg can be a lethal dosage for adults, and 0.1 mg/kg for children).  E-cigs, depending on their strengths (0 – 5.4%) could contain up to 54 mg of nicotine per cartridge (a 1.8% e -cig would contain 18mg/ml).

The topic of nicotine increasing one’s vulnerability to cancer is nothing new as decades ago researchers found nicotine to affect the cilia (brush border) along the respiratory tree, preventing mucous production and a sweeping out of carcinogens trying to make their way down to the lungs.

More research needs to be performed but this recent report reminds us that exposing our delicate lung tissue and immune system to vaping chemicals may not be as safe as we think.

For more on the study read here.

Toxic metals found in vaping liquid

In February, one study reported that toxic levels of lead and other metals may leak from the heating coil element into the vapor inhaled during e-cig use.

Researchers at Johns Hopkins Bloomberg School of Public Health found these metals to include:

  • lead
  • nickel
  • manganese
  • chromium
  • arsenic

We’ve known for some time that vaping fluid could contain chemicals that turn toxic once heated, but this study shed light on e-cig metal components causing metal leakage to the vapor making contact with delicate respiratory epithelium (lining).

Reported by Forbes, Rich Able, a medical device marketing consultant, stated the following, “the FDA does not currently test any of the most popular vaping and e-cigarette instruments being manufactured at unregulated factories in Asia that source  low-grade parts, batteries, and materials for the production of these devices,” suggesting that “the metal and parts composition of these devices must be stringently tested for toxic analytes and corrosive compounds.”

These chemicals may act as neurotoxins, affecting our nervous system, cause tissue necrosis (cell death) and even multi-organ failure.  Moreover they can affect how our immune system reacts to other chemicals as well as foreign pathogens, affecting our ability to fight other diseases.

Although studies have suggested e-cig vapor to be safer than tobacco smoke, not enough research has been done, in the relatively few years vaping has been around, looking at how heat-transformed chemicals and leaked metals affect our breathing, lungs and other organs once absorbed into the body.

Twitter @DrDaliah

Daliah Wachs, MD, FAAFP is a nationally syndicated radio personality on GCN Network, iHeart Radio and Board Certified Family Physician