Posted in Beauty, Health, medications, news, sex

Testosterone Therapy: New Guidelines Released

Millions of men take testosterone supplements each year in the U.S.  Low testosterone, or “Low T”, can manifest in a variety of symptoms including:

  • fatigue
  • erectile dysfunction
  • depression
  • lack of sex drive
  • muscle loss
  • loss of strength
  • decrease muscle strength
  • loss of fertility
  • osteoporosis (decrease bone mass)
  • and may contribute to many other issues.

 

testosterone

The most popular forms of testosterone are injections and gels. Pill forms are available but are not as effective.

Testosterone slowly decreases with age at a rate of 1.6 % per year beginning in one’s 30’s. A man with significant testosterone loss, however could  signify a more serious health issue such as diabetes.  So many physicians don’t hesitate when it comes to supplementing this vital hormone.

However, its not without its risks.   Risks of testosterone therapy include:

  • Increasing risk of prostate size
  • risk of prostate cancer
  • polycythemia (increase red blood cell levels)
  • mood issues
  • sleep apnea
  • acne
  • and multiple studies have found it increases risk of heart attacks and stroke.

 

This week the American College of Physicians released new guidelines on testosterone replacement.

They suggest to only use testosterone therapy when treating sexual dysfunction but not for the other aforementioned conditions as the evidence is not supportive.

Recommendation 1a:

ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence). The discussion should include the potential benefits, harms, costs, and patient’s preferences.

Recommendation 1b:

ACP suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter. Clinicians should discontinue testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function (conditional recommendation; low-certainty evidence).

Recommendation 1c:

ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar.

Recommendation 2:

ACP suggests that clinicians not initiate testosterone treatment in men with age-related low testosterone to improve energy, vitality, physical function, or cognition (conditional recommendation; low-certainty evidence).

They also prefer intramuscular forms over transdermal preparations due to cost.

Testosterone therapy linked to blood clots

In 2016 researchers found a 63% increase risk of blood clots within the first 6 months of testosterone therapy.  These are deadly as they increase risk of heart disease, stroke, pulmonary embolism and organ damage.  They form in veins, deep veins, and thus have an obstructed path to reach vital organs and prevent blood flow.  This is not the first time venous thromboembolism (VTE) has been linked to testosterone therapy. Back in 2014 the FDA recommended warning labels on testosterone products.

According to researchers at Icahn School of Medicine at Mount Sinai in New York City state the overall risk is still low, one case per 1000 men a year, but could be of huge concern for those at risk of blood clots.  Lead researcher, Dr.Carlos Martinez, states, “Risk peaks rapidly in the first six months of treatment and lasts for about nine months, and fades gradually thereafter.” So a promising finding is the risk falls as time passes since therapy.

  • Risk factors for VTE include:
  • genetic predisposition
  • prior blood clots
  • cancer
  • prolonged immobility (long flights, hospitalization stays)
  • pregnancy (women)
  • smoking
  • and of course risk increases with age.

Study author Dr. Mark Creager states, “My advice is to review the patient’s underlying risk factors for VTE, and weigh that risk against the potential benefit of testosterone therapy,” Creager said. “These individuals should at least be made aware of the fact that their risk would be even higher with testosterone.”

This study was published online 11/30/2016 in the BMJ (British Medical Journal)

 

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

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

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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, medications, news, sex

Common Psychiatric Medication May Interfere with Ejaculation

Sexual dysfunction caused by mood stabilizing medications is nothing new.  Patients have complained of loss of sex drive, inability to start or maintain erections and issues with ejaculation.

A case study out of England this week discusses a 25 year old inmate who was taking quetiapine (Brand name Seroquel) when he acquired an inability to ejaculate during masturbation, with semen back-flowing into his bladder (retrograde ejaculation). This type of “dry orgasm” has been documented in previous studies and occurs when a medication, or neurological disorder, causes weakness of the bladder neck allowing semen to make a wrong turn.

Image result for retrograde ejaculation

Quetiapine is in the class of “atypical antipsychotics” and has been used for schizophrenia, bipolar disorder, mania, depression and poor sleep.

The medication can be very effective, however, a side effect such as the aforementioned could lead to lack of compliance.

Most function is restored when the medication is switched to a different one, and in the above case, symptoms improved with the use of the antidepressant imipramine.  However, some patients may be reluctant to continue treatment and more research needs to be done on side effects and their antidotes to improve compliance for those who struggle with mental health and need pharmaceutical intervention.

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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, medications, news

Experts Warn Against Taking Aspirin When Not Recommended by Provider

Harvard researchers warn that 30 million Americans are taking aspirin for prevention of heart disease when they could be putting themselves at risk for other serious diseases.

They estimate that 1/5 of these individuals took aspirin on their own without a doctor’s order.

Although aspirin use is recommended for secondary prevention of future heart attacks and ischemic stroke in those at risk of having a future episode, primary prevention (in those who have never had an attack) is still debated.

One study last year found minimal benefit if at all for primary prevention in low risk individuals.  Many experts say the risk of gastrointestinal bleed, heart disease, hemorrhagic stroke and kidney disease outweigh the benefits.

The latest guidelines from the American College of Cardiology states the following in terms of aspirin for prevention of heart disease:

For decades, low-dose aspirin (75-100 mg with US 81 mg/day) has been widely administered for ASCVD prevention. By irreversibly inhibiting platelet function, aspirin reduces risk of atherothrombosis but at the risk of bleeding, particularly in the gastrointestinal (GI) tract. Aspirin is well established for secondary prevention of ASCVD and is widely recommended for this indication, but recent studies have shown that in the modern era, aspirin should not be used in the routine primary prevention of ASCVD due to lack of net benefit. Most important is to avoid aspirin in persons with increased risk of bleeding including a history of GI bleeding or peptic ulcer disease, bleeding from other sites, age >70 years, thrombocytopenia, coagulopathy, chronic kidney disease, and concurrent use of nonsteroidal anti-inflammatory drugs, steroids, and anticoagulants. The following are recommendations based on meta-analysis and three recent trials:
  • Low-dose aspirin might be considered for primary prevention of ASCVD in select higher ASCVD adults aged 40-70 years who are not at increased bleeding risk.
  • Low-dose aspirin should not be administered on a routine basis for primary prevention of ASCVD among adults >70 years.
  • Low-dose aspirin should not be administered for primary prevention among adults at any age who are at increased bleeding risk.

___________________________

A report published in the American Heart Association’s Heart and Stroke Statistics annual report cite 48% of US adults have some type of cardiovascular disease.

The uptick could be due to rising obesity, and lowering thresholds for diagnosing guidelines such as high blood pressure (now considered high if over 130/80).

Although smoking rates have declined over the years, many still use tobacco and recent research has found E-cigs to increase risk of heart attack and stroke by 70%.

 

What is a stroke?

A stroke occurs when an area of the brain does not get the proper oxygen and blood flow it needs. There are two major types of stroke:  ischemic and hemorrhagic.

Ischemic strokes are more common than the latter and occur when a clot prevents blood flow to part of the brain.  80% of all strokes fall under ischemic.  It is a likened to a heart attack, except the brain tissue is being deprived of blood and nutrients.  Plaques commonly arise from arteriosclerosis that break off travel to the smaller vessels of the brain.

Hemorrhagic strokes are less common and occur when there is a bleed of one of the brain vessels.  The bleed prevents blood flow into the brain since it is seeping outside the brain tissue, causing damage to nearby cells.  The bleeds could occur from high blood pressure or aneurysms that rupture.

 

What are the signs of a stroke?

Since a clot or bleed usually affect one area of the brain, we see symptoms on one side of the body, many times its contralateral (opposite) side.  We can also see central effects.  The symptoms of stroke include the following:

  • Weakness of one side of the body
  • Loss of balance
  • Numbness on one side of the body
  • Slurred speech
  • Vision issues
  • Headache
  • Facial droop

and more…..

 

How are strokes treated?

If the stroke was caused by a clot (ischemic) immediate treatment includes dissolving/removing the clot.   Aspirin is used initially and if within the proper time frame, tissue plasminogen activator (TPA).  These clots can also be surgically removed and arteries widened to bring blood flow to the brain.

With a hemorrhagic  stroke, we need to stop the bleed and improve flow to the brain.  Controlling the bleed, bypassing the vessel, “clogging” the aneurysm with techniques such as “coiling” (endovascular embolization) are sometimes utilized.

Time is of the essence, so its crucial to identify the warning signs and call 911 immediately.  The American Stroke Association uses the acronym “FAST” (Facial drooping, Arm weakness, Speech difficulty, and Time to call 911).  The sooner a stroke victim receives medical attention the better the prognosis.

 

fast

COURTESY OF THE AMERICAN STROKE ASSOCIATION

 

What are the risk factors for stroke?

The following put us at risk of having a stroke.

  • High blood pressure
  • Family history of stroke
  • Diabetes
  • Cardiovascular disease (artery clogging, such as the heart and carotid arteries)
  • Abnormal heart rhythms, such as atrial fibrillation
  • Smoking
  • Drugs
  • Obesity
  • Inactivity
  • Clotting disorder
  • Sleep apnea
  • Being older (greater than 55)
  • African-Americans appear to be more at risk than Caucasians and Hispanics
  • Men seem to be more affected than women

 

How do we prevent strokes?

Avoid the following:

  • Excessive drinking
  • Drug use
  • Tobacco products
  • Control blood pressure, sugar and cholesterol
  • Get evaluated by a medical provider if at risk for heart disease or stroke.

 

Preventing Heart Disease

Firstly, we must know our risk factors. These include:

  • Family history of heart disease
  • Personal history of heart disease
  • High Blood Pressure
  • High Cholesterol
  • Diabetes
  • Smoking
  • Obesity
  • Inactivity
  • Males over 40
  • Females who are post menopausal
  • High stress

and even short stature has been cited as a potential risk factor.

As you can see, many of us can be at risk for heart disease.  Therefore secondly, we should be evaluated with an EKG, echocardiogram and any other exams our medical provider and/or cardiologist deem necessary.

Thirdly, reduce your risk by the following:

  • Maintain a normal blood pressure
  • Maintain normal blood sugar
  • Maintain normal cholesterol and lipid levels
  • Reduce stress
  • Maintain a balanced diet, rich in potassium-rich foods such as fruits and vegetables
  • Quit smoking
  • Stay active
  • Maintain a healthy weight.

 

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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, 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.

 

 

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

Posted in Health, medications, news

Third Cancer Causing Contaminant Found in Popular Blood Pressure Medication

The FDA is adding more medications to the recall now that a third cancer-causing contaminant has been identified.

N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected resulting in the latest recall 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.

The FDA reports:

Hetero Labs Ltd. in India has announced a recall of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity is a known animal and potential human carcinogen. This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines.
Recent testing of these recalled lots of losartan potassium tablets showed NMBA levels higher than the FDA’s interim acceptable intake limits. The FDA’s evaluation suggests that the nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents.
“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure. That said, any presence of such impurities in drug products is not acceptable. Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products,” said FDA Commissioner Scott Gottlieb, M.D. “Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients. FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in ARB medicines. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA. We’re continuing to share these testing methods with international regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity. We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products. The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future.”

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.