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.

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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.

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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.

 

 

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Posted in Health, medications, news

More Blood Pressure Medications Added to Recall Due to Potential Human Cancer Carcinogen

The FDA is adding more medications to the recall involving a cancer causing contaminant.

Made by Aurobindo, 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are being voluntarily recalled due to an active ingredient testing positive for N-nitrosodiethylamine (NDEA), an impurity known to cause cancer in animals.

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

The FDA globally expanded the recall of valsartan this summer 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 this 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.

Amlodipine is in the class of calcium channel blockers and appears to only be involved in this recall if in combination with the affected valsartan tablets.

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.

On the FDA’s website the following has been posted:

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product.   The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.
Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

 

I suspect more recalls will follow as processes may be similar across multiple pharmaceutical facilities and NDMA and NDEA are byproducts that may not be indivudally 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 antibiotics, Health, medications, news

Popular Antibiotic Linked to Aortic Aneurysms and Dissections: FDA

The FDA has warned that a class of antibiotics commonly used to treat respiratory and urinary tract infections may increase one’s risk of artery tearing, ballooning or rupture.

This week the FDA reported that fluoroquinolones, such as those sold under the name Cipro (ciprofloxacin) and Levaquin (levofloxacin), could be associated with an increase risk of aortic aneurysm or dissection.

 

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In an aortic dissection the blood travels into the tear of a wall of the vessel.  In an aneurysm, the vessel bulges like someone stepping on a water hose.

 

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The FDA’s announcement reads as follows:

[12-20-2018] A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available.  People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.  We are requiring that a new warning about this risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones.

Medical providers are being advised to not prescribe fluoroquinolones in the elderly and those patients with:

  • High blood pressure
  • History of aneurysm
  • Peripheral atherosclerotic vascular diseases
  • Genetic disorders such as Marfan syndrome and Ehlers-Danlos syndrome

Aortic dissections and aneurysms that rupture could cause severe bleeding and loss of circulation to vitals parts of the body, leading to death.

Many with an aneurysm are unaware until it bursts.  A dissection or ruptured aortic aneurysm may be accompanied by sudden onset of severe pain in the chest, back or abdomen.  Moreover one can have weakness, shortness of breath, paralysis and loss of consciousness.

This is a developing story.

 

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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

Second Blood Pressure Medication Recalled Due to Cancer Causing Contaminant

Image above from Medical News Today

Officials with ScieGen Pharmaceuticals, Inc. are recalling certain lots of irbesartan, an angiotensin receptor blocker, due to its possession of an impurity known to cause cancer in animals.

N-nitrosodiethylamine (NDEA) was found in some lots manufactured by Aurobindo Pharma Limited.

The FDA globally expanded the recall of valsartan this summer 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 this 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.

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.

 

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On the FDA’s website the following has been posted:

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC)
To date, Sciegen Pharmaceuticals Inc has not received any reports of adverse events related to this product.

 

I suspect more recalls will follow as processes may be similar across multiple pharmaceutical facilities and NDMA and NDEA are byproducts that may not be indivudally 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.

She is also a Board Certified Family Physician and Assistant Professor at Touro University Nevada

Posted in Health, medications, news

Common Blood Pressure Medication Linked to Lung Cancer

A study, published in the BMJ, finds those who take ACE inhibitors are 14% more likely to develop lung cancer.

The study took place in the UK and studied close to 1 million patients over the time period of 1995-2015 and found the longer one took the blood pressure medication, the higher the risk in developing lung cancer.

Over 100 million adults in the US have high blood pressure, and ACE inhibitors are one of the most popular treatments due to their low-cost and efficacy.

They work by blocking an enzyme in the angiotensin-renin system, resulting in blood vessel relaxation and a lowering of blood pressure.

 

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One side effect, however, may be coughing due to the accumulation of bradykinin, and researchers believe this could be the culprit in the increased risk of lung cancer.

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Common ACE inhibitors include ramipril, captopril, lisinopril and benazepril.

However, since lung cancer is the most common type of cancer, blood pressure is one of the most common types of conditions and ACE inhibitors are one the most commonly used blood pressure medications, the association may be coincidental and not a cause and effect.

More research needs to be done on the long-term use of the medications as uncontrolled blood pressure can link to heart disease, stroke and dementia.

 

 

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

She is also a Board Certified Family Physician and Assistant Professor at Touro University Nevada

Posted in Health, medications, news

Antidepressant Withdrawal Can Be Dangerous

Millions of Americans take “antidepressants” with relatively few side effects.  However, many may incur adverse reactions when they stop taking them.

“Antidepressants” come in many different classes including tricyclic antidepressants (i.e. Elavil), monoamine oxidase inhibitors (Nardil), selective serotonin reuptake inhibitors (Prozac), and even benzodiazepines (Xanax). They work by a variety of different mechanisms ranging from inhibiting the reuptake of a neurotransmitter to inducing relaxation and sleep.

 

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How SSRI’s work

 

“Antidepressants” may enhance and stabilize moods, improve sleep, and decrease anxiety.

However, if one forgets to take their medication, loses their prescription, or runs out, they may be at risk of “Antidepressant Discontinuation Syndrome.”

Symptoms of withdrawal or “discontinuation syndrome” may include:

  • anxiety
  • insomnia
  • restlessness
  • flu-like symptoms
  • nausea
  • vomiting
  • vertigo
  • gastrointestinal issues
  • confusion
  • delirium
  • paresthesias
  • dizziness
  • agitation
  • tremor
  • balance issues
  • rebound depression
  • rebound anxiety
  • seizures
  • and more

And these symptoms can occur within hours of a missed dose.

Hence someone who abruptly stops taking a daily benzodiazepine, such as Xanax or Valium, could undergo a withdrawal seizure and die.  In 2009, Lann et al described a case of a woman who developed seizure-like activity and died within days of discontinuing her benzodiazepine.  “The decedent had abruptly stopped taking the alprazolam approximately 4 days before admission when she ran out of the medication.”

Those abruptly discontinuing their SSRI could be at risk for suicide.  In 2009, Valuk et al stated, “Antidepressant discontinuation showed a significant risk for suicide attempt.”

Hence caution needs to be instilled when taking these medications to ensure one does not run out or has resources and support when trying to wean off.  A slow, methodical discontinuation of an antidepressant can be effectively and safely done when needed.

 

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

She is also a Board Certified Family Physician and Assistant Professor at Touro University Nevada