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.

 

dw sketch.jpg

 

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

Advertisements
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.

 

math2_c016f004.gif

 

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.

 

aneurysm.jpg

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.

 

dw sketch.jpg

 

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.

 

Irbesartan-label-FDA-recall-blue-background

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.

 

dw sketch.jpg

 

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.

 

185808

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.

ace.jpg

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.

 

 

dw sketch.jpg

 

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.

 

7211352f1.jpg

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.

 

dw sketch.jpg

 

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 food, Health, medications, news

Can Heartburn Drugs Raise the Risk of Osteoporosis?

This week a study revealed the use of Proton Pump Inhibitors (PPI’s) can increase the risk of hip fractures in dialysis patients by 20%.

As opposed to being forms of calcium carbonate, such as acid neutralizers such as Tums, or H2 (Histamine H2 Antagonist) blockers such as Pepcid and Zantac, the PPI’s reduce stomach acid production from the start.  They’re sold under the brand names of Prilosec, Prevacid, Protonix and Nexium.  They’re popularity has been skyrocketing over the last two decades and have become a mainstay treatment for multiple gastrointestinal issues including ulcers.

Researchers from Baylor College of Medicine found in their study, 75% of dialysis patients who suffered a hip fracture, took a PPI within the preceding three years.

Researchers have long debated if PPI’s can cause osteoporosis or thinning of the bones.

A Canadian study done in 2008 found 7 years of proton pump inhibitor use to raise the risk of osteoporosis-related fractures of the hip, wrist and spine.

Anderson et al wrote in the July 2016 issue of Current Opinion in Rheumatology stated the following:

The use of PPIs is a risk factor for development of osteoporosis and osteoporotic fractures. However, as the direct pathogenesis remains unclear, specific points of intervention are lacking, other than being vigilant in regard to the indication for prescribing PPIs and to use the lowest effective dose where PPIs cannot be avoided.

 

Foods that cause reflux

Gastroesophageal reflux disease can be caused by foods difficult to digest such as processed foods, sugars, and those with refined carbohydrates.

acid-reflux-1-1100x700

 

Foods that help relieve acid reflux

The following may help relieve acid reflux symptoms:

  • Oatmeal
  • Banana
  • Salad
  • Aloe vera
  • Parsley
  • Celery
  • Couscous
  • Rice
  • Lean turkey and chicken

 

Here’s another chart that shows foods that may help or trigger reflux:

reflux foods

Elevating the bed 45 degrees at night helps reduce reflux symptoms.

Avoiding drinking lots of water before sleep helps as well.

Eating smaller meals and avoiding a large dinner at bedtime will decrease acid reflux.

Heartburn Medication Found to Double Risk of Stomach Cancer

So why take medication at all?

Those suffering from GERD can be prone to esophageal cancer if the stomach acid bombarding the lower esophagus fails to be subdued.  Acid reflux can also cause chronic sore throat and chronic cough.  For these reasons, PPIs will still be recommended for severe reflux cases, but maybe lower doses and combinations with other drugs and lifestyle changes should be started first.

 

 

dw sketch.jpg

 

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

Second Possible Carcinogen Found in Recalled Blood Pressure Medication

Regulators are investigating a second possible carcinogen in three lots of a common blood pressure drug.

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.  Now they are concerned, having additionally found traces of N-nitrosodiethylamine (NDEA).

Although originally manufactured and patented by Norvatis Pharmaceuticals, trade name Diovan, the recall involves multiple generic versions of the drug.  Batches made from Zhejiang Huahai Pharmaceuticals, Teva Pharmaceuticals, AvKARE, Torrent, Northwind,  Solco Healthcare and Proficient Rx LP are included in the recall.

The comprehensive list of recalled medications can be found here.

According to Reuters, 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.

The director of FDA’s Center for Drug Evaluation and Research states, “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients.”

Doris Stenved, the chief physician at the Danish Medicines Agency, told the DR Nyheder, “There is no acute health threat to patients, but we know from trials with animals that it can cause cancer.”  She continues, “We don’t know if it has the same effect on humans, we just know it’s a substance that should not be in the medicine.”

Now a recent study published in the BMJ reports no short term cancer risk with NDMA. However it did not comment on long term cancer risk.  Dr. Kasper Kristensen of the University of Southern Denmark states, “We found no evidence of an increase in short-term risk of cancer from exposure to NDMA-contaminated valsartan products in this study of all adult valsartan users in Denmark.”

Valsartan is a medication in the class of angiotensin receptor blockers (ARBs) used for high blood pressure and congestive heart failure.

Although the recall was initially, Europe-wide, it has extended to the US and Americans should check with their pharmacist and/or medical provider to ensure their tablets are not included.

ucm613521.jpg

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

Like N-Nitrosodimethylamine (NDMA), which was found in the recalled valsartan products, NDEA is also formed from a specific sequence of manufacturing steps and chemical reactions. In addition to the FDA’s testing, the agency will post a preliminary method for detecting NDEA. Manufacturers and global regulators can use this method to screen other products for the potential presence of this impurity.

Additionally, the agency will update the list of products included in the recall and the list of products not included in the recall as products are tested for NDEA and as more information becomes available. If you are taking a valsartan product, be sure to check the lists, as they may change.

The FDA reminds patients taking valsartan from a recalled lot to continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. Any patient taking valsartan from a recalled lot who has not yet spoken to their pharmacist or doctor should do so promptly. At this time, the FDA’s testing supports the conclusion that not all valsartan products contain NDMA or NDEA, so pharmacists may be able to provide a valsartan medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

 

dw sketch.jpg

 

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