Posted in drugs, Health, medications, news, recall

FDA Orders Zantac and Ranitidine To Be Removed From Store Shelves Immediately

In September, the FDA  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.

Now drugmakers are mandated to pull all Zantac brand name and generic products off the shelves and stop online sales.

Patients are also urged to stop taking any of the products they currently have and discard them immediately following the FDA’s drug disposal guidelines.  Discussions with one’s healthcare provider should be done if consumers need medication alternatives.

Other similar medications in its class such as: famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec), are not believed to have the same risks of NDMA exposure.

We don’t believe there have been reports of consumers becoming ill.  In animals, N-nitrosodimethylamine (NDMA) is known to cause liver and lung cancer.  It has been linked to tumor production in a variety of human organs, including the tongue, esophagus, lung, pancreas, liver, kidney and bladder (Ciemniak A., 2006). Additionally, the CDC states it may cause liver function impairment and cirrhosis.

The FDA writes:

The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

Hence the FDA believes unsafe levels of NDMA could exist in the medications if the product was stored in higher than normal room temperatures.

They also state:

NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans. The FDA conducted thorough laboratory tests and found NDMA in ranitidine at low levels. At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines, and continued its investigation and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.

New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

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 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.

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

The recalls initially began in 2018 when the 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 that year, 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.

 

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

Posted in allergies, coronavirus, Covid-19, flu, Health, medications, news

How to Quell Your Cough

Whether it’s a cold, flu, allergies or coronavirus, many of us might be facing a bout of coughing.

Alcohol and narcotics are not recommended to cure your cough and the FDA has urged children under 2 years of age to not be given any kind of cough and cold product that contains a decongestant or antihistamine.

So if you or your child cannot get rid of a cough, what can you do?  Here’s the breakdown…..

coughmedicineWEB

Why do we cough?

Coughs are actually a brilliant defense mechanism designed to spew out unwanted irritants that make it to our respiratory tree. Its lining has sensory neurons, that when triggered, tell the brain to induce a mechanism that will help clear the airway.  This can, simplistically stated, include a cough but also immune cells mobilized to fight possible infection or heal inflammation.  If the act of mechanically coughing irritates the respiratory tree, you may cough more. Likewise, if inflammatory cells produce excess mucous, this could cause a cycle of continued coughing.

What causes a cough?

We’re well aware that infections caused by virusesbacteria and fungi can cause coughs. But the following need to also be considered.

  • GERD – Gastroesophageal reflux disease – the acid that is refluxing out of the stomach and into the esophagus can, while lying down sleeping, makes its way up into the respiratory tree, irritating the lungs
  • Medications – such as ACE inhibitors used for high blood pressure – cause accumulation of bradykinin which can induce coughing
  • Pollution – including dust, pollen, and smoke
  • Chemicals – such as household products who’s aerosol irritate the lung lining
  • Mold spores
  • Cold weather
  • Exercise
  • Allergies 
  • Post nasal drip
  • Lung conditions – such as asthma, sarcoidosis, emphysema
  • Heart conditions – such a heart failure
  • Tumors
  • Psychological coughing – such as a tic

and more……

What can cure a cough?

We don’t actually “cure” the cough, because remember, it’s a well received defense mechanism.  But to control the cough requires us knowing why you’re coughing in the first place.

If one has pneumoniaantibiotics will be needed to kill the bacteria causing the lung infection.

If one has GERDmedications that decrease acid production and secretion may be required.

If its due to allergiesavoidance of the allergen and medications such as antihistamines, or corticosteroids might be utilized.

If it’s a tumor, then surgery, radiation and/or chemotherapy may be necessary.

But for the common viral nagging cough that many of us are dealing with this season, here is what we recommend:

Steam

Whether its holding your head over a pot on the stove, humidifier, vaporizer or steam shower, the cough reflex subsides and the moisture helps decrease inflammation.

Stay hydrated

Mucous thickens when water content is low, so loosening it up with hydration will make it less irritating.  A dry throat doesn’t do us any good either so keep your fluids up.

Honey

Studies have found this to be an effective cough suppressant. Add it to some warm water, lemon juice or tea and your throat will be soothed as well. Avoid in children under one year of age.

Cough drops

Menthol cough drops work by causing a local anesthetic effect on the back of the throat, temporarily decreasing irritation.

Cough suppressants and expectorants

Decrease the cough reflex and thin the mucous respectively.  One, however, should not self treat using these chronically without having their cough evaluated first.

Natural remedies

Natural remedies (without much scientific evidence) such as Peppermint, Thyme, Eucalyptus, Licorice, Ginger may also provide some relief.

Chocolate

Yes chocolate.  This yummy treat has theobromine, which can suppress cough, and a study in late 2015 found it to work better than codeine.

 

What about alcohol and narcotics for cough?

These are not medically recommended, however, many people choose to self-medicate with alcohol and pain pills to control their cough.  Here’s why. Older cough syrups used to contain alcohol, as alcohol may dry up mucous, and induce sleep which may lessen the cough.  Narcotics decrease respiratory drive and provide analgesia which also decreases the cough reflex.  But alcohol is a no no as it can increase acid reflux, worsening cough, and narcotics are a bad idea as they decrease respiratory drive.  However, many prescription cough medications do include codeine and are used when the cough is severe.  However, the FDA does not recommend use of opioid containing cough medicine in those under the age of 18.

 

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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, disease, Health, medications, news

Insulin and Other Medications Being Sold Online Illegally on Craigslist

As drug prices keep rising, patients are turning to unconventional routes to purchase their medication.  However, those who sell and distribute medications without a license are doing it illegally….and putting the buyer at risk.

A new study in JAMA looked at the illegal sales of drugs such as insulin, albuterol, and epinephrine (EpiPen) and found multiple ads placed during a 12 day period in June 2019 on Craigslist.  The medications that treat diabetes, asthma and anaphylaxis respectively are life saving medications which have unfortunately skyrocketed in price over the last 10 years.

Craigslist is a popular website that allows millions of people to post classified ads, ranging anywhere from job opportunities, to services, to goods and products, to items wanted.

Study authors write:

Reports in the lay press suggest that patients who cannot afford prescription medications seek out discounted products in online marketplaces such as Craigslist.1 The unregulated sale and purchase of prescription medication is prohibited by law and Craigslist policy.24

Many of the drugs sold could be surplus, as the seller may have had a recent medication switch by their provider.  Others may have been prescriptions obtained and sold for a profit.

Study authors found the albuterol, asthma inhalers to be sold higher than prescription cost, but many of the insulin products were at a discount.

Sellers can get away with the higher prices as buyers may feel the are saving money overall by not going into a medical clinic to obtain the prescription.

 

albuterol online

However, medications not sold by a pharmacy could carry risks.  If opened they could be contaminated.  If it’s an insulin product, the pen or vial needs to be refrigerated before use, or in a climate that doesn’t exceed room temperature depending on the manufacturer’s warning.   One cannot assume the storage and distribution of the medication was done properly.

 

insulin online 2

Hence if a buyer is an insulin dependent diabetic they may be purchasing less than optimal potency of their life saving medication. The same holds true with an albuterol inhaler used during as asthmatic attack or an EpiPen used during severe allergic reactions.

Medical providers are urging patients to not seek discounted products online when it comes to their disease management but instead to reach out to them or the pharmacy for generic alternatives and pharmaceutical company discounts.

 

 

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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.

Posted in cancer, disease, Health, medications, news

California to Decide if Acetaminophen Products Need “Cancer Risk” Label

In compliance with Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, California may have to enforce retailers to label acetaminophen-containing products as having potential “cancer risk.”

Proposition 65 requires the state to maintain a list of chemicals that can cause cancer, birth defects or reproductive harm. Businesses must also provide warnings if their products sold contain compounds included on the list.  If they don’t, they can be subject to a $2500 fine per violation per day.

There are over 900 chemicals currently on the list of toxic substances, and state regulators reviewed 133 studies to see if acetaminophen needs to be included.

Although acetaminophen use has been linked to liver disease (see below), and pediatric asthma, autism and ADHD if exposed perinatally, cancer studies have been far and few between.

However, in 2011, a study published in the Journal of Clinical Oncology, found “high use of acetaminophen was associated with an almost two-fold increased risk of incident hematological malignancies” such as myeloid neoplasms, non-Hodgkin lymphoma and plasma cell disorders.  By “high use” they described taking acetaminophen more than 4 times a week for over 4 years.  The cancer risk was still deemed as rare, but statistically significant.

A designation of being included in the Proposition 65 “list” is controversial as its hopes of educating the public could cause fear in the use of a medication has has been deemed relatively safe as opposed to other products used for similar illnesses (i.e. using acetaminophen for pain relief instead of an opioid), while at the same time open companies up to lawsuits if one alleges their medical condition came from an acetaminophen-containing product.

TYLENOL® poisoning, more common than we think

Acetaminophen (paracetamol in Europe) has long been known to cause liver failure. But now researchers reveal why its the number one cause of acute liver failure.  And even more troubling, many people don’t realize they are overdosing on this common medication.

What does the liver do?

The liver filters and detoxifies blood.  Additionally it breaks down and stores cholesterol and lipids and produces proteins. The liver also produces bile that gets stored in the gall bladder to help digest food after eating.  It is one of the few organs in the body that can regenerate itself when tissue is damaged.  So its troubled scientists how drug toxicity could irreversibly damage the liver to the same degree hepatitis, cirrhosis and cancer do.   Researchers from the University of Edinburgh studied human and mouse liver cells and now know why.

What is liver failure?

In order for the liver cell to work, it needs to work in concert with the cells surrounding it but work in separate groupings, each with a different function.  Excessive acetaminophen (the main ingredient in Tylenol) disrupts these cell connections, called “tight junctions”, hence the cells don’t function properly.  “Failure” of an organ, such as “liver failure”, “heart failure”, and “renal failure” occur when the cells of the organ aren’t healthy enough to allow the organ to function.

Signs and symptoms of liver failure include:  jaundice (yellow color to skin and eyes), fatigue, weakness, easy bleeding, nausea, diarrhea, confusion to name a few.

Knowing the mechanism of injury to the hepatocytes, liver cells, may allow scientists to create a means to repair liver cells that can’t be repaired themselves.  Or design a pain reliever that doesn’t damage the liver.

How much acetaminophen is toxic?

Taking more than 4 grams a day could be considered and “overdose” and toxic.  Frighteningly, this level is commonly consumed on a daily basis.  Over the counter an “extra strength” dose contains 500 mg of acetaminophen.  So if a person takes 1-2 pills every 4-6 hours, they can easily take 4 grams a day. Add a pain medication such as Vicodin or Percocet which contain acetaminophen, or a cough and cold remedy, or even an over the counter sleeping aid which may contain it as well, and its no surprise so many end up in the emergency room.

The following is a list of over the counter medications that may contain acetaminophen (provided by knowyourdose.org)

Some Common Over-the-Counter Brand Name Drugs That Contain Acetaminophen

Actifed®
Alka-Seltzer Plus®
Anacin®
Cepacol®
Contac®
Coricidin®
Dayquil®
Dimetapp®
Dristan®
Excedrin®
Feverall®
Formula 44®
Goody’s® Powders
Liquiprin®
Midol®
Mucinex®
Nyquil®
Panadol®
Robitussin®
Saint Joseph® Aspirin-Free
Singlet®
Sinutab®
Sudafed®
Theraflu®
Triaminic®
TYLENOL® Brand Products
Vanquish®
Vicks®
*And store brands

Some Common Prescription Drugs That Contain Acetaminophen (or APAP)

Butalbital®
Endocet®
Fioricet®
Hycotab®
Hydrocet®
Hydrocodone Bitartrate®
Lortab®
MIDRIN®
NORCO®
Oxycodone®
Percocet®
Phenaphen®
ROXICET ™
Sedapap®
Tapanol®
Tramadol
TYLENOL® with Codeine
Tylox®
Ultracet®
Vicodin®
Zydone®
*And generic drugs

 

We recommend discussing all your medication, especially over the counter, with your medical provider, and to not assume just because its available without a prescription, its safe in any dose.

                                                                                                         

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

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.