eddessaknight's Blog

When consumers get a prescription drug from the pharmacy, they assume that it’s been tested and is safe to use. But what if a drug changes in harmful ways as it sits on the shelf or in the body?

One dangerous result has been the creation of N-nitrosodimethylamine (NDMA), a  probable carcinogen, in certain drugs. NDMA is found in chlorinated water, food and drugs in trace amounts. To minimize exposure, the Food and Drug Administration has set an acceptable level of NDMA in each pill at less than  96 nanograms.

But over the past few years the FDA has found excessive amounts of NDMA in several drugs for  hypertension, diabetes and heartburn. As a result, the agency has initiated recalls to protect the public. These products were contaminated with NDMA during the manufacturing process. The FDA recommended best practices for manufacturers to minimize this risk going forward.

Unfortunately for the buying public, emerging evidence suggests that NDMA can also be created as some pills sit on the store shelf or medicine cabinet, or even after the patient swallows it. Thus, there is no way to test for its presence in the factory.

I am a  pharmacist and distinguished professor  who has written extensively about manufacturing issues and FDA oversight associated with both  drugs  and  dietary supplements  in the past, including the issue of  NDMA  contamination. In a new article, I discuss  how NDMA can end up in a patient’s medication  if it wasn’t put there during its manufacture.

NDMA levels creep up after manufacture

Ranitidine (Zantac)  was a commonly used heartburn and ulcer prescription and over-the-counter medication for decades before it was recalled by the FDA on April 1, 2020. It may now be the canary in the coal mine for the post-manufacturing creation of NDMA.

In one study, investigators found that ranitidine contained only 18 nanograms of NDMA after it was manufactured. However, when stored at 158°F for 12 days – as if the drug had been left in a hot car –  NDMA dosages rose above 140 ng. This is only slightly above the 96 ng limit the FDA has deemed safe, but this was only 12 days later.

In another study, storing ranitidine where it was exposed to higher temperatures or high humidity  enhanced the creation of NDMA over time. This suggests that some medications can leave the factory with a safe amount of NDMA but if kept for too long at home or on the store shelf can exceed known acceptable limits by the time patients use them.

In a new study in  JAMA Network Open, investigators simulated the stomach environment and found that when ranitidine was exposed to an acidic environment with a nitrite source, these chemicals could create more than 10,000 ng of NDMA.

These results support a clinical study in which urine samples were collected from 10 adults both before and after using ranitidine. After people swallowed ranitidine, the urinary NDMA doses  rose from about 100 ng to more than 40,000 ng  over the next day.

Other drugs need closer investigation

In another study, investigators added  chloramine, a disinfectant routinely added to sterilize drinking water, to water samples that contained one of several medications that are structurally similar to ranitidine. They found that several commonly used drugs, including antihistamines (doxylamine and chlorpheniramine), a migraine drug (sumatriptan), another heartburn drug (nizatidine) and a blood pressure drug (diltiazem)  all generated NDMA.

It is unclear whether the amount of NDMA created by these drugs when stored in hot and humid environments or after a patient swallows them is dangerous, as with ranitidine. I believe that more studies need to be done right away to find out. It is always better to be safe than sorry, particularly when dealing with a possible carcinogen.

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This article is republished from  The Conversation, a nonprofit news site dedicated to sharing ideas from academic experts. It was written by:  C. Michael White,  University of Connecticut.

Thought of this when I read this incredible story…

It’s about a 90-year-old French woman who lived in a small village near Paris. She had just sold the modest home she’d lived in for over 60 years.

After the papers were signed, she called the local dump so they could come get rid of the contents of the house.

At the last minute though, she had second thoughts and called an expert in to check ‘just in case’ there might be something of value.

Reluctant to come, the busy expert popped in between meetings late one afternoon.

The minute she entered the house, she stopped dead in her tracks.

Her eyes were fixed on a painting hung above the hotplate in the kitchen.

She wasn’t sure… but she had a hunch it might be very valuable.

The painting, a small 8 X 10-inch frameless piece that the family had always assumed was a worthless religious icon picked up at a random flea market, was rushed to Paris for appraisal.

1. Art experts in the French capital quickly confirmed that the painting was indexed a long-lost rare work of Cimabue, one of the artists of the early Italian Renaissance.
2. A few months later, on October 27, 2019, the tiny painting was sold at auction - to an anonymous buyer for a cool $26.6 million.
3. Gold… hidden in plain sight but only in treasure chests.....

4. Treasures include true friends

5. They are everywhere, seen and unseen ~~~~~~~~

Nota Bene:

Often times, while being gifted with possession of powerful non physical treasures within us, and try to tell others of them, seldom are we believed.....💔 

Au Revoir 😊

https://1funny.com/movie-stars-dancing-to-im-so-excited/

Movie stars dancing to…’I’m So Excited!’  I just shared this dancing video with 7 French ladies in their 70’s who I am teaching English conversation. I suggested that singing and dancing to “I’m so excited” will be a perfect warm up for preparing their homework.

 The Beat goes on!