Items filtered by date: Thursday, 25 April 2019

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). NMBA, according to Toronto Research Chemicals, is a known carcinogen in a wide range of animal species. 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.

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.

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, 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 is a guest contributor to GCN news, her views and opinions, medical or otherwise, if expressed, are her own. Doctor Wachs is an MD,  FAAFP and a Board Certified Family Physician.  The Dr. Daliah Show , is nationally syndicated M-F from 11:00 am - 2:00 pm and Saturday from Noon-1:00 pm (all central times) at GCN.

 

 

Published in Health

One joy of studying history, especially the 20th Century, is to see how life has changed. To my great satisfaction, our daughter Karyn has a fondness for the subject and especially the aspect of it that shows how people lived then versus now, particularly as reflected in popular culture.

As some folks know, I still collect sports and non-sports cards. I believe in the adage that he who dies with the most baseball cards, wins.  Such cards and related ephemera are a great reflection of the times when they were produced and a deep insight into the real history and culture of their eras.

Recently, I acquired a reprint set of the first issue of football cards, which included 35 National Football League players and the immortal Knute Rockne, who had coached at Notre Dame and shaped much of the early game.

The original set, produced in 1935 by the National Chicle Co. of Cambridge MA is too expensive for a non-corrupt former elected official, because it includes the most valuable football card ever, number 34 Bronko Nagurski, as well as number 9 Rockne.  They can command five-figure prices in near-mint condition.  My reproductions, easily distinguished from the real items, cost a few dollars.

Among other things, all the players are pictured in actual football poses, not with fur coats, bling and shades as some stars have been in recent years. The front sides are art, not photographs, and they use very bright colors, attractive compositions and simple designs with football backgrounds.

The text on the back of the cards, written by Eddie Casey, then coach of the Boston Redskins and formerly Harvard, shows how real sports and life were then as compared to today.

A few things really struck me.  The first was the line in Nagurski’s biography on the back that said: “A product of the wheat farm country, he stills works the soil between action on the football field and professional wrestling mat.”  This is a great example of a feature of many cards even into the middle-1950s: the discussion of the player’s off-season job.

Their pay was so modest that many had to hold an off-season job for a decent living.  Quite the opposite of the sometimes multi-million-dollar guaranteed levels even for rookies in some professional leagues now and the long-term contracts with mid-eight-figure annual pay for some stars.

After baseballer Carl Furillo won the National League batting crown in 1953, he returned to his winter job as an elevator repairman for Otis Elevators, according to one of his cards.  Perhaps more than any other fact, that illustrates what I mean about life being real then.

Another item is that the text on the first 27 cards is essentially a tutorial for kids and adults on how to play certain positions and actions, as depicted by the player on the front. From all aspects of kicking, passing, receiving and handling the ball both in the open field and when plunging into the line to the need for defensive ends on kickoffs to stay in their lanes and turn the ball carrier to the middle of the field, etc.

These cards were meant for real fans of the time, not for kids ripping open packs to find a rare insert or special card.

A third aspect of how real everything was then is the height and weight statistics.  Only one of the 35 players tipped the scales above 220 pounds (number 11 Turk Edwards at 250) and none were taller than 6’ 3.”  Some colleges today have all their starting linemen at 300 pounds plus.

Perhaps the most endearing thing is that coach Casey knew his football, as shown in the final text on Nagurski: “He is as much a tradition to [his alma mater] Minnesota football today as Red Grange is to Illinois.”

The text on the next card ends: “Now, reaching the end of his professional career as a player he is following the footsteps of Red Grange in becoming an assistant coach to the bears.”

Illini fans then and now have always known that Grange was the greatest college football player ever.

Now, if only my daughter Karyn would develop a taste for card collecting.

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Ron Knecht is a contributing editor to the Penny Press - the conservative weekly "voice of Nevada." You can subscribe here at www.pennypressnv.com. His column has been reprinted in full, with permission. 

 

Published in Sports

Governor Jimmy Davis must be rolling over in his grave right now. Louisiana’s internationally acclaimed official state song is under attack by the Louisiana Legislature. There is an effort by some south Louisiana legislators to designate the Cajun classic Jambalaya as an official public ballad. And them’s fightin’ words for those who have embraced You are my Sunshine as the sanctioned formal melody.

The Sunshine defenders point out that it could be the most recognized American ballad worldwide. Go to a small Asian community where little or no English is spoken.  Start humming, You Are My Sunshine. More likely than not, the locals will join in singing the song in English.  Everybody knows the words to a down-home tune written by a Louisiana country singer and movie star. And he was sworn in as Louisiana Governor seventy-five years ago this month.

A few years back, I was in Cambodia at the Golden Triangle, where Burma and Thailand converge.  I was having breakfast in a rural village at an outdoor café, and the young waitress who knew a few words in English said, “You American. I love America. I sing about America.”  Then, with a big grin on her face, she broke out in song and danced around the dirt floor singing You Are My Sunshine.

That’s in no way meant to belittle the Cajun tune played in dance halls and musical venues all over Louisiana and much of the south. But there is a vast difference between the two songs.  Sunshine was written and sung by a Louisiana native who happened to end up as governor.  Jambalaya was written by Hank Williams, who was born, raised and is buried in Alabama.  Haven’t we here in the Bayou State been humiliated enough by Alabama football to have to have our state song written by another Roll Tide advocate?

Actually, Jambalaya’s melody is basically the same tune taken from the song Grand Texas, about a lost love; a woman who left the country singer to go with someone else to “Big Texas,” where ever that’s supposed to be.  So we have an Alabama song written off a Texas tune that may end up as the Bayou Nation’s new state song.

And what about some of the Jambalaya lyrics? A line in the song is “For tonight, I’m-a gonna see my ma cher a mi-o.”  OK. I get ma cher. Even us uneducated rednecks know that ma cher means “my dear.”  But what about this a mi-o.  The word doesn’t exist.  I’ve checked slang dictionaries in French and Spanish.  No such word.

Now I’ll admit it’s a bit hard to defend some of the lyrics in Sunshine.  Take the stanzas:

You told me once, dear, you really loved me

And no one else could come between

But now you’ve left me and love another

You have shattered all my dreams

I’ll concede such verbiage doesn’t set the best example for our young folks to aspire to greater heights.  But hey, it’s only a song. Just like the partying words of Jambalaya, I guess it really doesn’t make much of a difference. Outside of a bar or dancehall, when was the last time you heard either song being sung?  So maybe it’s just as well to have two state songs.

Being a redneck and having gotten to know Gov. Jimmie Davis back in the 1970’s, I’m just partial to You are my Sunshine.  And just who was Sunshine?  A past lover? A devoted family member? No. Sunshine was Jimmie Davis’s horse. The palomino mare is buried up on the Davis family farm above my old home of Ferriday. I pass that way occasionally and remember back on my conversations with the Governor.  And yes.  I do hum a few bars of what will always be my favorite Louisiana song, You Are My Sunshine.

 

Peace and Justice

Jim Brown

 

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Jim Brown is a guest contributor to GCN news. His views and opinions, if expressed, are his own. His column appears each week in numerous newspapers throughout the nation and on websites worldwide. You can read all his past columns and see continuing updates at http://www.jimbrownusa.com. You can also hear Jim’s nationally syndicated radio show, Common Sense, each Sunday morning from 9:00 am till 11:00 am Central Time on the Genesis Communication Network.

Published in Opinion