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

On Friday, April 12th, Fisher-Price voluntarily recalled the “Fisher-Price Rock ‘n Play Sleeper,” after the U.S. Consumer Product Safety Commission (CPSC) discovered more than 30 babies have died while in the rocker since 2009 - 10 of them occurring since 2015. The CPSC said anyone who purchased the Rock ‘n Play should immediately cease using it and contact Fisher-Price for a refund. The American Academy of Pediatrics agreed with the findings of the CPSC calling the sleepers “deadly,” and urged Fisher-Price for the recall as well.

 

No one is specifying exactly how the babies died, but some were from "suffocation" and most seem to have occurred after an infant "rolled from their back to their stomach," presumably causing the cradle to tip and the child to fall. A week ago Fisher-Price looked into the infant death report from the CPSC, and issued a warning about the product in question, saying:

 

“Fisher-Price warns consumers to stop using the product when infants can roll over, but the reported deaths show that some consumers are still using the product when infants are capable of rolling and without using the three point harness restraint…”

 

In other words - read instructions and don’t use a product for something it is not designed for - because that might be unsafe. Okay. Fair enough. But, that’s clearly “covering our own ass” speech. It’s not like parents were doing something completely unreasonable with the product. The Rock ‘n Play is a soft cradle that vibrates and it’s sole design purpose is to help babies fall asleep, and parents are using the rocker to do exactly that. And, at least 32 times that the investigation has (so far) uncovered - a parent’s reasonable use of the product resulted in the tragic death of their baby.

 

The recall was the right thing to do.

 

Fisher-Price issued this statement:

 

"A child fatality is an unimaginable tragedy. For almost 90 years, Fisher-Price has made the safety of children our highest priority.

In recent days, questions have been raised about the Fisher-Price Rock 'n Play Sleeper. We stand by the safety of our products. However, due to reported incidents in which the product was used contrary to the safety warnings and instructions, we have decided to conduct a voluntary recall of the Rock ‘n Play Sleeper in partnership with the Consumer Product Safety Commission.

Fisher-Price has a long, proud tradition of prioritizing safety as our mission. We at Fisher-Price want parents around the world to know that we have every intention of continuing that tradition.

Chuck Scothon, GM, Fisher-Price"

 

For more information about the recall, customers can contact Fisher-Price at www.service.mattel.com and click on "Recalls & Safety Alerts," or at 866-812-6518 from 9:00 a.m. to 6:00 p.m. ET - Monday through Friday.

Published in News & Information