I think it was "dharmabum" who first raised the early alarm about some sort of "recall" going on with a med (that I think she was on), Losartan (perhaps it was some other Losartan formula name she mentioned), but I do believe this Losartan drug was the one she referred to and was concerned about (I looked for but cannot find her post on this) - but, she was rightly concerned, as when I also looked for further articles on this subject - the first and subsequent "news" coming out about this drug and where this drug was manufactured/packaged/assembled ... reported a contamination "problem", and perhaps they had been having this problem for a while. There have been ongoing and evolving reports out about Losartan (and this plant, and other Losartan containing type drugs), and, perhaps other drugs (not losartan) that were also from this plant - that they found to be containing some (possibly multiple?) contaminants - main concern seemed to be trace amounts of some kind of possibly carcinogenic rocket fuel contaminant!! Talk about a BP med with a boost to it.
Bad for profits to have this drug (and other formulas) pulled/held/suspect. Patients and docs who otherwise found the drug good for their BP's, were now inconvenienced, worried, not taking/using the drug. Contaminates and shortages are not good for anyone.
Interesting how FDA has "weighed the risks" and are now letting the drug be doled out, with the contaminant problem "soon" (maybe 6 months?) to be fixed? Um, how long may the drug have been contaminated before it was found to be so, and how long have people already been taking this drug in the contaminated version - does taking it in the "minutely" contaminated form for another 6 months make any dif? I heard a nice lady once, called Rosalie Bertell, say there was no such thing as "just a little bit" of poison being OK, like arsenic?, that was her example, Rosalie said our bodies were simply not built for it - that the correct amount our bodies should ingest was zero, zilch, nil, nada.
Being that "Michaele" brought this BP med subject up today - i thought i would post this late article. It was interesting the 2009 study that Michaele found and mentioned today (about losartan and fibrosis reduction) but there were very few people in the study back then. Another study was started in 2018, kind of on the same theory, but it went no where, as it's sample size was also small (way too small). So, the question is still out there - does losartan have an effect on reducing fibrosis as well as affecting your BP, and is there such a thing as a losartan deluxe where you get a side of rocket fuel with that?
News > Medscape Medical News > News Alerts
FDA Permits Temporary Distribution of Tainted Losartan
Megan Brooks
DISCLOSURES
March 21, 2019
Amid an ongoing series of tainted sartan drug recalls, the US Food and Drug Administration (FDA) announced Wednesday that it will not object to temporary distribution of losartan that contains the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until it can be eliminated.
The goal is to ensure continued access, the FDA said. The agency expects many companies will be able to make losartan without nitrosamine impurities and replenish the US supply in about 6 months.
Scientists at FDA evaluated the risk of exposure to NMBA at levels up to 9.82 ppm and found that it presents "no meaningful difference" in cancer risk over 6 months compared to a lifetime of exposure to NMBA at 0.96 ppm, the agency said in a statement.
"Distributing losartan containing NMBA up to 9.82 ppm will help maintain adequate losartan supply while companies obtain approval for manufacturing processes that produce nitrosamine-free losartan for patients," the FDA said.
The FDA said manufacturers should contact FDA's Drug Shortages Staff when manufacturers' testing of losartan shows levels of NMBA that exceed the interim acceptable intake limit of 0.96 ppm. FDA will determine on a case-by-case basis whether lots containing NMBA greater than 0.96 ppm should be released for distribution.
NMBA is one of three nitrosamine impurities detected in angiotensin II receptor blockers valsartan, losartan, and irbesartan, as well as some combination drugs that contain these medications, since the summer of 2018. The FDA maintains an updated list of recalled sartan products on its website.
Earlier this month, the FDA approved a new generic of valsartan (Diovan) made by Alkem Laboratories.
"We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines. So to address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products," FDA Commissioner Scott Gottlieb, MD, said in a news release.
The FDA said it is working with companies and international regulators to ensure products entering the US market do not contain nitrosamine impurities.
I think it was "dharmabum" who first raised the early alarm about some sort of "recall" going on with a med (that I think she was on), Losartan (perhaps it was some other Losartan formula name she mentioned), but I do believe this Losartan drug was the one she referred to and was concerned about (I looked for but cannot find her post on this) - but, she was rightly concerned, as when I also looked for further articles on this subject - the first and subsequent "news" coming out about this drug and where this drug was manufactured/packaged/assembled ... reported a contamination "problem", and perhaps they had been having this problem for a while. There have been ongoing and evolving reports out about Losartan (and this plant, and other Losartan containing type drugs), and, perhaps other drugs (not losartan) that were also from this plant - that they found to be containing some (possibly multiple?) contaminants - main concern seemed to be trace amounts of some kind of possibly carcinogenic rocket fuel contaminant!! Talk about a BP med with a boost to it.
Bad for profits to have this drug (and other formulas) pulled/held/suspect. Patients and docs who otherwise found the drug good for their BP's, were now inconvenienced, worried, not taking/using the drug. Contaminates and shortages are not good for anyone.
Interesting how FDA has "weighed the risks" and are now letting the drug be doled out, with the contaminant problem "soon" (maybe 6 months?) to be fixed? Um, how long may the drug have been contaminated before it was found to be so, and how long have people already been taking this drug in the contaminated version - does taking it in the "minutely" contaminated form for another 6 months make any dif? I heard a nice lady once, called Rosalie Bertell, say there was no such thing as "just a little bit" of poison being OK, like arsenic?, that was her example, Rosalie said our bodies were simply not built for it - that the correct amount our bodies should ingest was zero, zilch, nil, nada.
Being that "Michaele" brought this BP med subject up today - i thought i would post this late article. It was interesting the 2009 study that Michaele found and mentioned today (about losartan and fibrosis reduction) but there were very few people in the study back then. Another study was started in 2018, kind of on the same theory, but it went no where, as it's sample size was also small (way too small). So, the question is still out there - does losartan have an effect on reducing fibrosis as well as affecting your BP, and is there such a thing as a losartan deluxe where you get a side of rocket fuel with that?
FDA Permits Temporary Distribution of Tainted Losartan
Megan Brooks
DISCLOSURESMarch 21, 2019
Amid an ongoing series of tainted sartan drug recalls, the US Food and Drug Administration (FDA) announced Wednesday that it will not object to temporary distribution of losartan that contains the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until it can be eliminated.
The goal is to ensure continued access, the FDA said. The agency expects many companies will be able to make losartan without nitrosamine impurities and replenish the US supply in about 6 months.
Scientists at FDA evaluated the risk of exposure to NMBA at levels up to 9.82 ppm and found that it presents "no meaningful difference" in cancer risk over 6 months compared to a lifetime of exposure to NMBA at 0.96 ppm, the agency said in a statement.
"Distributing losartan containing NMBA up to 9.82 ppm will help maintain adequate losartan supply while companies obtain approval for manufacturing processes that produce nitrosamine-free losartan for patients," the FDA said.
The FDA said manufacturers should contact FDA's Drug Shortages Staff when manufacturers' testing of losartan shows levels of NMBA that exceed the interim acceptable intake limit of 0.96 ppm. FDA will determine on a case-by-case basis whether lots containing NMBA greater than 0.96 ppm should be released for distribution.
NMBA is one of three nitrosamine impurities detected in angiotensin II receptor blockers valsartan, losartan, and irbesartan, as well as some combination drugs that contain these medications, since the summer of 2018. The FDA maintains an updated list of recalled sartan products on its website.
Earlier this month, the FDA approved a new generic of valsartan (Diovan) made by Alkem Laboratories.
"We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines. So to address the public health consequences of these shortages, we've prioritized the review of generic applications for these valsartan products," FDA Commissioner Scott Gottlieb, MD, said in a news release.
The FDA said it is working with companies and international regulators to ensure products entering the US market do not contain nitrosamine impurities.