“Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API)”.
We have been following recall notices about blood pressure drugs valsartan and losartan.
This latest recall follows several others announced since July, when the FDA announced the recall of five separate valsartan blood pressure drugs over possible NDEA and NDMA contamination.
Many more were announced in August as the recall spread to Canada and the European Union. And earlier this month, a blood pressure drug known as irbesartan was recalled as well.
So far, recall notices have been issued for multiple lots, with multiple updates, by multiple generic drug manufacturers. Some of the manufacturers who issued recalls in the past several months include:
Teva, Legacy, Torrent, Sandov, Macleods, Aurobindo Pharma USA, Mylan’s.
This is by far the longest-running, ongoing spread of recalls we’ve noticed in the past three years.
What is going on?
Turns out that we weren’t the only curious ones. Bloomberg.com spent a year investigating the FDA’s regulations of the generic drug industry and found a drop-off in inspections and the softening of penalties when problems are identified. Data integrity is compromised as well. FDA inspections at factories from West Virginia to China give cause to doubt the data meant to prove the safety and efficacy of drugs.
Bloomberg’s has done a lot of research on generic drugs and the FDA’s quality control. One of their conclusion was that due to the data integrity problems, even the drugs that are not being recalled may not be as effective or safe as they are meant to be.
Safety and efficacy concerns are not limited to drugs using active ingredients from India and China, but also to drugs manufactured in the States.
Bloomberg has a host of articles around the subject of generic drugs and where we are headed, and they are not encouraging.
One of the reasons for the increased laxity in regulations may be the generic drug initiative run by Scott Gottlieb, FDA Commissioner.
Scott Gottlieb was the FDA Commissioner since May 2017, and spearheaded several important initiatives. Among these are finding solutions to the opioid crises, food safety modernization, an initiative to minimize youth nicotine, youth vaping, and general nicotine addiction.
Another top priority for Gottlieb was getting more generic drugs into the market. The extra competition would drive down prices. This has drawn praise from both parties in Congress and, as an aside, is one of the issues President Trump said he would take care of if he was voted President. Everybody was happy.
In the effort to fast-track generic drug manufacture, some approvals for generic drugs may have come at the expense of quality assurance and oversight to ensure the efficacy and safety of the drugs.
On March 5, 2019, FDA Commissioner Scott Gottlieb announced that he was resigning from his post as FDA Commissioner. He will be leaving in April. Will the FDA tighten regulations after he leaves? We can’t be sure.
They will definitely keep working on keeping more drugs accessible to more people- and on the other initiatives Gottlieb spearheaded during his reign as the FDA Commissioner.
Perhaps, now that Gottlieb put a system in place, they will spend more time fixing the bugs in the system and plugging the holes that allow ineffective and unsafe drugs to hit the market. Maybe we will all notice that our medication is working better all of a sudden, and spend less time visiting Doctors to try different versions of what is supposed to be the same basic drug. Maybe the drug prices will go up again. Who knows?
In the meantime, keep checking for updates on drug recalls on our website, or go directly to the FDA’s website.
Above all, Be Safe.
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