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FDA recalls another Blood Pressure Medication for Cancer Concerns Timely Insights on Laws, Issues and New Developements

The U.S. FDA just announced another blood pressure medication recall due to unacceptably high levels of an impurity. Lupin Pharmaceuticals Inc. has issued a voluntary recall of all batches of the company’s irbesartan tablets, as well as its irbesartan plus hydrochlorothiazide (HCTZ) tablets. The impurity is N-nitrosoirbesartan, which has been listed as a “probable carcinogen,” meaning it may cause cancer.

Lupin joins several companies in recent history recalling blood pressure meds over cancer concerns. Back in 2019, blood-pressure-medication-recalls-for-possible-cancer-causing-impurity announcements seemed to come like clockwork. In 2019 alone, three different blood pressure medication recalls occurred – in January, March, and September.

The year 2018 also featured multiple blood pressure medication recalls from different manufacturers.

This recall trend in the past has included various angiotensin II receptor blockers (ARB). Irbesartan made by Sciegen Pharmaceuticals, Inc. was already involved in a 2018 recall. Irbesartan is an ARB. Angiotensin II is a substance that causes blood vessels to narrow; so blocking receptors for this substance can, in turn, lead to the widening of blood vessels, which can lower blood pressure.

The irbesartan plus HCTZ tablet combines another blood pressure medication that works through a different mechanism with irbesartan. HCTZ is a diuretic, which means it makes one urinate more often. Urinating more can help one remove excess salt and fluid from the body, which, in turn, can also help reduce blood pressure.

Not all Irbesartan-containing products are affected

Lupin is not the only company to make and distribute irbesartan-containing products, and not every type of irbesartan is affected by the recall. Users are encouraged to examine the label on the bottle to identify the med’s maker, and to address any questions to a pharmacist.

Lupin had previously discontinued, in January 2021, the marketing of both irbesartan alone and irbesartan plus HCTZ. Nevertheless, such tablets are still available. As a result, Lupin is recalling all tablets that may have been shipped from October 8, 2018, to September 30, 2021.

Impurities 101

When something is called an “impurity,” it doesn’t usually mean massive amounts of the impurity are present. The (probably) low levels of impurities are unlikely to cause cancer after the ingestion of a single irbesartan tablet. Such an impurity may become a problem only after one repeatedly ingests it over a period of time. And as with all recalls, this one doesn’t necessarily mean users should stop irbesartan or irbesartan plus HCTZ immediately. As with other drug recalls, users are advised to talk to their doctors before any change in medication(s).

Recalls Beg the Question

All of these blood pressure medication recalls beg the question: Why have we seen so many of these drugs recalled? One has to wonder whether medication safety regulations have become too loose, or whether the system itself is broken beyond repair.

The recall of all these blood pressure medications is, to say the least, concerning. Unlike many drugs advertised on television for real or imagined “illnesses” (ADHD? general anxiety?), blood pressure medications are often necessary for many people.

Big Pharma Influence on the FDA

The biggest problem in the FDA is undeniably its too-cozy relationship with the companies it is charged with regulating.

The drug industry’s troubling power over FDA is exercised in several ways. In 1992, under drug industry pressure for not approving drugs fast enough – at a time when FDA rubber-stamped drugs faster than any agency of its kind in the world – the agency fell under the auspices of the Prescription Drug User Fee Act (PDUFA)]. Ratified by congress, this “Act” meant that drug companies paid the agency cash up front for reviewing new drugs. The FDA used some of the “windfall” to hire more staff, who knew exactly why they were hired and exactly what entities paid the freight for their employment. This questionable arrangement led to many scientists in the FDA seeing industry players as their clients, rather than in seeing their clients as the public, the taxpayers who were also paying some of the FDA salaries.

A second way industry influences FDA is that the agency has too many leaders in the drug division who go along to get along because they don’t like controversy. Like news reporters who understand that advertisers can (and do) dictate the news they write, FDA officials don’t like to take on the powerful forces of the drug industry and its long list of indentured servants (such as Anthony Fauci) in monopolized medicine. The FDA leaders’ position is therefore focused on avoiding conflict (it’s simply a human trait to avoid conflict whenever one can), which means FDA often does the industry’s bidding.

A third way the pharmaceutical industry influences FDA has been the industry’s ability, through political “donations,” to undercut congressional oversight. (There are two pharmaceutical lobbyists in Washington D.C. for every senator and congressional rep.) A series of FDA mistakes in the late 1990s (following PDUFA) led to frequent congressional hearings to make the agency explain its actions, or, in many cases, its lack of proper action. FDA officials were then tasked with explaining to the government’s legislative branch about what went wrong. Now, sadly – for those interested in disinterested scientific inquiry and safe and effective drugs – those days of accountability are gone.

No one in Congress seems much interested in questioning the FDA now, no matter how many high blood pressure meds or any other drugs get recalled. Washington D.C. has seen just one or two days of FDA oversight hearings in the last 13 years, where previously there were dozens of oversight hearings. Therefore, the FDA now operates with virtually no congressional oversight.


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by Matthews & Associates

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