Whats Behind The Problem
The culprits behind the latest recalls are N-nitrosodiethylamine and N-nitrosodimethylamine , substances that occur naturally in certain foods, drinking water, air pollution, and industrial processes. The chemicals have been classified as probable human carcinogens by the International Agency for Research on Cancer .
These are organic compounds that can be found in food products such as bacon and other cured meats, fish, cheese, and malt beverages, including beer, according to a policy summary report by the Technology Centre Mongstad in Kaland, Norway.
In the worst-case scenario, the FDA estimates that if 8,000 people took the highest dose of valsartan containing NDMA daily for four years, it might cause one additional case of cancer over the lifetimes of those 8,000 people. The agency underscores that, in reality, the risk is probably much less because patients are likely to receive a much smaller dose of the impurity.
Blood Pressure Medication Recalled After Potential Cancer
Lupin Pharmaceuticals Inc. is recalling these specific types of blood pressure medications for possibly containing high levels of a cancer-causing substance.
A recall notice from the U.S. Food and Drug Administration says two types of blood pressure medications are being recalled after tests revealed potentially high levels of a cancer-causing chemical.
The manufacturer, Lupin Pharmaceuticals Inc., is voluntarily recalling its Irbesartan and Hydrochlorothiazide blood pressure tablets at the consumer level, according to reports by SILive.com and Health.com.
As part of Lupins ongoing assessment, analysis revealed that certain tested API batches were above the specification limit for the impurity, N-nitrosoirbesartan, the FDA says in its recall notice.
Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the U.S., the FDA says.
Lupin discontinued the marketing of Irbesartan and Irbesartan and HCTZ tablets in January 2021, the FDA noted.
The FDA says Irbesartan and hydrochlorothiazide tablets are packaged in 30- and 90-count bottles and were distributed nationwide in the U.S. to wholesalers, drug chains, mail order pharmacies and supermarkets.
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Blood Pressure Drug Linked To Pancreatic Cancer In Women
There is no shortage of drugs to treat high blood pressure.
No fewer than 14 different classes of medications have been approved for hypertension. And within those classes are more than 110 drugs.i
So why would any doctor advise you to take one that not only works poorly, but also raises your risk for the deadliest type of cancer?
Pancreatic cancer is the fourth leading cause of cancer death in the United States. It has a five-year survival rate of only 7%. That makes it the deadliest type of cancer.ii
A major study shows that one common class of blood pressure medication dramatically increases the risk of pancreatic cancer in women.iii
The study followed 145,000 women between the ages of 50 and 79 for five years.iv
Calcium Channel Blockers Raises Womens Cancer Risk
Subjects taking short-acting CCBs for any length of time had a 66% greater risk of pancreatic cancer. If they used the drugs more than three years, their risk was 107% higher.v
The medications include:
Dr. Zhensheng Wang led the study. Hes a researcher at Baylor College of Medicine in Houston.
Short-acting CCBs are the least effective kind of blood pressure drugs available, Dr. Wang said. And that might be the root cause of their increased pancreatic cancer risk, he said.vi
Since people who take short-acting CCBs get poor blood pressure control from the medications, it puts them at higher risk of diabetesAnd diabetes is a known risk factor for pancreatic cancer.
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Can I Get Cancer From Taking Arbs
The FDA states that the risk of anyone actually getting from taking a contaminated blood pressure pill is very, very small. In a statement, the FDA estimated that, in a worst-case scenario, if 8,000 people took the highest dose of a contaminated valsartan medication every day for four years, it might cause one cancer case among those 8,000 people.
This represents an extremely low risk to anyone who takes an ARB to reduce their blood pressure.
Popular Blood Pressure Drugs Linked To Cancer
pular drugs linked to elevated cancer risk, but some doctors aren’t convinced.
In a meta-analysis of nine published studies the blood pressure drugs called angiotensin-receptor blockers were associated with a modest but statistically significant 8 percent increase in the relative risk of a new cancer, according to Dr. Ilke Sipahi, and colleagues at Case Western Reserve University School of Medicine in Cleveland, Ohio.
Angiotensin-receptor blockers, or ARBs, are a drug class that includes Diovan, Cozaar, Micardis, and Atacand.
A full list of the study drugs can be found at the bottom of the story.
On the other hand, there was no increase in the risk of dying from cancer, perhaps because follow-up in the trials was too short, the researchers said online in the medical journal The Lancet.
The findings are “disturbing and provocative” and raise important safety issues both for doctors and regulators, argued Dr. Steven Nissen, of the Cleveland Clinic, in an accompanying Comment article in the journal.
Nissen said regulators should immediately review the possible association and “promptly report” what they find. In the meantime, he added, doctors should use the drugs with caution, perhaps prescribing angiotensin-converting enzyme inhibitors instead.
Other experts, though, challenged the findings, saying the study was flawed. And many said they feared that publicity would lead to patients stopping what are very often life-saving medications.
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More Than 30 Batches Of Pills Used To Treat High Blood Pressure Have Been Contaminated By An Impurity That Can Increase The Risk Of Cancer
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The Medicines and Healthcare products Regulatory Agency stressed that they are recalling batches of the drugs from pharmacies and suppliers rather than patients and that there is no evidence they have caused harm, although investigations are ongoing.
The recall affects 31 batches of drugs containing Irbesartan and 2 containing Losartan, medicines which are used to treat high blood pressure, heart failure, type 2 diabetes and kidney disease in adults who also have high blood pressure.
Patients who take the affected drugs should speak to a doctor or pharmacist, the MHRA say, and should not stop taking their medicine without doing so. Government advice states that the health risk of suddenly stopping medication is higher than the potential risk posed by the impurity.
Dr June Raine, chief executive of the MHRA, called on healthcare staff to check their batches of sartan-containing drugs while the agency further investigates the issue.
Patient safety is our watchword. Were recalling batches of certain sartan-containing products as a precautionary measure while we continue our investigation. Its important that healthcare professionals check their stock to quarantine and return these batches, she said.
What To Do If You’re Taking A Recalled Valsartan Medication
You may also want to speak with your local pharmacist or call the drug’s manufacturer. They can help you determine the best method of disposal for the recalled medication. In some cases, you may be eligible for a refund as well. Contact your prescription manufacturer for a refund or return information.
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Blood Pressure Meds Recalled For Possibly Containing A Cancer
Two types of blood pressure medication made by the company Lupin Pharmaceuticals are being recalled because they may contain high levels of a substance that could cause cancer.
The Food and Drug Administration said late last week that Lupin is voluntarily recalling certain dosages of irbesartan tablets and irbesartan and hydrochlorothiazide tablets. Both are used to treat hypertension, or high blood pressure, and were distributed in 30- and 90-count bottles nationwide.
The company found that certain batches of those drugs were above the specification limit for the impurity N-nitrosoirbesartan, which could cause cancer in humans. It says its received no reports of illness that appear to be related to this issue, but is acting out of an abundance of caution. Its recalling:
- All batches of irbesartan tablets USP 75mg, 150mg and 300mg
- All batches of irbesartan and hydrochlorothiazide tablets USP, 150mg/12.5mg and 300mg/12.5mg
Lupin says it received four reports of illness from irbesartan and none from irbesartan and hydrochlorothiazide between October 2018 and the end of September 2021.It discontinued the marketing of both drugs in January of this year.
Are Blood Pressure Medications Linked To Cancer
In late 2018, a few drug manufacturers reported that some batches of their blood pressure medications tested positive for contamination by a cancer-linked chemical called N-Nitrosodimethylamine and other related impurities. Consuming high doses of NDMA could potentially cause a person to develop cancer, but the amount of the chemical in the recalled blood pressure medications does not present an urgent threat to your health.
Out of an abundance of caution, the FDA initiated a recall of these specific medication batches. The recalls include a particular class of blood pressure medications called angiotensin II receptor blockers . These medicines work by reducing blood vessel constriction caused by the hormone angiotensin. Sometimes, ARBs are combined with other medications, such as diuretics, in a combination blood pressure pill.
The blood pressure medication recall includes these drugs, produced by a small group of manufacturers:
Combination pills that also contain drugs like HCTZ
Not every brand of ARBs has been recalled. Many drug manufacturers produce these common medications and have not reported problems with impurities. You can find out if your particular brand of ARB has been recalled by searching the list of recalled ARBs on the FDAs website. You can also take the medicine bottle to your pharmacy and ask the pharmacist for help.
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Blood Pressure Medications Not Linked To Cancer Risk Scientists Say
SOPHIA ANTIPOLIS, France Patients with high blood pressure have plenty to worry about without thinking their medications will make them sick. For decades however, there have been conflicting reports that antihypertensive drugs may increase a persons risk for cancer. Now, a new study is debunking these claims. British researchers say there is no evidence drugs which lower blood pressure put you at higher risk of developing cancer.
Our results should reassure the public about the safety of antihypertensive drugs with respect to cancer, which is of paramount importance given their proven benefit for protecting against heart attacks and strokes, says study author Emma Copland in a media release.
The report by the European Society of Cardiology says this debate has been going on for over 40 years. Despite that, no clear link increasing or decreasing cancer risks have been tied to blood pressure medications.
The new study examines approximately 260,000 patients from 31 medical trials. It is the largest report on cancer diagnoses involving participants in random blood pressure drug trials to date.
Blood Pressure Medication Recalled Over Risk Of Cancer
by: Jocelina Joiner, Nexstar Media Wire
by: Jocelina Joiner, Nexstar Media Wire
Lupin Pharmaceuticals Inc. is voluntarily recalling a blood pressure medication that possibly contains high levels of a cancer-causing impurity, according to the U.S. Food and Drug Administration.
The company is recalling its Irbesartan and Hydrochlorothiazide tablets at the consumer level after an analysis revealed that certain API batches contained the impurity N-nitrosoirbesartan a probable human carcinogen at levels above the specification limit.
Lupin is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the United States.
The batches of the tablets are packaged in 30- and 90-count bottles and were distributed nationwide in the United States to wholesalers, drug chains, mail-order pharmacies and supermarkets.
Lupin stopped marketing Irbesartan and Irbesartan and HCTZ tabs in January 2021.
Lupin has received no reports of illness that appear to relate to this issue and is recalling the products out of an abundance of caution.
The pharmaceutical company is notifying its wholesalers, distributors, drug chains, mail-order pharmacies and supermarkets by phone and through the recall notification and is arranging for the return of all the affected products, according to the recall notice.
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What Is The Risk Of Getting Cancer From One Of These Drugs
The FDA says it is very small. The amount of NDMA found in the recalled valsartan drugs exceeds acceptable levels. Records from drug manufacturers show the impurity may have been in the valsartan products for up to 4 years. The FDA estimates that if 8,000 people took the highest valsartan dose, which is 320 milligrams, from recalled batches every day for 4 years, there would likely only be one additional case of cancer over the life of those 8,000 people.
For context, 1 in 3 people in the United States will be diagnosed with cancer in their lifetime.
Various Blood Pressure Medications Show Similar Results
The report investigates five different types of antihypertensive drugs: angiotensin-converting enzyme inhibitors , angiotensin II receptor blockers , beta blockers, calcium channel blockers , and diuretics.
Study authors estimate how these medications impact the chances for all types of cancers and the risk of dying from the disease. They also take into account differences in age, gender, body size, smoking habits, and each patients antihypertensive prescription history.
During an average trial period of four years, 15,000 new cancer diagnoses were reported. Regardless of age, size, or health history, researchers say none of the five drugs dramatically increase the risks for cancer.
Looking at the hazard ratio for developing cancer, the study reveals all of the high blood pressure medications remain within a few points of the average cancer risk. The report also finds no evidence taking blood pressure drugs will lead to breast, colorectal, lung, prostate, or skin cancers.
Our study has addressed an ongoing controversy about whether antihypertensive medication increases the risk of developing cancer, the epidemiologist from the University of Oxford adds. We used the largest individual-level randomized evidence on antihypertensive medication to date and provide evidence for the safety of blood pressure lowering drugs in relation to cancer.
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Check Your Medicine Cabinet: Blood Pressure Medications Recalled Over Potential Cancer
Lupin Pharmaceuticals is voluntarily recalling several batches of two blood-pressure drugs with high levels of a known carcinogen, per the FDA.
Certain Irbesartan tablets and Irbesartan and Hydrochlorothiazide tablets contain more of the impurity N-nitrosoirbesartan than is safe.
Patients are advised to keep taking their medications but should contact their doctors to seek an alternative treatment.
Two potentially lifesaving blood-pressure drugs could be causing more harm than good, according to a recall notice posted by the U.S. Food and Drug Administration . Lupin Pharmaceuticals announced a voluntary recall of all of its Irbesartan tablets and Irbesartan and Hydrochlorothiazide tablets, many of which could contain high levels of a cancer-causing impurity.
The recall was issued last week after testing revealed that several batches of both medications, which are used to lower blood pressure, exceeded acceptable levels of the impurity N-nitrosoirbesartan, a probable human carcinogenmeaning it could cause cancer, based on laboratory testing, the FDA explains. More than 90% of the over 300 known N-nitroso compounds were found to be carcinogenic when tested on animals, per the FDA.
Out of an abundance of caution, the FDA notice reads, Lupin is recalling all batches of Irbesartan tablets and all batches of the drug Irbesartan and Hydrochlorothiazide tablets in the United States. The full list of recalled lot numbers is available at the FDAs site.
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Blood Pressure Medications Recalled For Possible High Carcinogen Levels
The company is voluntarily recalling all batches of irbesartan tablets in 75-milligram , 150-mg and 300-mg strengths, as well as irbesartan/hydrochlorothiazide tablets in 150-mg/12.5-mg and 300-mg/12.5-mg strengths.
Lupin said it stopped marketing the tablets in January. Both types are used to treat hypertension, or high blood pressure.
An analysis during the companyâs testing process showed that some tested batches — but not finished product batches — were above the limit for N-nitrosoirbesartan, an impurity that may cause cancer.
âAlthough Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches,â according to the notice.
The company received four reports of illness from irbesartan tablets and no reports of illness from irbesartan/hydrochlorothiazide tablets between Oct. 8, 2018, and Sept. 30, 2021, which includes the earliest date of shipment from the manufacturing site for any of the affected batches. The four illnesses werenât related to the impurity, the company said.
People who are taking these tablets should continue taking their medication and contact their pharmacist or doctor to arrange a different treatment, according to the notice.
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