Breaking News
October 18, 2018 - Using NMR to Reduce Fraud
October 18, 2018 - New automated model identifies dense breast tissue in mammograms
October 18, 2018 - Mysterious polio-like illness baffles medical experts while frightening parents
October 18, 2018 - Cases of Acute Flaccid Myelitis on the rise across U.S.
October 18, 2018 - Dietary fiber reduces brain inflammation during aging
October 18, 2018 - New tool could help prioritize recovery efforts for the poorest hit by natural disasters
October 18, 2018 - Hundreds of dietary supplements shown to contain unapproved drugs
October 18, 2018 - Active Pharmaceuticals ID’d in >700 Dietary Supplements
October 18, 2018 - Cell death protein also damps inflammation
October 18, 2018 - Health Highlights: Oct. 15, 2018
October 18, 2018 - Largest study of ‘post-treatment controllers’ reveals clues about HIV remission
October 18, 2018 - Bad Blood in Silicon Valley: A conversation with John Carreyrou
October 18, 2018 - ANTRUK’s Annual Lecture sends out message on shortage of funds for antibiotic research
October 18, 2018 - NAM special publication outlines steps to ensure interoperability of health care systems
October 18, 2018 - Novel method uses just a drop of blood to monitor effect of lung cancer therapy
October 18, 2018 - New blood test could spare cancer patients from unnecessary chemotherapy
October 18, 2018 - Training young researchers to work with data volumes arising in the health sector
October 18, 2018 - New Metrohm IC method is reliable and convenient to use for zinc oxide assay
October 18, 2018 - Global AIDS, TB fight needs more money: health fund
October 18, 2018 - Understanding the forces that cause sports concussions
October 18, 2018 - Research points to new target for treating periodontitis
October 18, 2018 - New tool improves assessment of postpartum depression symptoms
October 18, 2018 - From Biopsy to Diagnosis
October 18, 2018 - Sexual harassment and assault linked to worse physical/mental health among midlife women
October 18, 2018 - Stumped by medical school? A Q&A with a learning specialist
October 18, 2018 - Self-lubricating condoms may help raise condom usage
October 18, 2018 - Targeting immune checkpoints in microglia could reduce out-of-control neuroinflammation
October 18, 2018 - Study finds changes in antiepileptic drug metabolism during different trimesters of pregnancy
October 18, 2018 - Autonomic nervous system directly controls stem cell proliferation, study shows
October 18, 2018 - FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
October 18, 2018 - Sleeping Beauty technique helps identify genes responsible for NAFLD-associated liver cancer
October 18, 2018 - Many U.S. adults confused about primary care, study shows
October 18, 2018 - UC researcher focuses on light-mediated therapies to target breast cancer
October 18, 2018 - With philanthropic gifts, Stanford poised to make major advances in neurosciences | News Center
October 18, 2018 - Mice study shows antibiotics are not always necessary to cure sepsis
October 18, 2018 - Researchers discover why heart contractions are weaker in individuals with HCM
October 18, 2018 - Participation in organized sport during childhood may have long-term skeletal benefits
October 18, 2018 - Probiotic/antibiotic combination could eradicate drug-resistant bacteria
October 17, 2018 - More Socioeconomic Challenges for Hispanic Women With HIV
October 17, 2018 - 49,XXXXY syndrome – Genetics Home Reference
October 17, 2018 - Scientists uncover possible new causes of Tourette syndrome
October 17, 2018 - Girl undergoes unusual heart surgery after compassionate-use exemption | News Center
October 17, 2018 - Health Issues That Are Sometimes Mistaken for Gluten Sensitivity
October 17, 2018 - Elective induction of labor at 39 weeks may be beneficial option for women and their babies
October 17, 2018 - New smart watch algorithms can accurately monitor wearers’ sleep patterns
October 17, 2018 - Researchers demonstrate epigenetic memory transmission via sperm
October 17, 2018 - FDA, DHS announce memorandum of agreement to address cybersecurity in medical devices
October 17, 2018 - Health Tip: Know the Risks of Chicken Pox
October 17, 2018 - Immunotherapy effective against hereditary melanoma
October 17, 2018 - Researchers reveal new mechanism for how animal cells stay intact | News Center
October 17, 2018 - Alzheimer's Goes Under the Cryo-Electron Microscope
October 17, 2018 - Medicare for all? CMS chief warns program has enough problems already
October 17, 2018 - Metrohm Raman introduces Mira P handheld Raman system
October 17, 2018 - Expanding the knowledge about hippocampus to better understand cognitive deficits in MS
October 17, 2018 - Study of Nigerian breast cancer patients reveals prevalence of aggressive molecular features
October 17, 2018 - Many healthy children may have metabolic risk factors, finds study
October 17, 2018 - A new antibiotic could be a better, faster treatment for tuberculosis
October 17, 2018 - “I will not become a Robot Doctor”: A medical student vows to practice compassion
October 17, 2018 - Study findings may explain sporadic outbreaks of C. difficile infections in hospitals
October 17, 2018 - Purdue researchers develop new chemical process to find better drug ‘fits’ for patients
October 17, 2018 - Yale researchers develop way to attack RNA with small-molecule drugs
October 17, 2018 - New pragmatic study launched to understand the effectiveness of new type 2 diabetes drug
October 17, 2018 - Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
October 17, 2018 - Nine cases of polio-like illness suspected in children in illinois
October 17, 2018 - Eisai enters into agreement with Eurofarma for development and sales of lorcaserin in 17 countries
October 17, 2018 - Patients once thought incurable can benefit from high-dose radiation therapy
October 17, 2018 - Researchers awarded grant to advance testing of experimental heroin vaccine
October 17, 2018 - Researchers examine SSRI use during pregnancy and major gestational malformations
October 17, 2018 - FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T
October 17, 2018 - Reliable Respiratory announces acquisition of Attleboro Area Medical Equipment
October 17, 2018 - Study reveals link between childhood abuse and higher arthritis risk in adulthood
October 17, 2018 - Research shows people over 65 are not performing enough physical activity
October 17, 2018 - FDA Approves Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
October 17, 2018 - Weight gain after smoking cessation linked to increased short-term diabetes risk
October 17, 2018 - Researchers find opportunity to control salt-sensitive hypertension without exercising
October 17, 2018 - Women not warned about cancer associated with breast implants
October 17, 2018 - Metrohm offers robust handheld Raman analyzer for Defense and Security
October 17, 2018 - Modeling Non-Numerical Data in Systems Biology
October 17, 2018 - Research aims to address health disparities in African-American men
October 17, 2018 - Human and cattle decoys trap outdoor-biting mosquitoes in malaria endemic regions
Recalled blood pressure drugs not linked to increased short term cancer risk

Recalled blood pressure drugs not linked to increased short term cancer risk

image_pdfDownload PDFimage_print
Credit: CC0 Public Domain

Products containing the withdrawn blood pressure drug valsartan are not associated with a markedly increased short term risk of cancer, finds an expedited analysis published by The BMJ today.

The findings provide reassuring interim evidence about the risk of cancer in patients treated with valsartan products, but the authors say further studies are required to evaluate the risks for single cancers as well as longer term effects.

In July 2018, some valsartan products manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals were suspected of having been contaminated with N-nitrosodimethylamine (NDMA), an impurity that can cause cancer.

Following the discovery, both European medical agencies and the US Food and Drug Administration (FDA) withdrew affected valsartan products from the market.

To better understand the possible consequences and help inform regulatory bodies about this potential public health issue, the Danish Medicines Agency collaborated with the University of Southern Denmark to assess the association between use of potentially NDMA contaminated valsartan products and risk of cancer.

Using data from Danish health registries, they included 5,150 patients aged 40 years and over with no previous cancer who used products containing valsartan between 1 January 2012 and 30 June 2018.

Based on product analysis and dose used, patients were classified as being exposed or not exposed to NDMA and were followed from one year after entering the study, for a median of 4.6 years, during which time cases of cancer were recorded.

After taking account of age, sex, and other potentially influential factors, the researchers found that, overall, exposure to potentially NDMA contaminated valsartan products showed no association with cancer compared with exposure to valsartan products that were not contaminated with NDMA. There was also no evidence of a dose-response pattern.

However, when they analysed single cancers, they found a slightly increased (but not statistically significant) risk of colorectal cancer and uterine cancer in patients exposed to NDMA. While they cannot fully explain this, it might require further study.

More importantly, the limited follow-up means that assessment of long-term effects is not possible, and the low number of events makes interpretation of estimates for single cancer outcomes difficult.

Nevertheless, the researchers believe that their results can support regulators in their evaluation of the potential public health impact of NDMA exposure via valsartan drugs—and provide some reassurance for people who might have been exposed.

They conclude: “Our results do not imply a marked increased short term overall cancer risk in users of valsartan contaminated with NDMA. However, uncertainty persists regarding single cancer outcomes, and studies with longer follow-up are needed to assess long-term cancer risk.”

In a linked editorial, Rita Banzi and Vittorio Bertele’ at the Center for Drug Regulatory Policies in Milan, Italy, say “this study alone cannot dispel doubts about the potential risk for patients in the longer term, but it helps inform decision-making around this episode.”

“It also illustrates the usefulness of national registries for examining the relations between risk factors and health problems and how research can give a prompt response whenever public health concerns emerge,” they add.

Regulatory actions coupled with the generation of robust evidence, they say “are the keys to responding promptly to emerging public health concerns.”


Explore further:
Chinese firm recalls heart drug as US, EU raise concerns

More information:
Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study, www.bmj.com/content/362/bmj.k3851

Editorial: Regulatory response to contaminated valsartan, www.bmj.com/content/362/bmj.k3855

Provided by:
British Medical Journal

Tagged with:

About author

Related Articles