- FDA reviewers support efficacy of Forest Labs' IV antimicrobial ceftaroline for treating pneumonia, complicated skin and skin structure infections
- FDA updates label for Pfizer's Tygacil to warn of increased mortality risk
- FDA approves Abbott's HBV molecular diagnostic for measuring viral load
- FDA approves new version of Allergan's Lumigan
- FDA approves Reckitt Benckiser's Suboxone sublingual film for treatment of opioid dependence
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
Recent study findings prompt FDA to conduct safety review of ARBs, potential cancer risk
What's This?
The Food and Drug Administration is conducting a safety review of angiotensin II receptor blockers (ARBs), which are commonly used hypertension drugs, in light of recent data suggesting that they could be associated with a modestly increased risk of cancer. The data were from a meta-analysis of trials published before November 2009 that had evaluated any of the 7 currently available ARBs. The analysis included findings for telmisartan, valsartan, candesartan cilexetil, irbesartan,...
The Food and Drug Administration is conducting a safety review of angiotensin II receptor blockers (ARBs), which are commonly used hypertension drugs, in light of recent data suggesting that they could be associated with a modestly increased risk of cancer.
The data were from a meta-analysis of trials published before November 2009 that had evaluated any of the 7 currently available ARBs. The analysis included findings for telmisartan, valsartan, candesartan cilexetil, irbesartan, eprosartan mesylate, olmesartan medoxomil, and losartan potassium.
The researchers discovered that the patients who were randomized to receive ARBs had a significantly increased risk of new cancer occurrence as compared with those who were randomized to receive control therapies. Cancer was diagnosed in 7.2% of the patients treated with ARBs and in 6% of the patients treated with control therapies. However, no statistically significant difference in cancer deaths was observed between the patients who received ARBs and those who received a control treatment (1.8% vs 1.6%, respectively). (Sipahi I, et al. Lancet Oncol 2010;11:627-636.)
The FDA said it continues to believe that the benefits of ARBs outweigh their potential risks and noted that patients should not discontinue treatment unless directed to do so by their health care provider.
The trials forming the basis of the meta-analysis were not designed to study the effects of ARBs on cancer risk, the regulatory agency pointed out, and therefore it plans to perform a more detailed examination of the data to determine if, in fact, the reported cancers were new.
ARBs linked to modest increase in cancer risk, researchers report 
What's This?
Angiotensin II receptor blockers (ARBs) are associated with a modestly increased risk of cancer, according to data from a recent meta-analysis.Dr. Ilke Sipahi of Case Western Reserve University in Cleveland, Ohio, and colleagues analyzed data from trials published before November 2009 that evaluated any of the 7 currently available ARBs. Their analysis included randomized controlled trials in which an ARB was given in >=1...
Study supports use of adenoma detection rate as quality indicator for colonoscopy screening
What's This?
New data suggest that the endoscopist's adenoma detection rate is an independent predictor of a patient's colorectal cancer (CRC) risk following a screening colonoscopy, supporting the use of this variable in quality-assessment and quality-improvement programs for CRC screening.The study evaluated the association between 2 quality indicators for colonoscopy--adenoma detection rate and cecal intubation rate--and the risk of interval CRC, defined as cases of colorectal...
Single flexible sigmoidoscopy screening reduces rates of CRC, CRC-related mortality in older adults, trial data show
What's This?
Among adults aged 55 to 64 years, a single flexible sigmoidoscopy screening might reduce the incidence of colorectal cancer (CRC) by more than 30% and death resulting from CRC by more than 40%, according to findings from a randomized, multicenter trial conducted in the United Kingdom. The trial included 170,432 men and women aged 55 to 64 years, all of whom indicated on a previous questionnaire that they would accept an invitation for flexible sigmoidoscopy screening. The...
Addition of bevacizumab, thalidomide to docetaxel, prednisone shows promise in midstage prostate cancer trial
What's This?
In men with metastatic castration-resistant prostate cancer, the combination of bevacizumab and thalidomide plus docetaxel and prednisone doubled overall survival time relative to the survival time predicted for this patient population, according to data from a recently published study.Angiogenesis is linked to progression in prostate cancer and is inversely associated with survival, the authors explained. Two antiangiogenic drugs, thalidomide and bevacizumab, have different...
30th Annual SABCS
December 12-16, 2007 San Antonio, Texas- Completion axillary dissection may not be required after positive sentinel node biopsy
- Denosumab increases BMD in women with breast cancer receiving AI therapy, findings indicate
- Continuation of tamoxifen beyond standard 5 years reduces breast cancer recurrence, preliminary data show
- Anastrozole appears superior to tamoxifen in reducing risk of recurrence in patients with early breast cancer, data show
- Docetaxel plus cyclophosphamide improves overall survival better than standard chemotherapy in women with breast cancer, data show
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
- PSA screening controversy increases with release of mortality studies with conflicting results, modest benefits
- Men with biopsy Gleason score 7, tertiary grade 5 disease face similar risk of PSA recurrence as men with higher Gleason score disease, study data suggest
- Researchers evaluate predictors of re-excision, residual disease in women with close, positive margins following partial mastectomy
- Addition of both androgen suppression therapy, external-beam radiation to brachytherapy decreases prostate cancer-specific mortality in men with high-risk disease, study shows
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
- Radiation therapy for prostate cancer raises bladder, rectal cancer risk, study indicates
- ACE inhibitors, ARBs may reduce risk of nonmelanoma skin cancer in high-risk patients, researchers report
- Dietary intervention appears useful in men with prostate cancer
- Many survivors of childhood cancer do not get cancer-focused aftercare, study shows
