FDA announced a Class 1 recall of Stryker's ShapeMatch Cutting Guides after software defects produced wider cutting ranges and displayed parameters that did not match the guides made, risking joint instability, fracture and revision surgery. FDA received 44 reports.
Section archive
Page 14 of 63
Drug
Prescription drugs, vaccines and their risks and benefits.
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Drug
HIV/AIDS Update - Changes to label for Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
FDA approved label changes for Atripla. Stribild joins the drugs that should not be co-administered, interaction data for raltegravir, boceprevir and telaprevir is added, and the rash warning now advises considering alternative therapy for patients who had life-threatening skin reactions.
Drug
Boulder Diagnostics Announces the European Market Launch for its ParaFlor™ Parasite Detection Kits (PR)
Boulder Diagnostics is launching its ParaFlor kits in Europe for detecting Giardia, Cryptosporidium and Blastocystis in human and veterinary samples. The company says the assays work on fresh and fixed stool in under ten minutes, and that ParaFlor B is the first specific Blastocystis assay.
Drug
Hormone replacement therapy raises risk of breast cancer
Following 41,449 postmenopausal women in the Women's Health Initiative Observational Study, researchers found estrogen-plus-progestin users were 55 percent more likely to develop breast cancer over 11.3 years and 32 percent more likely to die from it than non-users.
Drug
Statins prevent cardiovascular disease, but safer alternatives available
A Cochrane review of 18 randomized trials tied statin use to 14 percent lower all-cause mortality, 25 percent fewer cardiovascular events and 38 percent fewer revascularisations, with no excess adverse effects. The writer notes statins are not cost-effective for everyone.
Drug
Ethical Issues Related to Testing Anthrax Vaccine on Children
Mercola backs the Alliance for Human Research Protection's opposition to a proposed U.S. trial of anthrax vaccine in children, arguing exposure risk has been blown out of proportion. Even vaccine developer Paul Offit advised against the trial, and AHRP wrote to the presidential bioethics commission.
Drug
Hormone therapy like HRT boosts heart disease risk
In Annals of Internal Medicine, Eliseo Guallar and colleagues warn that hormone therapy raises heart disease risk. They address confusion left by the Danish DOPS trial, which reported fewer deaths and heart attacks in early postmenopausal users, against USPSTF advice against preventive use.
Drug
Zithromax and Januvia: Two Commonly-Prescribed Drugs Now Shown to Be Killing Patients
Dr. Mercola notes the FDA is investigating whether a class of diabetes drugs is linked to pancreatic inflammation and pre-cancerous changes, and is adding a heart-risk warning to the Z-Pak. He says he flagged both drugs years before the agency acted.
Drug
Keep Away if Possible: 1 in 4 Chance You'll Be Harmed at a Hospital
Dr. Mercola introduces an interview with Johns Hopkins surgeon Martin Makary on preventable medical error. The New England Journal of Medicine puts hospital harm at one patient in four, and a 2011 Health Grades report estimates over 40,000 harmful or lethal errors daily in the US.
Drug
Type 2 diabetes drugs may boost pancreatic cancer risk
An FDA early communication says unpublished academic findings suggest a possible rise in pancreatitis and pre-cancerous pancreatic duct metaplasia among type 2 diabetes patients taking incretin mimetics. FDA has drawn no new conclusions and is seeking the tissue samples.
Drug
Radiotherapy increases leukemia risk in breast cancer patients
A SEER-based study found women with stage 0 breast cancer who had radiotherapy were more than twice as likely as untreated patients to develop myelodysplastic syndrome or acute myeloid leukemia. Against the general population the excess was 134 percent, or 46 percent after adjusting for age.
Drug
Food Drug Administration warns: Zithromax may lead to potentially fatal heart rhythms
The FDA warned that azithromycin, sold as Zithromax and Zmax, can alter the heart's electrical activity and trigger a potentially fatal irregular rhythm. Labels now cover QT prolongation and torsades de pointes; people with existing QT prolongation or low potassium are most at risk.
Drug
Viagra helps heart failure patients with erectile dysfunction
A review suggests PDE5 inhibitors such as sildenafil, vardenafil and tadalafil suit NYHA class I-II heart failure patients with erectile dysfunction, with few side effects. It warns sexual activity can trigger cardiac events in class III-IV patients and some heart drugs worsen ED.
Drug
Adderall, alcohol induce acute myocardial infarction
A case report in Pediatric Emergency Care describes an adolescent who took a full prescribed daily dose of Adderall while drinking alcohol and had a heart attack. Noting at least three earlier pediatric cases, the authors urge evaluating young stimulant users with chest pain and abnormal ECGs.
Drug
Colonoscopy not harmless
A study in Digestive and Liver Disease found adverse events in 2.4% of colonoscopies done after a positive faecal occult blood test in Alsace, France, about 1% of them serious. Among 10,277 procedures, 48 events were moderate or severe, including 10 perforations and 31 bleeds.
Drug
Boycott This Cancer Screening That Delivers Double Dangerous Radiation
Mercola argues 3D tomosynthesis adds radiation rather than removing it, since the machine takes multiple x-rays in an arc and women are still told to get a 2D mammogram too. He cites a 2010 estimate of 20-25 fatal radiation-induced cancers per 100,000 women screened.
Drug
Diabetes mellitus drug Actos linked to bladder cancer
A meta-analysis of 17 studies found pioglitazone, sold as Actos, came with 20 percent higher bladder cancer risk, rising to 42 percent past two years of use. Rosiglitazone showed no cancer link, and the authors call the excess risk modest.
Drug
New 3D Mammography Significantly Increases Radiation Exposure, and Your Risk of Radiation-Induced Cancer
Dr. Mercola argues 3D tomosynthesis rebrands mammography while still requiring compression and delivering a higher radiation dose than a standard mammogram. He cites a 2011 Cochrane review finding screening led to 30 percent overdiagnosis and overtreatment.
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