Current Events

NEW YORK (Reuters) - Additional shortages of blood pressure drugs in the United States are possible following recent recalls related to traces of a probable carcinogen found in some versions a particular class of hypertension medicines, the U.S. Food and Drug Administration said on Friday.

The drugs, including valsartan, belong to a class of widely-used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. Valsartan is the generic of Novartis’ Diovan.

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Abstract

Background

Methods and Results

A systematic review and meta‐analysis of RCTs investigating paclitaxel‐coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all‐cause patient death. Risk ratios and risk differences were pooled with a random effects model.

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A drug company on Friday announced the recall of eight more lots of irbesartan blood pressure medication after testing revealed the drugs contained trace amounts of a carcinogen.

Prinston Pharmaceuticals recalled one lot of irbesartan tablets and seven lots of irbesartan HCTZ tablets. The medication contained unacceptable levels of the probable carcinogen nitrosodiethylamine, or NDEA, the company said.

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Medtronic PLC published an urgent medical device recall Thursday for nearly 157,000 dual-chamber pacemakers sold worldwide, after discovering a glitch that can cause some devices programmed in certain modes to temporarily lose their ability to pace the heart

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Members of the Sackler family, which owns the company that makes OxyContin, directed years of efforts to mislead doctors and patients about the dangers of the powerful opioid painkiller, a court filing citing previously undisclosed documents contends.

When evidence of growing abuse of the drug became clear in the early 2000s, one of them, Richard Sackler, advised pushing blame onto people who had become addicted.

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Food safety inspectors furloughed during the federal government shutdown will be returning to work beginning Tuesday — but still without pay — so that the Food and Drug Administration can begin to resume inspections of some high-risk foods at manufacturing and other processing plants, the agency’s commissioner said on Monday.

Food inspections — about 160 of which are conducted a week — have been halted since the federal government shut down and about 40 percent of the F.D.A.’s work force was furloughed.

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For the first time, Americans' odds of dying from an accidental opioid overdose are higher than from a motor vehicle crash, a data analysis found.

Injury Facts, an analysis from the nonprofit group National Safety Council, found the lifetime odds of dying by an accidental opioid overdose were 1 in 96, and the odds of dying by motor vehicle crash were 1 in 103.

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The Food and Drug Administration is shifting funds during the government shutdown to prioritize drug safety surveillance over pre-market drug review work, the agency’s commissioner has announced

“We’re making decisions across our portfolio to focus #FDA resources to key consumer protection functions. One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post market drug safety surveillance,” Dr. Scott Gottlieb said Tuesday in a tweet.

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Johnson & Johnson paid a steep price this year for claims that its celebrated baby powder was contaminated with asbestos. And its 2019 could be even worse.

A jury ordered the company in July to pay $4.69 billion to 22 women who blamed the talc-based product for causing their ovarian cancer. The prospect of similar judgments helped erase $45 billion in J&J’s market value, with the shares headed for their biggest annual loss in a decade.

A dozen patients in three states were hospitalized with serious bacterial infections after receiving injections of umbilical cord blood that purportedly contained stem cells, according to federal and state health officials.

The Food and Drug Administration said Thursday that it had issued a warning to San Diego-based Genetech Inc., the company that manufactured the treatment that contained E. coli and other dangerous bacteria.

The patients in Florida, Texas and Arizona became seriously ill after receiving injections and IV infusions of the product at orthopedic clinics, according to a report by researchers from the Centers for Disease Control and Prevention, the FDA and the Florida Department of Health.

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FRIDAY, Dec. 21, 2018 (HealthDay News) -- Patients should avoid a class of antibiotics called fluoroquinolones due to an increased risk of heart vessel tears associated with their use, the U.S. Food and Drug Administration warned.

"These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death," the agency said in a statement issued Thursday.

The risk for these ruptures rises with the use of fluoroquinolone antibiotics delivered by injection or as a pill, and the drugs "should not be used in patients at increased risk unless there are no other treatment options available," the FDA added.

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