The Survive and Thrive Boomer Guide

FDA should ban widely used, deadly gout medication, consumer group says

The U.S. Food and Drug Administration should immediately ban the widely used gout medication febuxostat because it poses unique, serious risks – including the risk of dying from cardiovascular disease – and provides no unique benefit, Dr. Michael Carome, director of Public Citizen’s Health Research Group, said Friday. Public Citizen petitioned the FDA to ban the medication in June 2018.

The FDA convened advisory committees in response to a request from Takeda Pharmaceuticals America, maker of the brand name febuxostat product Uloric, for approval to update the medication’s labeling to include results of a recently completed clinical trial. The trial, which involved more than 6,000 gout patients, showed that patients taking febuxostat were significantly more likely to die from cardiovascular causes compared with those receiving the much older gout medication allopurinol.

Initial clinical trials testing febuxostat prior to FDA approval linked the medication to possible increased risks of serious cardiovascular outcomes, including heart attack, stroke, and death. The FDA rejected the medication twice due to these safety concerns before approving it in 2009 on the condition that the manufacturer conduct the now-completed large, post-market clinical trial to further evaluate the cardiovascular risks.

Two more blood pressure medications recalled due to possible cancer risks

Teva Pharmaceuticals is recalling all lots of combination tablets featuring the drugs amlodipine and valsartan and another combination drug featuring amlodipine, valsartan, and hydrochlorothiazide due to an impurity detected.

The impurity is N-nitroso-diethylamine or NDEA, which has been classified as a probable human carcinogen, according to the U.S. Food and Drug Administration.

The combination tablets are used for treating high blood pressure. Teva hasn’t received any reports of adverse events signaling a potential link or exposure to valsartan, according to a statement from Teva posted by the FDA.

Blood pressure medication recalled due to impurities that could cause cancer

ScieGen Pharmaceuticals Inc. is recalling some lots of Irbesartan tablets because they may be contaminated with an impurity.

The impurity, N-nitrosodiethylamine, is classified as a probable human carcinogen by the International Agency for Research on Cancer.

The Irbesartan tablets recalled include 75 mg., 150 mg., and 300 mg. dosages and were manufactured by Aurobindo Pharma Limited.

Baby boomers focus on autumn opportunities

The weather here is changing, with temperatures dropping and brightly colored leaves beginning to pile up sidewalks so you can swish through them when you walk. 

There's a fall nip in the air, foreshadowing Halloween and the Day of the Dead – just around the corner.

Our boomer bloggers are writing about fall activities – how to cut a white pumpkin in memory of your loved ones, how to decorate for Halloween, and how a candidate meeting for the U.S. House of Representatives turned out.

Other topics include lottery fever, the routine use of antibiotics in livestock, and one way to slow atrial fibrillation.

Meryl Baer of Six Decades and Counting writes about these articles on the Best of Boomer Blogs #569. Click here to get the links to the articles. And be sure to leave a comment. Boomer bloggers love to hear from readers.

Copyright 2018, Rita R. Robison, Consumer Specialist

FDA considering approval of a super-potent opioid medication that will be abused and kill people, consumer group says

A U.S. Food and Drug Administration advisory committee has recommended approval of AcelRx Pharmaceuticals’ application for use of sufentanil sublingual tablets to treat moderate-to-severe acute pain in a medically supervised setting. It’s five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. The committee voted 10-3 last week for the medication to be approved.

However, Raeford Brown, M.D., chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee that made the recommendation, joined three Public Citizen staff in urging the agency to reject the application. Public Citizen is a consumer advocacy organization.

“I predict that we will encounter diversion, abuse and death within the early months of its availability on the market,” Brown said, adding strong opioids often are abused by medical personnel. “Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult.”

Burger chains make little progress in serving beef raised without antibiotics

Two burger chains, Shake Shack and BurgerFi, are serving beef raised without the routine use of antibiotics. They were the only restaurants to earn an “A” in the fourth annual Chain Reaction scorecard developed by six consumer and environmental groups. The vast majority of hamburger chains – 22 of the top 25, including top sellers such as McDonald’s – received an “F” grade because they lack established policies restricting antibiotic use in their beef supply chains.

“We should all be worried that so many restaurants are failing when it comes to antibiotic stewardship,” said Elise Orlick, director of the WashPIRG Foundation. “We need more burger chains to follow the lead of BurgerFi and Shake Shake and commit to protecting our life-saving medicines. Antibiotics are too important to lose and these companies can use their purchasing power to protect our health.”

The scorecard shows the lack of progress in the beef industry, the largest buyer of medically-important antibiotics among food animal sectors, in addressing antibiotic overuse. Public health experts warn that the widespread overuse of antibiotics for meat production is making these medications less effective by contributing to the creation and spread of drug-resistant bacteria called superbugs.

Corporation to pay $625 million for distributing contaminated drugs, including cancer drugs

Forty-four states and the federal government have reached an agreement with drug distributor AmerisourceBergen Corp. for illegal distribution of adulterated and misbranded drugs. ABC will pay the states and the federal government $625 million, of which $99.9 million will go to the states’ Medicaid programs.

“ABC placed corporate profits over patients’ needs, endangering the health of vulnerable cancer patients,” said U.S. Attorney Donoghue.

The settlement came after ABC’s AmerisourceBergen Specialty Group pleaded guilty to illegally distributing misbranded drugs in September 2017. ABSG agreed to pay $260 million in fines and payments.

Trump’s idea for reducing the costs of prescription drugs isn’t going to do much

U.S. Health and Human Services Secretary Alex Azar’s description recently of the Trump administration’s plan to lower prescription prices for Americans through Medicare negotiations is disappointing

“Compared to what the federal government could do to make medicines affordable, these are the leftovers of the small potatoes,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines Program. “And if handled poorly, the proposal could hurt patients.”

Azar is misleading people when he implies this is what Trump meant when he said Medicare could save billions by negotiating, said Maybarduk.

Attorneys general continue to legally challenge Trump administration on environmental and health issues

New York Attorney General Barbara Underwood

It’s fortunate that we have a group of state attorneys general who are willing to keep challenging President Trump and his cronies as they try to tear apart the structures of our government institutions. Here are three action filed Monday by attorneys general on behalf of consumers:

Clean water

Twelve attorneys general called on the Trump Environmental Protection Agency and Army Corps of Engineers Monday to abandon their proposal to dismantle the Clean Water Rule, a regulation adopted in 2015. The coalition said that the repeal of the rule and reestablishment of the old, ineffective regulations that the rule replaced wouldn’t be in accordance with law. The coalition calls on EPA and ACOE to stop the repeal.  

“New Yorkers’ health, environment, and economy depend on clean water,” New York Attorney General Barbara D. Underwood said. “Yet the Trump EPA continues to turn its back on the science and law, threatening New York’s decades-long fight to ensure our residents’ access to safe, healthy water.”

Three companies recall blood pressure medications due to possible contamination with a carcinogen

Several prescription drugs containing the active ingredient valsartan, used to treat high blood pressure and heart failure, are being recalled because they may contain an impurity, N-nitrosodimethylamine or NDMA, a probable human carcinogen.

The U.S. Food and Drug Administration said the presence of NDMA could be related to changes in the way the active substance was manufactured.

The FDA’s review includes investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them, and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.