Posts Tagged ‘FDA’

August25

Mesh to repair common pelvic condition should be pulled from the market

By: Dorry Samuels

Flickr photo by esc.ape(d)

A product used to treat a common problem afflicting women primarily of child-bearing age should be pulled from the market and recalled, Public Citizen told the FDA in a petition today.

WARNING: I’ll go into some graphic descriptions in this blog post. Have a weak stomach? Proceed at your own risk.

The condition is called pelvic organ prolapse (POP), and approximately 300,000 women in the U.S. were treated for it last year. In this condition, one or more of a woman’s pelvic organs (think bladder, rectum or uterus) bulges or descends into her vaginal cavity, sometimes past the opening of the vagina, because of weakness in the connective tissue and muscles that surround and support the pelvic organs.

Most women with POP have no symptoms. For symptomatic patients, treatment can involve surgical or non-surgical interventions; in surgical procedures, non-absorbable mesh often is implanted transvaginally (through incisions and punctures made through the wall of the vagina) with the intent of reinforcing the tissues around the pelvic organ that prolapsed and increasing the longevity of the repairs. Public Citizen estimates that approximately 67,500 of these procedures last year used non-absorbable mesh.

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Posted in: Consumer Protection, Health, Product Safety0 comments

August23

If you take Nexium, Prilosec or similar stomach acid-reducing drugs, you should read this

By: Angela Bradbery

Flickr photo by JudeanPeoplesFront

Have you ever taken Nexium, Prilosec or many other stomach acid-reducing drugs? Chances are, you or someone you know has. They are among the most widely prescribed drugs in the U.S.

But these drugs can cause long-term dependence and should carry the strongest possible warning label for a variety of dangerous adverse effects, Public Citizen told the U.S. Food and Drug Administration (FDA) in a petition sent today.

The drugs are proton pump inhibitors (PPIs), so-named because of the mechanism they use to shut off the production of stomach acid. An estimated  119 million prescriptions dispensed in 2009 and $13.6 billion in U.S. sales. About 1 of every 20 people in the developed world is taking the medications, which include Nexium, Dexilant, Prilosec, Prilosec OTC, Zegerid, Zegerid OTC, Prevacid, Prevacid 24-Hr, Protonix, Aciphex, Vimovo and numerous generic counterparts, most prominently omeprazole and pantoprazole.

Said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group:

These drugs are being prescribed far too commonly to people who shouldn’t be taking them. As a result, millions of people are needlessly setting themselves up to become dependent on PPIs while exposing themselves to the serious risks associated with long-term therapy. The FDA should act immediately to ensure that patients and physicians are adequately warned of these effects, and reminded of the many safer alternatives for common conditions such as acid reflux.

PPIs are approved to treat gastroesophageal reflux disease (GERD) – sometimes referred to as acid reflux – as well as gastric ulcers, erosive esophagitis and stomach bleeding associated with using non-steroidal anti-inflammatory drugs (NSAIDs). But evidence shows that after using PPIs for a month or more, patients who stop taking the drug make even more stomach acid than before they started the drug, a phenomenon known as rebound acid hypersecretion, which causes acid reflux symptoms to return even worse than before therapy.

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Posted in: Consumer Protection, Health, Pharmaceuticals, Product Safety, Regulation1 comments

August5

Weakening public safeguards means more people will be getting sick… or worse

By: Rich Robinson

The recent outbreak by a drug-resistant strain of Salmonella linked to ground turkey produced by a Cargill meat processing plant in Arkansas that made at least 80 people sick and killed one is another reminder that regulatory safeguards to inspect the food we eat play a crucial role in the health and well-being of our nation.

What makes events such as this even more frightening is that there are many in Congress who want to weaken the regulatory process. This might be “good” for business, but it would be horrific for the people.

Some are standing up and saying “no.” Rep. Rosa DeLauro (Conn.), senior Democrat on the Appropriations Committee’s health subpanel, called out her colleagues who have tried to slash food-safety funding, and warned such actions would lead to more people getting sick.

“By cutting their funding, we have limited their effectiveness and asked FDA and USDA to do more with less, and the impact of these cuts is starkly clear with this most recent recall,” DeLauro said.

In the third-largest food withdrawal in history, Cargill is recalling 36 million pounds of potentially contaminated meat, and it’s not the first time the food-producing giant has been forced to do so. In 2007, the company recalled 845,000 pounds of frozen ground beef patties linked to an outbreak of E. coli.

Foes of regulations want to make it easier for businesses to operate, but they ignore the protections regulations provide. Weakening such safeguards is a dangerous game and places all of us at risk – especially the most vulnerable to food-borne illnesses, the elderly and the young. Congress must not place corporate profits ahead of public safety.

Posted in: Health, Regulation, Uncategorized0 comments

August3

Superbugs

By: Rachel Lewis

See if this sounds like a good idea to you: Mix human antibiotics into the feed of animals at levels that are too low to knock out all disease causing bacteria in an attempt to quell safety concerns about the unsanitary conditions at mega-farms. Not particularly brilliant, right?

Now, see if this makes sense: Study this practice at mega-farms, conclude in 1977 that continued use of this practice could promote “superbugs,” resistant strains of bacteria that pose risks to human health, then ignore your own findings and conclusions for the next 34 years. Sound crazy? Well, it is. And yet, this is exactly what has been happening, or perhaps I should say what has not been happening, right here in the good old U S of A.

The U.S. Food and Drug Administration (FDA) has known for three decades that feeding low levels of certain antibiotics to healthy animals poses a threat to human health.

How much of a threat are we talking about here? Well, do you consider AIDS a threat? Then, consider this: In 2007, the Journal of the American Medical Association (JAMA) reported on 2005 data on MRSA, a drug-resistant aggressive variant of staph bacteria that killed more people in the U.S. than AIDS.

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Posted in: Consumer Protection, Litigation, Pharmaceuticals, Product Safety, Regulation, Uncategorized0 comments

July25

FDA commissioner talks dangerous drugs, innovation and regulations at Public Citizen

By: Dorry Samuels

FDA commissioner Margaret Hamburg speaks with Public Citizen president Robert Weissman

FDA commissioner Margaret Hamburg has a lot on her plate, especially considering the wide array of issues her agency covers. Luckily, she was able to chisel some time out of her busy schedule to fit in a discussion at Public Citizen.

She spoke today about a number of these topics, but divulged that she is concerned about two concepts: that the FDA is seen as a bureaucratic agency impeding innovation, and the role and influence Congress is exerting in the FDA’s budgetary process.

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Posted in: Congress, Consumer Protection, Health, Pharmaceuticals, Product Safety0 comments

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