Articles Posted in FDA

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The surgical implant manufacturer Exactech recently announced a recall of all its Optetrak® implant systems used in total knee replacement surgeries since 2004. The recall came after the company discovered that a problem with the product packaging was causing the polyethylene insert component in the Optetrak implants to degrade not function properly. This defect is causing the Optetrak knee implant systems to prematurely fail which ultimately requires patients to undergo additional revision surgery.

Individuals who had the Optetrak system implanted and suffered premature failure due to this defect can file a product liability lawsuit against Exactech and potentially recover financial compensation for their pain and medical bills. Our firm is currently accepting Optetrak implant failure cases from patients who suffered a premature failure to their knee replacement implant and had to undergo revision surgery.

Opterak Exactech Recall Lawsuit –  June 2022 Update

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In recent years, studies have found an association between paraquat, an herbicide, with several adverse health effects.  Most notably, the concern is Parkinson’s disease.  An Illinois man filed a new suit in state court alleging that his decades of paraquat exposure caused him to develop Parkinson’s.  There are many more Paraquet lawsuits expected in 2021.  Let’s unpack what these cases are about.

Paraquat is toxic

Paraquat is an extremely toxic herbicide.  Nobody is really arguing this point. The herbicide is primarily used for controlling weeds and grasses. It is manufactured by agribusiness giant Syngenta.

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pills2The Food and Drug Administration (FDA) has considered changes to its labeling rules regarding generic drugs.  The changes could provide generic drug users with more protection.

Currently, those that have been injured by a brand-name drug can win compensation from the manufacturer if it can be shown that the drug was unreasonably dangerous or that the warning label did not disclose the risks properly.  Those injured by a generic medicine?  Not so much.  Those injured by a generic medicine can’t hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.  Crazy, huh?

All of that could be changed by a new rule that the FDA expects to formally propose in September.  The new rule would “revise and clarify procedures for changes to the labeling” of approved drugs.  This will include both brand names and generics.  This change would either enable or require (not yet clear based on the information provided by the FDA) drug makers to announce possible changes to their warnings while the FDA is considering the warning.

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The FDA has announced the recall of a single capsule packet RegenErect, as it has been discovered that an active drug ingredient is not listed on the label.
Labeled as a dietary supplement, it has been determined that RegenErect contains Tadalafil, an FDA-approved drug used as a treatment for male Erectile Dysfunction (ED). The use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Erectile Dysfunction is a common problem in men with these conditions, and as such, consumers may seek these types of products to enhance sexual performance.

RegenErect has been sold over the internet to consumers in the United States of America and Puerto Rico and given as samples at public events. It is a blue capsule and sold individually in foil packets with a UPC code of 816860010055.

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A recall has been announced of seven lots of Norgestimate and Ethinyl Estradiol Tablets, because of a packaging error, causing the possibility for the pills to be out of sequence.

The affected pills are the Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. It has been determined that the blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation. This has additionally caused the lot number and expiration date to be visible only on the outer pouch.

This product is used as an oral contraceptive indicated for the prevention of pregnancy. Though the packaging defect does not pose a health risk, the packaging error can cause the daily regimen to be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

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The FDA is evaluating post-marketing reports of serious bleeding events in patients that are taking Pradaxa (dabigatran etexilate mesylate). Pradaxa, a blood-thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), contains a drug label that warns about significant and sometimes fatal bleeds, bleeding that may lead to serious or even fatal outcomes.

In a large clinical trial involving 18,000 patients, they compared Pradaxa and warfarin with major bleeding events occurring at similar rates with the two drugs.

The FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

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Birth control drugs such as Yaz and Yasmin are under new scrutiny from safety regulators. These and other similar drugs, once heavily promoted as having fewer side effects and the ability to clear up acne, could be ordered by the Food and Drug Administration (FDA) to provide new warning labels, as research is now suggesting that newer birth control formulations are more likely to cause blood clots than older drugs. While the increased risk is slight, it is considered significant because blood clots can cause heart attacks, strokes, and blockages in the lungs or blood vessels, which can be fatal.
These popular drugs use a version of a female hormone that appears to reduce side effects that are found in older drugs, effects such as bloating and mood swings. But, the FDA is also reviewing research on clot risks associated with Johnson & Johnson’s weekly Ortho Evra patch, which uses a different version of the female hormone progestin.
Millions of women have used these products since they introduced a decade ago, but recent studies comparing the medical histories of women taking the new drugs to older ones suggest a slightly higher risk of blood clots in the legs and lungs. While all hormone-based drugs increase the risk of clotting, the matter is further complicated in that clots can be caused by factors such as smoking, obesity, or family history.

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Drug companies love to hide behind the FDA’s skirt. I don’t think the FDA is a bad organization. And it is getting better (I think). But we get almost weekly evidence that the FDA is not the lockdown gatekeeper that pharmaceutical companies pretend that it is.

This week’s evidence is revealed in the New York Times. In an audit of 17 FDA food recalls, the FDA often failed to follow its own rules in removing dangerous imported foods from the market. Keep in mind the level of screw up here: failure to follow your own rules after you know there is a problem. This audit concluded that government food officials are often sloppy and inattentive in their efforts to ensure that bad food is taken out of our mouths quickly.

The FDA is not a joke or a laughing stock. When it is sticking its chest out, the FDA implicitly but seductively suggests it can protect us. But its reach exceeds its grasp. It can’t deliver. Even under the best-case scenario with the greatest government regulation in the history of the world, it still can’t deliver.

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FDA is poised to limit the sale and distribution of “Research Use Only” (RUO) and “Investigational Use Only” (IUO) products, issuing draft guidance to that effect on Tuesday.

RUO products are usually in the laboratory research phase of development or are used as basic scientific research. But some companies sell these products when they know or should know that they are being misused diagnostically. Now, the FDA will require that companies only sell their RUO or IUO products if they know or have reason to know that the product is actually being used diagnostically. In other words, no more turning a blind eye to what you know or assume the company’s purpose for a product. The “hey, we make no diagnostic claims are being made” skirt is off.

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In just an hour, the FDA’s Office of Compliance, Division of New Drugs and Labeling Compliance (DNDLC) will present a webinar entitled, “Marketed Unapproved Drugs.” The webinar will discuss (1) the history of drug regulation in the United States, (2) the public health risks associated with unapproved drugs in the market and FDA’s Unapproved Drug Initiative, (3) and will identify tools to help determine the approval status of prescription drug products.

No word yet on whether Johnson & Johnson will require everyone at J&J who has ever even heard the word “Topamax” to attend.

Okay, that was a weak effort at a joke. I was trying to slide in a “marketing Topamax for everything but the common cold” jab but it does not really fit. You sometimes can’t fit in the joke with the story. But check out the webinar.