Articles Posted in FDA

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pills2The Food and Drug Administration (FDA) has been considering making changes to its labeling rules with regard to 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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Would you swallow a digital pill? Sounds crazy, but true. The U.S. Food and Drug Administration (FDA) has approved the first digestible device. The device is currently only approved for use with placebos, but the developing company, Proteus Digital Health, is hopeful that it will be approved in the near future for other drugs.
The microchip, made of silicon, is small, very small – approximately the size of a sand-particle. It can be embedded in drugs to monitor patients’ response to treatment. When swallowed, the pill generates slight voltage, which in turn sends a signal to a patch worn by the patient, which transmits relevant information to a healthcare provider’s cell phone. It is anticipated that these pills could be used to treat everything from drug-resistant tuberculosis to diabetes.
Really incredible technology that hopefully is the future.

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The FDA has announced the recall of 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 treatment for male Erectile Dysfunction (ED). 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, due to 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 has announced today the recall of Vagifresh Ball and Vagifresh Gel. An analysis by the FDA has found that Vagifresh Gel contains benzocaine, an active ingredient for many anesthetic drug products. An analysis of Vagifresh Ball found the product to contain bacteria including Staphylococcus lentus, S. sciuri, Bacillus Lantus, Alloiococcus otitis, Aerococcus viridans, Aeromonas salmonicid, Gemella spp, and Leuconostoc spp.

The FDA has further determined that marketing material for these products contained unsubstantiated therapeutic claims related to various gynecologic conditions that could have caused women taking these products from seeking appropriate medical care for potentially serious medical conditions.

These products, marketed as cosmetics, are applied by inserting deeply into the vagina for a prolonged period of time. Sold in herbal stores, beauty shops, drug stores, the internet, and by mail order. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid, though this recall does not involve Vagifresh liquid.

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An advisory committee to the Food and Drug Administration has met to discuss popular birth control pills such Yas and Yasmin, and has concluded that the information on the labels should be strengthened.

Currently, the labels suggest that these contraceptives have blood clot risks similar to those of other birth control pills that combine estrogens and progestins. The panel, which voted 21 to 5 in favor of changing the labels, has said the labels should be strengthened to include more information about the possibility that the pills could lead to greater risk of blood clots. They stopped short of recommending that they warn that the drugs are more likely than other contraceptive pills to cause blood clots. Instead, the experts suggested that the labels note that the evidence about blood clots is conflicting.

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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, Pradaxa and warfarin were compared, 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 a 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 lungs or blood vessels, which can be fatal.
These popular drugs use a version of a female hormone which 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 hid 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 lock down 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 a 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 companies sales of its RUO or IUO products if the company knows or has 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.