Amgen’s anemia drugs have been embroiled in controversy about their safety for several years as evidence has mounted that their overuse can cause heart attacks or strokes or make cancer worse. Now comes yet another problem, though presumably a temporary one.

Amgen announced on Friday morning that it and Johnson & Johnson were recalling various lots of their anemia drugs, Epogen and Procrit, because extremely thin, barely visible glass flakes had been found in the vials.

Amgen said the particles could cause clots and other problems if the drugs were given by intravenous infusion, or lumps and immune system reactions if injected under the skin.

The company said it had received no complaints or had heard of no problems that could be “directly attributed to’’ the glass particles, however. A spokeswoman for Amgen, Emma Hurley, said the company’s evaluation “found a low potential to impact patients.’’

Amgen said the recall was being done in coordination with the Food and Drug Administration.

Both drugs are the same substance, a protein called erythropoietin, or epoetin alfa, which is made by Amgen in Puerto Rico. Amgen sells the protein as Epogen for the treatment of anemia in kidney dialysis patients.
Johnson & Johnson sells it as Procrit for other uses, like anemia caused by kidney disease that does not yet require dialysis and for anemia caused by cancer chemotherapy.

Ms. Hurley said Amgen did not anticipate that the problem would affect the availability of Epogen and would not have a material financial impact on Amgen. Johnson & Johnson also said supply of Procrit should not be affected.

Amgen discovered the flakes, Ms. Hurley said, during a recent inspection of vials of the drug. The flakes were formed by the interaction of the drug formulation with the glass vials over the shelf life of the product.

Amgen has now reduced the shelf life to either 12 or 15 months, depending on the type of vial, from 36 months.

No recent change in the formulation of the drug would explain the problem, she said. That raises the possibility that the problem has been occurring undetected for a some time. Epogen was first approved in 1989.

A third anemia drug, Amgen’s Aranesp, is a slightly different protein and is made separately from the other two.

Interactions between a drug and a vial are not unknown and can be serious. Several years ago, dozens of patients in Europe who were treated with Johnson & Johnson’s Eprex — basically the European version of Procrit — developed a serious condition called pure red cell aplasia, which left them dependent on blood transfusions. Johnson & Johnson eventually attributed the problem to a reaction between the drug formulation and the stoppers used in the vials.

The anemia drugs have all been huge sellers with sales of two billion dollars a year or more. But concerns have arisen in recent years that overuse of the drugs has contributed to problems like heart attacks and strokes and, in cancer patients, a worsening of the cancer.

Sales, particularly for use in treating cancer patients, have plummeted as the Food and Drug Administration has put extra warnings on the drugs’ labels and as Medicare has become more restrictive in paying for the drugs.

The F.D.A. will hold another advisory committee meeting on Oct. 18 to review the latest findings of possible harm to patients with kidney disease from the drugs.

Source: http://prescriptions.blogs.nytimes.com/2010/09/24/amgen-and-johnson-johnson-recall-anemia-drugs/

OTTAWA - Health Canada is advising Canadian retailers not to sell and consumers not to use manual toothbrushes labelled as Oral-B Classic 40 Medium, as they were found on the Canadian market and may pose harm to consumers. Health Canada has received one incident report of the bristles of the toothbrush, purchased at Dollarama L.P., becoming dislodged and stuck in the user’s throat. The individual did not require medical care, but toothbrushes with bristles that are insufficiently fastened may present a choking hazard.

Procter & Gamble Inc., the manufacturer of Oral-B toothbrushes, has collaborated with Health Canada, and has examined samples of manual toothbrushes labelled as Oral-B Classic 40 Medium. Procter & Gamble Inc. has advised Health Canada that the toothbrush is a counterfeit product and they have not manufactured the Oral-B Classic 40 Medium manual toothbrushes worldwide in almost a decade.

Health Canada has been working with Dollarama L.P. to ensure that these toothbrushes are removed from sale. Dollarama L.P. has voluntarily recalled all manual toothbrushes labelled as Oral-B Classic 40 Medium being sold at their stores throughout Canada. Read the rest of this entry »

Toxic Ingredients in Antiperspirant, that affects Brain Health, and is known to cause Alzheimer’s.

Aluminum, a common ingredient in deodorant and antiperspirant, is often linked to Alzheimer’s and brain disorders and is a possible risk factor in breast cancer.

In a culture where being well-groomed and attractive are almost a necessity, dependence on deodorant and antiperspirant is a must. But few know the health hazards present in the everyday underarm cosmetic. Beyond the synthetic fragrances and toxic ingredients found in most personal care products, antiperspirant and deodorant are loaded with aluminum compounds that have been linked to Alzheimer’s disease and brain disorders, respiratory disorders, and possibly cancer.

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Organic – any product that was grown or created without the use of chemical pesticides, fertilizer, hormones, antibiotics, or artificially-derived chemical additives. Organic plant products do not allow for genetic engineering or the use of radiation. Organic wines do not have added sulfites, only naturally-occuring, trace amounts. (Wines from Europe are, by nature, organic). When the term “organic” is found on food products, at least 95% of the product uses organic ingredients. Read the rest of this entry »

DON’T BE FOOLED BY THE LUSH LOOK OF PRODUCTS (Pun Intended).

Organic certification is the only way you can be sure a company’s product truly complies with organic standards. No certification = No proof = Not organic.

Sales of organic products are on the rise, and growth rates average over 20% per year. Because of this, many companies are trying to catch this wave by offering “organic” products for sale. But what does “organic” mean? How do organic standards apply to soap and skin care products?

The USDA’s National Organic Program (NOP) provides the benchmark, global standard for defining organic. Within the NOP, there are three levels of certification. A product’s classification is based on the total percentage of its organic ingredients (without counting water or salt). Here’s what they mean, and then we’ll discuss how the standards apply to soap and skin care.

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