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Posts with tag FDA

Eli Lilly's Evista cancer drug approved by FDA

It's interesting when a drug is re-purposed into something aimed at fighting cancer, but that is what has happened to Evista, a prescription drug made by Eli Lilly which was originally for osteoporosis patients.

The FDA has officially approved Evista for use in breast cancer patients as of late this week, although the drug will now come with a box warning advising patients of a heightened risk for stroke by taking the drug.

I'm not sure -- are some drugs worth the possible benefits when certain side effects can be just as bad as what is trying to be treated?

Merck and FDA agree on cancer drug trial

The Food and Drug Administration and pharmaceutical giant Merck have agreed on a "special protocol assessment" that will determine if the cancer drug oral deforolimus for patients with cancer of the body's connective tissue(s).

Merck and partner Ariad will begin patient enrollment for deforolimus later in September, with progression-free survival being the endpoint of the Phase III trial. The second endpoint? How about overall patient survival?

Since there are currently very few effective treatments for sarcoma cancers, my bet is that this new drug will be on the market the date the Phase III trial officially concludes.

FDA proposes suncreen rules and cancer warnings

The FDA proposed a new regulation on Thursday governing retail sunscreens, including adding a new label warning consumers about the risk of skin cancer linked to sun exposure.

The FDA proposed testing and rating a product's level of ultraviolet A protection. UVA is responsible for tanning and UVB for burning. The FDA hopes to clarify that both UVA and UVA are dangerous. Currently, the sun protection factor or SPF rating, only indicates the level of UVB protection.

The proposed warning would remind consumers that sunscreen use should not be used as a reason to extend time spent in the sun and that UV exposure increases the risk of skin cancer, premature skin aging and other damage. The new UVA rating system would use a scale of one to four stars, with four stars representing the highest UVA protection available in an over-the-counter sunscreen.

Anything that can help us increase our understanding of sun and skin health is a step in the right direction.

Information you need to know about generic drugs

A generic drug is exactly the same dosage, safety, strength and quality as a brand named drug. Generic drugs also do not take longer to work in the body, again, its the same ingredients as the name you are more familiar.

The reason generic drugs are cheaper is because the makers of these drugs don't have the costs of the original developer of the drug. When the patent on the developer expires, 20 years, other manufactures can introduce competitive generic versions to the FDA for approval. This also creates greater competition in the industry once generic drugs are approved and keeps costs lower.

A great place to go is here for more information on your generic drugs.

FDA issues new safety rules for vitamins and supplements

Millions of Americans use vitamins and supplements as a measure of protection against disease, including cancer. Some patients integrate such supplements into their treatment plans as a complement to traditional medicine.

Last Friday, the FDA said it will phase in a new rule that all manufacturers of vitamins, herbal and other dietary supplements will have to test the ingredients of such products for safety. This rule is intended to ensure that the ingredients on the label match up with the ingredients in the supplement and that no contamination has occurred.

According to an article in the Washington Post, Dr. Sidney Wolfe, director of the Public Citizen's Health Research Group, is still not satisfied. Dr. Wolfe said, "You still don't have to show the product is safe. You don't have to prove it works."

While there still might be a lot of work to be done on this issue, this action is a step in the right direction.

Diet drug Xenical renamed Alli, still a cancer worry

Prescription weight-loss drug Xenical hit drugstore shelves on Friday with a new name -- Alli (pronounced: "Al-eye") and with a new non-prescription strength. The newly-named drug is to be more effective with less unpleasureable side effects. Still, there's a problem surrounding this drug, regardless of its name. It's thought to cause colon cancer.

The nonprofit group Public Citizen says Alli, made by GlaxoSmithKline, has been shown in mice studies to cause pre-cancerous lesions in the colon. Since there are no long-term studies on humans, this group believes the FDA should not have approved the drug for non-prescription use. It's not clear whether or not the pre-cancerous spots will lead to colon cancer but the mere suggestion that it might is enough, says a Public Citizen spokesperson.

"What we do know is that these lesions occur much more frequently in people who do get colon cancer," he said. "Why do we recommend that everyone get a colonscopy at the age of 50? Because you pick up on these polyps when you do one. And, even though not all of the polyps are pre-cancerous, no (doctor) does a colonscopy without removing every single polyp that is found. And you do this because you know if you don't, it greatly increases the chances of getting cancer."

Continue reading Diet drug Xenical renamed Alli, still a cancer worry

FDA gives stamp of approval for kidney cancer drug

New cancer drug Torisol was approved on Wednesday by the FDA for use with renal cell carcinoma, an advanced form of kidney cancer.

Torisol, also known as temsirolimus, is an enzyme inhibitor made by Wyeth Pharmaceuticals and has shown promise for prolonging patient survival. It's the third kidney cancer drug approved in the past 18 months -- the other two are Nexavar, intended to delay disease progression, and Sutent, for tumor size reduction.

Many kidney cancer patients are cured by surgery. About 35 percent of patients, however, experience a recurrence or a spread of the disease. Until just recently, there were no effective drugs to control these issues. Now there are several -- and Torisol is the one showing modest improvement in survival for patients with the most advanced tumors. Further study will indicate whether or not the drug is useful for patients with less extensive metastatic disease.

Sunday Seven: Seven catches while fishing for truth

I'm still on a quest for guidance on the whole fish topic. The same few questions keep cycling through my head. How often should I eat fish? What kind of fish should I eat? What are the real health dangers surrounding fish consumption? I keep searching for answers. And now and then, I catch some good advice about the topic.

If you find yourself floundering at times, like me, here are seven tips you might find helpful.
  • The National Academy of Sciences, the American Heart Association, and the World Health Organization all encourage regular fish consumption. Sure, there are legitimate concerns about environmental issues, but experts still say the benefits of eating a variety of fish far outweigh the risks. Eating fish protects the heart and reduces the risk for Alzheimer's disease, arthritis, strokes, depression, bipolar disorder, and our favorite topic here at this site: cancer.

Continue reading Sunday Seven: Seven catches while fishing for truth

Cervical cancer vaccine, Cervarix, slowed by FDA

The Food an Drug Administration is not going to grant a priority review to GlaxoSmithKline's experimental cancer vaccine Cervarix. Adding pressure is recent controversy surrounding its diabetes drug Avandia.

Cervarix will now have to go through a standard 10-month review, instead of going the fast-track route. GlaxoSmithKline is defending its diabetes drug after a study published in the New England Journal of Medicine said that those taking the drug are at greater risks of heart attacks.

GlaxoSmithKline expects to market the drug Cervarix in the United States sometime in 2008.

FDA's Labelman says: Make your calories count

The Food and Drug Administration (FDA) is making it easier for consumers to read food labels. With a quick stop at a website called Make Your Calories Count, we can all learn how to better decipher and truly understand the numbers we find printed on the back of food items.

The FDA interactive site, featuring a cartoon character called Labelman, provides consumers with information related to healthful diets and calorie management. There are exercises, quizzes, and a training module available for download and printing.

The program, which presents two nutrients that should be limited (saturated fat and sodium) and two that should be consumed in adequate amounts (fiber and calcium), may be just the resource we need in our pursuits of better health and disease prevention.

Drug for metastatic prostate cancer ready for approval

The FDA was given the okay by their panel of advisors to approve the drug Provenge, an immunotherapy that stimulates the immune system to help fight cancer cells.

The drug is designed for patients with metastatic prostate cancer who stop responding to hormonal therapy. The drug triggers the immune system to recognize a particular protein that is found on about 95 percent of all prostate cancer cells. When the immune system identifies the protein, it attacks the cancer cells.

The drug has shown in two previous trials that it increases survival in patients that have prostate cancer that has spread to other parts of the body.

Thought for the Day: Sweet news from the FDA

The Food and Drug Administration (FDA) has something important to say about the sugar substitute aspartame.

Think about this:

Italian researchers concluded in 2005 that aspartame causes cancer. But Laura Tarantino of the FDA Office of Food Additive Safety concludes after a review of the study data that the low-calorie sweetener is not a carcinogen.

A similar review by the FDA's European counterpart agrees. There is no evidence this substance, used for 25 years to sweeten soda, gum, dairy products, and some medications, causes cancer.

Italian researchers say they will release their latest aspartame study results on Monday.

Thought for the Day: The facts on fish

Ever wonder what fish to eat, what fish to avoid, what fish is healthy, what fish is cancer-causing? I do.

I'm looking into this whole fish thing. And while my search for information is in no way exhaustive and my findings are far from conclusive, I have found some interesting fishy facts and figures.

Think about this:

Fish definitely has health benefits. It's low in fat, high in protein, and rich in omega-3 fatty acids. Americans love this. How do I know? Because on average, each of us eats a record 16.6 pounds of fish every year. Our intake of shrimp and salmon has doubled, in fact, since 1994.

Fish definitely has its drawbacks too. Headlines repeatedly warn us of dangerous contaminants in lakes, rivers, and oceans. Don't forget about mercury, the biggest fish health hazard. It's been linked to neurological problems in developing fetuses and children, making consumption of shark, swordfish, tilefish (aka golden snapper or golden bass), king mackeral, canned albacore tuna, and tuna steaks a no-no for hoards of women and children.

For just about everyone else, the benefits of eating moderate amounts of seafood greatly outweigh the risks. Just watch out for those PCBs (polychlorinated biphenyls) -- possible carcinogenic chemical compounds that end up in some seafood.

To avoid PCBs, steer clear of farmed salmon which contains high levels of these compounds or limit your intake to less than one single eight-ounce meal per month. Opt for the wild variety of salmon to avoid this concern altogether. Or take the side of the FDA. Their reports say salmon is a powerhouse when it comes to protecting heart and developing cancer from this source is much lower than the risk of heart disease.


Source: Good Housekeeping, April 2007

FDA needs more time with Wyeth kidney cancer drug

The Food and Drug Administration (FDA) will take an additional three months to review Wyeth's kidney cancer drug Torisel -- the first of five new medications the company plans to introduce this year.

The FDA needs more time to investigate data on tumor growth in patients taking Torisel. If all goes well, the drug will be one of only three to effectively hold off incurable kidney cancer. The other two drugs are Pfizer's Sutent and Bayer AG's Nexavar.

Robert Ruffolo, president of Wyeth Research, says he is encouraged by the review process so far. And he is optimistic about launching the product in late 2007.

Studies show Torisel, which will cost patients about $30,000 per year, prolonged survival by 50 percent in those faring poorly with kidney cancer. The sickest kidney-cancer patients were essentially kept alive for 10.9 months, compared with 7.3 months with interferon drugs. Torisel also postponed tumor growth for 5.5 months. This is 77 percent longer than with interferon.

Sutent and Nexavar, both on the market since last year, also slow tumor growth. All three kidney-cancer medicines are of the variety that block the growth of cancer cells -- different from standard chemotherapy which kills tumors and harms nearby tissues too.

Wyeth is relatively new to the oncology market. And soon, the company hopes to launch three more cancer drugs. One, called CMC-544, treats non-Hodgkin's lymphoma. Another, SKI-606, is for chronic myelogenous leukemia. And the third, HKI-272, is for breast cancer.

About 51,000 Americans will be diagnosed with kidney cancer this year.

Newly released recommendations for HPV vaccine

The Human Papillomaviruses (HPV) vaccine called Gardasil can protect from the infection of four types of the HPV virus. Two of these types cause up to 70 percent of all cases of cervical cancer.

Recommendations were released by the Advisory Committee on Immunization Practices (ACIP) regarding the use of Gardasil. The FDA approved Gardasil in June 2006.

The role of ACIP is to advise the Director of the Centers for Disease Control and Prevention (CDC) and the Secretary of the Department of Health and Human Services (HHS) about vaccine usage and vaccine-preventable diseases.

The recommendations published by the ACIP:

  • Recommended age for routine vaccination of girls is 11-12 years.
  • The vaccine can be given to girls as young as 9 years.
  • Catch-up vaccination is recommended for girls and women between the ages of 13 and 26 years who were not vaccinated previously or who did not complete the full vaccine series (the vaccine is administered in three separate doses).
  • Routine cervical cancer screening remains important following vaccination.

The ACIP's recommendations can influence policy and practice, but are not directly linked with school and daycare entry laws. These laws are made by individual states.

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