Generic Norvasc (amlodipine) Might be Available Next Week

truth about enzyte

Generic forms of Pfizer Inc.'s blockbuster Norvasc blood pressure drug will likely be launched by next week -- six months earlier than expected -- after a U.S. appeals court decided Pfizer's patent on the drug is invalid, analysts said.

See full story: Court rules against Pfizer on Norvasc patent

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Plant Estrogen May Cut Breast Cancer
A diet rich in estrogen-like compounds found in flaxseed, tea, and truth about enzyte many plants may help curb breast cancer after menopause.

Full Article: Plant Estrogen May Cut Breast Cancer

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Thursday, March 22, 2007

truth about enzyte

Alzheimer Disease Toll Rising

More than 5 million people in the U.S. now live with Alzheimer disease and by mid-century, with the aging of the population, that number could reach as high as 16 million, warns a report released Tuesday by the Alzheimer's Association. Based on previously published estimates and new extrapolations, the report says:
Alzheimer disease was the seventh leading cause of death in 2004.
While mortality rates for heart disease, stroke, and breast and prostate cancer all declinedbetween 2000 and 2004, the death rate from Alzheimer rose 33%.
In 2005, Medicare spent $91 billion on beneficiaries with Alzheimer disease or other dementias. That cost is projected to increase to $160 billion in 2010 and $189 billion in 2015.

Alzheimer's Association report (Free PDF)
Alzheimer's Association fact sheet (Free PDF)
Alzheimer's Association press release (Free)

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Merck Seeking FDA Approval for Arcoxia (etoricoxib), a COX-2 Inhibitor
In a bid to recapture a piece of the arthritis pain-relief market, Merck & Co. is seeking government approval for Arcoxia, a chemical relative of Vioxx, the drug pulled off drugstore shelves in 2004 after being linked to heart attacks. In its last full year on the market, Vioxx brought in about $2.5billion in sales. If the Food and Drug Administration approves Arcoxia, Merck could recoup some of those sales.

On April 12 an FDA advisory panel will consider approval of Arcoxia for osteoarthritis; it is already sold in 62 other countries. The FDA usually follows advisory panel recommendations.
Arcoxia, like Vioxx, belongs to a group of drugs called COX-2 inhibitors, which block an enzyme that causes arthritis pain. Celebrex is the only COX-2 drug still on the market.

A Merck study of 34,000 patients compared Arcoxia to diclofenac. Merck says Arcoxia users had somewhat fewer heart attacks than diclofenac users but were more likely to develop hypertension. Arcoxia also led to fewer upper gastrointestinal problems, Merck says.

See Full Article
New Drug for Arthritis?: Merck Seeking FDA Approval for Arcoxia, a Chemical Relative of Vioxx, Which Was Linked to Heart Attacks

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Study: Morphine Kills Pain -- Not Patients
U.S. scientists have found the belief that morphine is a lethal drug that causes death when used to control a dying patient's pain is a misconception. Two studies at the Cleveland Clinic's Taussig Cancer Center, led by Professor Bassam Estfan, focused on patients in a specialist palliative care in-patient unit. The patients, all with severe cancer pain, were treated with morphine. Their vital statistics were monitored before and after the pain was controlled. Doctors should feel free to manage pain with doses adjusted to individual patients so that the patients can be comfortable and be able to live with dignity until they die.

The studies appear in the journal Palliative Medicine.

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Friday, March 16, 2007

Actos (pioglitazone) and Increased Risk of Fractures
Takeda and the Food and Drug Administration notified health care professionals of recent safety data concerning pioglitazone-containing products. The results of an analysis of the manufacturer’s clinical trial database of pioglitazone showed more reports of fractures in female patients taking pioglitazone than those taking a comparator (either placebo or active). The majority of fractures observed in female patients were in the distal upper limb (forearm, hand, and wrist) or distal lower limb (foot, ankle, fibula, and tibia).

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Colon Cancer Screening Saves Lives, Money
Colon cancer is the number two cause of cancer deaths in the U.S. for both men and women, but many lives could be saved if more people took advantage of colon cancer screenings. The American Cancer Society recommends that all those age 50 and over get screened for colon cancer, but still only half of those who should do. Not only do colonoscopies save lives but they save money as well. The American College of Gastroenterology found that treating a patient with early stage colon cancer costs about $30,000, while treating someone with advanced colorectal cancer is estimated at $120,000 per patient.

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Coreg (carvedilol) New JACC Analysis Details Cardiovascular Protective Benefits of Carvedilol in Heart Failure Patients
Patients with heart failure who received the heart medication carvedilol suffered fewer heart attacks and strokes and were less likely to die of these and other vascular events than patients prescribed another beta blocker, metoprolol tartrate, according to a retrospective analysis of COMET (the Carvedilol or Metoprolol European Trial) published in the March 6th issue of The Journal of the American College of Cardiology.

Study investigators looked at whether the effects on vascular events contributed to the beneficial effect of carvedilol in the COMET trial, the longest and largest mortality trial comparing beta-blockers in heart failure patients. Among its key findings, the analysis documented that carvedilol reduced the risk of heart attacks, unstable angina, or stroke by 19% (p = 0.017). During the study, 106 of the 160 patients on metoprolol tartrate who had a nonfatal heart attack or stroke later died, while 61 of 124 patients on carvedilol who had a nonfatal heart attack or stroke later died.

COMET was a double-blind, randomized parallel group study designed to compare the effects of carvedilol with those of metoprolol tartrate on the risk of death and hospitalizations in patients with congestive heart failure. The study included more than 3,000 patients with heart failure primarily due to ischemic or dilated cardiomyopathy. Study participants were followed for an average of 58 months. According to COMET investigators, the study results suggested that the use of carvedilol in patients with heart failure extended median survival by 1.4 years.*

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Medicare to Review Use of Anemia Drugs
Medicare officials plan to review the use of three anemia drugs in light of concerns about potentially harmful side effects. The review could determine whether Medicare continues to pay for Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit.

The New York Times/Bloomberg

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Sleep Drug Product Labels to Change

The U.S. Food and Drug Administration has ordered manufacturers of drugs used to help people sleep to strengthen warnings about potential risks. The FDA said all manufacturers of sedative-hypnotic drug products -- a class of drugs used to induce or maintain sleep -- must strengthen their product labeling to include stronger language about such risks as severe allergic reactions and complex sleep-related behaviors. Those behaviors include sleep-driving, which is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

The FDA also ordered the pharmaceutical companies to notify healthcare providers about the new warnings. The medications of concern to the FDA are: Ambien/Ambien CR, Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal and Sonata.

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A Potential Drawback to Daily Aspirin
Men who take doses of acetaminophen or nonsteroidal anti-inflammatory drugs like ibuprofen 6 or 7 times a week increased their risk for high-blood pressure by more than one-third, according to a study in the Archives of Internal Medicine. The same use of aspirin increased the risk by 26%, researchers said.
As Reported by The New York Times

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FDA Approves Tykerb (Lapatinib) in Combination With Xeloda (Capecitabine) for the Treatment of Advanced or Metastatic Breast Cancer
GlaxoSmithKline plc announced that the United States Food and Drug Administration (FDA) approved TYKERB (lapatinib), in combination with Xeloda(R) (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. TYKERB was granted Priority Review by the FDA in November 2006.

This approval was based on the pivotal Phase III trial of 399 patients which showed that the median time to disease progression as assessed by independent reviewers was 27.1 weeks on the combination of TYKERB and capecitabine versus 18.6 weeks on capecitabine alone in women with advanced or metastatic HER2 (ErbB2) positive breast cancer whose disease had progressed following treatment with trastuzumab and other cancer therapies. The hazard ratio of 0.57 (95% CI: 0.43, 0.77, p = 0.00013) represents a 43 percent reduction in the risk of progression for the patients on the combination arm. Differences between treatment groups based on unblinded investigator assessments were smaller but continued to be clinically and statistically significant.

Adverse events (AEs) leading to discontinuation were similar in the TYKERB-capecitabine combination arm (14 percent) versus capecitabine alone (14 percent). Most commonly reported AEs in the TYKERB-capecitabine combination arm included diarrhea, hand-foot syndrome, nausea, rash, vomiting and fatigue. Left ventricular ejection fraction (LVEF), a measure of the strength of the heart's pumping capacity, was monitored during the study. Among 198 patients who received the TYKERB-capecitabine combination treatment, three experienced an asymptomatic (grade 2) decrease in LVEF and one experienced a symptomatic (grade 3) decrease in LVEF.

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Some generic drugs not nearly as cheap as expected
Policy-makers are looking to generic drugs as one of the most visible ways to cut health care costs. However, the prices of generics may vary greatly and may not be as cheap as expected. Generic versions of Zocor, Zoloft, Zithromax and Flonase have all failed in many cases to provide large sav