Generic Drug Approvals

Generic Drug Approvals. First-Time Generic Approvals. Mobic, Propecia, Zithromax

Sexual, Urinary Health Boosted in Exercisers, Nonsmokers


August 28th, 2010 by admin


For people who need more reasons to start exercising and steer clear of smoking, new research finds that moving around and rejecting cigarettes can improve urinary health in women and sexual health in men.

In one study, researchers surveyed more than 2,000 Finnish women, aged 18 to 79, about smoking and their urinary health.

After the investigators adjusted the statistics so they wouldn’t be thrown off by factors such as medication use and lifestyle, the researchers found that former and current smokers were 1.8 to 2.7 times more likely to need to urinate urgently, and 1.7 to 3.0 times more likely to need to urinate more frequently compared to those who never smoked.

In another study, researchers examined surveys taken by 178 healthy men at a VA medical center in North Carolina.

Even after adjusting their statistics for factors such as age and race, the study authors found that those who exercised more often reported better sexual function.

The findings are scheduled to be released Monday at the annual meeting of the American Urological Association in San Francisco.

“We all know that smoking and being sedentary are not good for our health,” Dr. Anthony Y. Smith, an association spokesman, said in a news release. “These data give us one more reason to stop smoking and start exercising.”

SOURCE: American Urological Association, news release.

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Shorter Hospital Stays May Hinder Heart Failure Patients


August 21st, 2010 by admin


Americans hospitalized for heart failure are being discharged faster, but the incidence of out-of-hospital deaths and readmissions has increased, a new study finds.

While in-hospital death rates have decreased, “the results are very mixed, and overall you could say that they are worse off,” said Dr. Harlan M. Krumholz, professor of medicine at Yale University and a member of a team reporting the finding in the June 2 issue of the Journal of the American Medical Association.

In the study of nearly 7 million Medicare-financed hospitalizations for heart failure, the progressive loss of ability to pump blood, the researchers found that the average length of stay decreased by 2.5 days, from 8.8 days in 1993 to 6.3 days in 2006. The in-hospital death rate was nearly halved, dropping from 8.5 percent to 4.3 percent.

But the overall death rate for the 30-day period starting with hospital admission increased, from 4.3 percent in 1993 to 6.4 percent in 2006, meaning that more deaths occurred after discharge. The net reduction in deaths for the 30 days starting with hospital admission was smaller than for the in-hospital rate, from 12.8 percent in 1993 to 10.7 percent in 2006.

And 20.1 percent of those who left the hospital were readmitted in 2006, compared to 17.1 percent in 1993.

“Patients lost ground when they went home,” Krumholz said. “There was no incentive to look at what was happening after discharge. The hospitals kept the patients for the shortest period of time, sent them home and ended up hoping for the best.”

It’s not clear that there is a direct relationship between a shorter hospital stay and more post-hospital deaths and readmissions, said Dr. Adrian F. Hernandez, an assistant professor of medicine at Duke University, who recently led a study showing that hospitals that took pains to prepare heart failure patients for home care had better out-of-hospital results.

“This study highlights that readmission is a common and growing problem,” Hernandez said. “But the demographics of patients admitted with heart failure has changed over time. Patients now tend to be older and sicker.”

Discharges to nursing homes have increased, the new study found, from 13 percent of all discharges in 1996 to 19.9 percent in 2006.

Better hospital discharge practices are needed to improve the out-of-hospital results, Krumholz and Hernandez both said.

“Unless you strengthen the patients with stronger support when they go home, you may run the risk of worsening things,” Krumholz said. “You need to make sure people are ready to go home — make a doctor’s appointment, make sure they take the medications they are prescribed, have a plan of who they should call if they don’t feel well.”

“We should incentivize hospitals or health-care systems to take care of patients for the whole 30 days starting with hospital admission,” Hernandez said. His study found that careful instructions about what should and shouldn’t be done, with a follow-up check, reduced out-of-hospital problems, but it also found that most hospitals didn’t provide such measures.

“From our study, it appears that, on average, you have early follow-up in less than 40 percent of hospitals,” Hernandez said. “There is room for improvement.”

At Yale, “we are interviewing patients and focusing on the transition period,” Krumholz said. “There are new mechanisms that are very successful in navigating this very treacherous period.”

Another report in the same issue of the journal found that people with heart attacks who did not get artery-opening treatment in the 90-minute window recommended in clinical guidelines had a significantly higher risk of death within 30 days or major problems in the following year compared to those whose treatment met the guidelines.

Waiting times for treatment simply are often too long, said study leader Laurie Lambert, principal epidemiologist in the cardiology unit of the Quebec Healthcare Assessment Agency.

“Our study suggests you need to look at the processes of care,” Lambert said. “It is more important that patients be treated on time than which treatment they get.”

SOURCES: Harlan M. Krumholz, M.D., professor, medicine, Yale University, New Haven, Conn.; Adrian F. Hernandez, assistant professor, medicine, Duke University, Durham, N.C.; Laurie Lambert, Ph.D., principal epidemiologist, cardiology unit, Quebec Healthcare Assessment Agency, Montreal.

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Surviving Cardiac Arrest Depends on Your Location


August 14th, 2010 by admin


A person’s chances of surviving a cardiac arrest depend largely on the neighborhood in which they collapse, a new study suggests.

Researchers found that people who suffer from cardiac arrest in some neighborhoods of Fulton County in Georgia — which is home to the city of Atlanta — are up to three times more likely to die than in other neighborhoods. They’re also less likely to have bystanders perform cardiopulmonary resuscitation (CPR) on them.

The neighborhoods with the highest cardiac arrest death rates tended to be poorer and less educated, with more black residents, the study authors noted in their report in the June issue of the Annals of Internal Medicine.

“These findings have national public health indications. They show that it is time to change our thinking on how and where we conduct CPR training if we are ever going to change the dismal rate of survival from cardiac arrest,” study author Dr. Comilla Sasson, who conducted the research at the University of Michigan, said in a news release. “Nine out of 10 people die from a cardiac arrest event.”

The researchers estimated that 15 lives could be saved in Fulton County each year if the neighborhoods with the lowest rates of CPR had the same rates as those neighborhoods with the highest.

“To improve cardiac survival rates that have been stagnant for 30 years, CPR training should be more basic and available to the people who are most likely to witness someone experiencing cardiac arrest,” Sasson said. “Health care resources are extremely limited. To make improvements, we need to understand where and how best to make change.”

SOURCE: Robert Wood Johnson Foundation Clinical Scholars.

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After a point, more omega-3s don’t help the heart


August 7th, 2010 by admin


Memo to adults with heart disease: If you’re already eating a fair amount of fish and taking omega-3 fatty acid supplements, the extra boost may not be doing much to help your heart.

New research suggests that only patients with very low daily intake of certain omega-3 fatty acids, found in fish and some plants and nuts, are likely to reduce their risk of heart attacks or death if they take more supplements rich in these fatty acids.

The study supports research which has shown that, after a certain point, omega-3 supplements may not do much for the heart. It also comes as a new U.S. Government Accountability Office urged more authority for the Food and Drug Administration to inspect the quality and safety of supplements, whose manufacturers often make claims not supported by data.

“Based on data from this and previous studies also in other countries, we think that it is relevant to say that most cardiac patients who are well medically treated and eat at least a certain amount of fish per week, probably will not benefit from taking omega-3 supplements,” Mari Manger, the study’s lead author and a PhD candidate at University of Bergen in Norway, told Reuters Health by e-mail.

The study, published in the American Journal of Clinical Nutrition, followed more than 2,400 Norwegians, about 80 percent of them men, being treated for heart disease. All were on cholesterol-lowering drugs.

At the beginning of the study, all patients filled out a questionnaire about their eating habits, including the fish products and supplements such as cod liver oil that they had eaten over the past year. From this, the authors calculated how much of three different kinds of omega-3 fatty acids thought to be associated with heart health the subjects were getting in their diets and supplements.

The authors then tracked the patients for an average of almost 5 years for heart-related complications, including heart attacks and death. Except for patients who consumed the lowest levels of omega-3s, there was no relationship between how much a person consumed and whether they suffered a heart attack or other complication.

Only two percent of patients in the study consumed levels of two kinds of omega-3s below the recommended level.

Eating more fish and taking more supplements didn’t prevent heart problems, although high levels of omega-3s didn’t hurt the patients either.

These results may be atypical, said Dr. Alice Lichtenstein, a nutritional scientist at Tufts University, because the Norwegian diet differs from that of, say, Americans, who rarely consume fish oil. “This study doesn’t refute current recommendations for individuals to consume more fish,” Lichtenstein, who was not involved with the study, told Reuters Health.

“The current data indicates that there’s probably a threshold” of benefits for omega-3s, “and that’s why the recommendation (from the American Heart Association) is two fish meals a week.”

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Twins Study Points to Environmental Cause for MS


July 30th, 2010 by admin


Genetics can’t seem to explain why one twin would have multiple sclerosis while an identical twin doesn’t, a new study finds.

That leaves scientists still stumped as to what causes multiple sclerosis (MS), although it’s clearer than ever that environmental factors play a major role.

“We found that these twins had a lot of genetic risk factors for MS and yet the twins were born on the same day in the same family, grew up together, ate the same food, went to the same schools and they [both] had that predisposition, that set of risk factors. But, one developed the disease and one didn’t,” said study senior author Dr. Stephen Kingsmore.

“This points to some environmental trigger that protected one of the twins or triggered the disease in one of the twin members,” added Kingsmore, who is CEO of the National Center for Genome Resources in Santa Fe, NM.

According to the researchers, this was the first use of a genome-wide analysis to study an autoimmune disease in identical twins.

The findings are published in the April 29 issue of Nature.

Little is known about the causes of MS, an autoimmune disorder in which the body attacks the myelin sheath that protects the nerve fibers of the central nervous system. It can cause vision problems, muscle weakness, and thinking and memory difficulties.

Genes — not one, but many — clearly play some kind of role, as do as-yet-unidentified environmental factors.

One mystery surrounding the disease has been why 30 to 40 percent of identical twin pairs develop MS, while the rest don’t.

“What makes up the other 60 or 70 percent?” asked Patricia O’Looney, vice president of biomedical research at the National Multiple Sclerosis Society in New York City.

The researchers set out to see if genetic differences accounted for the discrepancy, given that it’s now known that not all identical twins are 100 percent identical.

“A couple of studies in recent years have suggested that identical twins are not identical,” Kingsmore said. “We were kind of betting on the fact that [the twins in this study] wouldn’t be identical.”

Kingsmore and his colleagues looked at three pairs of identical twins in which one twin had MS and the other did not. The oldest twins were in their 50s, the youngest 19.

Three different genetic analyses allowed them to look not only at the genes the twins were born with, but also at gene expression and what’s known as imprinting or epigenetics — when genes change their activity over the course of a lifetime.

“It gives us a very good description of a genome that’s not static,” Kingsmore said. “We weren’t just looking at what you were born with.”

Still, the authors failed to find any genetic explanation for the discrepancy between the twins.

“At the end of the day, we looked under a rock and found no genetic differences in these three pairs of twins,” Kingsmore said. “It was quite a surprise.”

The authors feel they may have ruled out some genetic causes for the disease but, other than that, what triggers MS is still an unanswered question.

The group plans further genetic studies to see if anything was missed the first time around.

“We still don’t have the answers, that’s for sure, but this was only three pairs of twins,” O’Looney pointed out. “Further work needs to take place.”

“It’s a big mystery,” added Kingsmore. “There’s an unknown or undiscovered environmental trigger that’s really important.”

SOURCES: Stephen Kingsmore, M.B, Ch.B, president and chief executive officer, National Center for Genome Resources, Santa Fe, NM; Patricia O’Looney, Ph.D., vice president of biomedical research, National Multiple Sclerosis Society, New York City;

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Acupuncture not helpful for labor pain: report


July 23rd, 2010 by admin


Acupuncture may not help alleviate labor pain, according to a review of past studies trying to establish the efficacy of the treatment.

Researchers from South Korea and Britain examined data from 10 clinical trials involving 2,038 women and found scant evidence that women who had undergone acupuncture experienced less labor pain than those who received no pain relief, a conventional painkiller, a placebo or bogus acupuncture.

“In this review, acupuncture did not seem to have any impact on other maternal or fetal outcomes, nor was it associated with harm,” wrote Hyangsook Lee from the Acupuncture and Meridian Science Research Center at Kyung Hee University in Seoul.

“However, there was no convincing evidence that women receiving acupuncture experience less labor pain than those in the control groups. Acupuncture might reduce the use of other forms of pain relief such as meperidine, but the evidence is limited. To summarize, the current evidence does not appear to recommend the use of acupuncture for labor pain.”

The review was published on Wednesday in the BJOG: An International Journal of Obstetrics and Gynaecology.

Acupuncture has been used as a form of anesthesia in China for at least 2,600 years and experts believe it can clear blockages in circulation.

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FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer


July 16th, 2010 by admin


The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

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FDA Approves Chagas Disease Screening Test for Blood, Tissue and Organ Donors


July 9th, 2010 by admin


The U.S. Food and Drug Administration today approved a second test to screen blood, tissue and organ donors for a blood-borne parasite, Trypanosoma cruzi (T. cruzi) that causes Chagas disease, a serious and potentially fatal parasitic infection.

The test, called Abbott Prism Chagas [Trypanosoma cruzi (E. coli, Recombinant) Antigen], detects antibodies to T. cruzi. It is a fully automated and highly sensitive and specific test for the detection of antibodies to T. cruzi.

The assay is intended as a screen to detect antibodies to T. cruzi in serum or plasma specimens obtained from donors of whole blood and blood components and other living donors.

It is also intended for use to screen organ donors when serum and plasma specimens are obtained while the donor’s heart is still beating and in testing blood specimens to screen cadaveric donors (those whose hearts are not beating).

“Screening for T. cruzi is an important safety measure to help protect our blood supply and help prevent the spread of Chagas disease,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

An estimated 300,000 people in the United States are infected with Chagas disease.

Chagas disease is spread mainly by blood-sucking insects infected with T. cruzi. Chagas disease can also be spread through blood transfusion, organ transplants and from mother to unborn child. National screening of the blood supply was instituted in early 2007, and more than 1,000 donors with T. cruzi infection have been identified within the past three years of testing.

The Abbott Prism Chagas is manufactured by Abbott Laboratories, based in Abbott Park, Ill.

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FDA Issues Warning on Counterfeit Surgical Mesh


June 25th, 2010 by admin


Counterfeit polypropylene mesh products marketed as C. R. Bard/Davol

The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.

The warning is of particular significance to health care professionals and their patients with surgical mesh implants as well as hospitals and surgical centers, operating room medical professionals and staff, and purchasing and risk managers.

Investigations by the FDA and Bard show that the following products, sizes and lots of counterfeit flat sheet polypropylene surgical mesh are not manufactured by Bard. To date, four product sizes have been identified:0112650 – Bard Flat Mesh 2”x 4”
Lot 43APD007 Lot 48HVS036
0112660 – Bard Flat Mesh 10”x 14”
Lot HURL0336 Lot HUSD0629
0112680 – Bard Flat Mesh 3”x 6” Lot 43HPD027
Lot 43HPD032
Lot HUSG0540
Lot 43HDP027
Lot HUSE0532 Lot 43LPD507
Lot HUSF0763
Lot 43IOD011
Lot 43IPD038
0112720 – Bard Flat Mesh 6” x 6” Lot 43FQD327

The FDA is recommending that health care professionals:

Do not use any counterfeit Bard surgical mesh from the lots listed
Carefully examine all manufacturers’ polypropylene surgical mesh products and packaging for lot numbers and anything unusual that might indicate counterfeit mesh
Contact Bard at 800-556-6275 if they think they have one of the counterfeit products
Contact the particular manufacturer if they notice anything unusual or suspicious with any other brand of surgical mesh product or packaging.

The FDA also recommends that health care professionals continue to monitor patients for adverse events as they would any patient with an authentic polypropylene surgical mesh implant, if they suspect or know that counterfeit mesh has been implanted.

Patients should contact their surgeon if they experience problems that they think may be related to surgical mesh.

The FDA continues to gather information and data on the counterfeit mesh to better understand its potential public health impact. The agency also is working to determine who may be responsible and how the counterfeiting and distribution occurred.

At this time, the FDA does not know if the counterfeit surgical mesh meets the authentic product’s specifications, including its strength, sterility, or clinical performance. The FDA assessment of the counterfeit mesh and its potential risk to health is ongoing.

Health care professionals who believe they have received counterfeit or suspect product are asked to contact the FDA’s Office of Criminal Investigations at 800-551-3989 or by visiting the Web site at http://www.fda.gov/OCI.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with this or any counterfeit surgical mesh, the FDA encourages you to file a voluntary report through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) that may be related to the use of these counterfeit products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

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High Natural Estrogen Might Raise Women’s Stroke Risk


June 18th, 2010 by admin


Higher levels of naturally occurring estrogen are tied to a rising risk of stroke in postmenopausal women who aren’t on hormone therapy, a new study finds.

U.S. researchers analyzed medical histories and blood samples from more than 9,700 generally healthy postmenopausal white women recruited for an osteoporosis study in the late 1980s. None of the women were on hormone therapy.

During eight years of follow-up, 247 of the women suffered a first stroke. Those women were compared with 243 women who did not have a stroke.

The researchers found that women with the highest levels of estradiol (the most potent naturally occurring estrogen) were 2.3 times more likely to suffer a stroke than those with the lowest levels.

“These results raise the possibility that estradiol levels might be a decision-making tool for health care providers and their female patients when discussing stroke and weighing the option of estrogen therapy,” study leader Jennifer Lee, an endocrinologist and epidemiologist at the University of California, Davis Health System, said in a news release.

The researchers also found that women with waist sizes larger than 34 inches had higher estradiol levels and greater stroke risk than those with smaller waist sizes.

“In women with waist girths greater than 34 inches, high estradiol levels conferred a six-fold greater stroke risk over low levels,” Lee said. “This might be because fat around the midsection is a source of naturally occurring estrogen. Reducing waist size would be a good defense against future stroke.”

The study appears in a recent issue of the Archives of Neurology.

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