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Recent News and Articles on the Keywords: fda + drugs + drug  Related to the article below (Last Update: 8/4/2008)


Pharmalot
FDA strengthens policy on vetting of advisers
San Francisco Chronicle,  USA -
The Food and Drug Administration said Monday that it will look more closely at conflicts of interest when screening potential members of the influential ...
Drug Advisers With Industry Ties Face Stricter Rules, US Says Bloomberg
FDA advisers must abide by new financial limits The Associated Press
FDA Puts $50000 Cap on Conflicts in Advisory Hearings Wall Street Journal Blogs
The Hill - FDA.gov
all 129 news articles »
Toxic Drugs, Toxic System: Sociologist Predicts Drug Disasters
Science Daily (press release) -
5, 2008) ? Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs such as Vioxx in the future because of fatal flaws in the ...
FDA approves Medicines Co.'s blood-pressure drug
CNNMoney.com -
The Food and Drug Administration approved the injectable drug for patients who cannot take oral medications. Cleviprex is the first non-pill drug to receive ...
UPDATE 1-Medicines Co gets FDA nod for blood pressure drug Reuters
FDA OKs Medicines Co.'s Cleviprex (Update) TheStreet.com
Injected High Blood Pressure Drug Approved by FDA HULIQ (press release)
Chatter Shmatter - Forbes
all 36 news articles »  MDCO

The Money Times
Tomato Growers Seeing Red
Washington Post, United States -
But before the US Food and Drug Administration lifted the tomato advisory July 17, US tomato growers were left holding the shopping bag. ...
Makers of Digitek Recall All Other Drugs US Recall News (press release)
Maker of Defective Digitek Recalls All Generic Drugs Made at New ... Newsinferno.com
Actavis Totowa LLC recalls generic drugs United Press International
TheMedGuru - US Recall News (press release)
all 157 news articles »
Drug Screens Needed for Kids in ER
WebMD -
In 2007, infant cough and cold drugs were withdrawn from the market. The finding, published in this week's journal Pediatrics, highlights the dangers of ...
OTC Cold Medicines Sending Children to Emergency Rooms Washington Post
Report: Cold medicine could be life-threatening for babies USA Today
Study Says Use Of OTC Cold Medications In Infants Still High AHN
FDA news (subscription) - EurekAlert (press release)
all 26 news articles »

ChattahBox
Trials and Medications
RedOrbit, TX -
After the first three phases of study, the FDA will decide to label each proposed new drug a standard review or a priority review. The drugs given priority ...
US Congress slams FDA for off-label promotion control failures Pharma Times (subscription)
Predicting drug disasters Livemint
Anti-Epileptic Drugs and the Risk of Suicide GNIF Brain Blogger
FOXBusiness - ABC News
all 222 news articles »  JNJ - POZN - AMGN
Signs That Diabetes Drug May Extend Lives
New York Times, United States -
Byetta is currently approved for use alongside other diabetes drugs, and Lilly and Amylin have asked the FDA to approve it as a monotherapy as well. ...

dBTechno
With FDA Gaining Power Over Tobacco, They Can Protect Kids
dBTechno, MA -
Washington (dbTechno) - Just last week, the US House of Representatives voted in favor of passing a bill, granting the US Food and Drug Administration (FDA) ...
Editorial: Need to regulate nation's top killer Waco Tribune Herald
The Tobacco Temperance League Human Events
google news commentComment by M. Cass Wheeler Chief Executive Officer,American Heart Association
eFluxMedia - Greenville News
all 557 news articles »

Telegraph.co.uk
Beware Of Sunburn Boosters
CBS News, NY -
Certain drugs and other substances can increase the skin's sensitivity to ultraviolet light and cause the skin to burn in less time or at a lower intensity ...
Connecticut AG: Sunscreen Makers' Claims 'Misleading' Environment News Service
High SPF number not full protection against UV rays News Line 365
Rule would put UVA rating on sunscreen Houston Chronicle
CNNMoney.com - New York Times
all 252 news articles »

Dividend.com
Novartis gets expanded blood-pressure drug OK
Forbes, NY -
AP 08.04.08, 9:08 AM ET Novartis AG said Monday the Food and Drug Administration approved the drugs Diovan HCT and Exforge as initial treatments for high ...
Single-Pill Combinations Diovan HCT and Exforge Approved in US as ... MarketWatch
Novartis reveals blood pressure drug approvals Hays Pharma
FDA approves Novartis' Single-Pill Combinations Diovan HCT and ... RTT News
Dividend.com - Reuters
all 34 news articles »  NVS
Source: Google News

FDA Drug Approval Summary: Gefitinib (ZD1839)(Iressa (R)) Tablets -
MH Cohen, GA Williams, R Sridhara, G Chen, R … - The Oncologist, 2003 - theoncologist.org
... The Oncologist, Vol. 8, No. 4, 303?306, August 2003 ? 2003 AlphaMed Press FDA
COMMENTARY. FDA Drug Approval Summary: Gefitinib (ZD1839) (Iressa ? ) Tablets. ...

Groups, the Media, Agency Waiting Costs, and FDA Drug Approval -
DP Carpenter - American Journal of Political Science, 2002 - JSTOR
... four variables representing the ideology of the median member of the House and Senate,
and the ideology of the median member of the FDA's 453 drugs 298 drugs ...

… Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid … -
FE Silverstein, G Faich, JL Goldstein, LS Simon, T … - JAMA, 2000 - Am Med Assoc
... Celecoxib, a COX-2?specific inhibitor, recently was approved by the US Food and
Drug Administration (FDA) for symptomatic treatment of rheumatoid arthritis ...

FDA evaluations using in vitro metabolism to predict and interpret in vivo metabolic drug-drug -
B Davit - The Journal of Clinical Pharmacology, 1999 - jcp.sagepub.com
... SM Huang and LJ Lesko interactions: impact on labeling FDA evaluations using in
vitro metabolism to predict and interpret in vivo metabolic drug-drug ...

-
M Angell - Jurimetrics, 2004 - HeinOnline
... I suggest ways to do this, including the creation of a separate institute within
the NIH to oversee clinical trials of prescription drugs before FDA approval. ...

[CITATION] Ketamine abuse
FDAD Bulletin - FDA Drug Bulletin, 1979

… Serious gastrointestinal toxicity of nonsteroidal antiinflammatory drugs; drug-containing renal and … -
HE Paulus - Arthritis & Rheumatism, 1988 - csa.com
FDA Arthritis Advisory Committee meeting: Serious gastrointestinal toxicity of
nonsteroidal antiinflammatory drugs; drug-containing renal and biliary stones ...

DrugBank: a comprehensive resource for in silico drug discovery and exploration -
DS Wishart, C Knox, AC Guo, S Shrivastava, M … - Nucleic Acids Research - Oxford Univ Press
... These individual ?Drug Types? are also bundled into two larger categories including
all FDA drugs (Approved Drugs) and All Compounds (Experimental + FDA ...

FDA Drug Approval Summary: Erlotinib (Tarceva (R)) Tablets -
MH Cohen, JR Johnson, YF Chen, R Sridhara, R … - The Oncologist, 2005 - theoncologist.org
... FDA Drug Approval Summary: Erlotinib (Tarceva ? ) Tablets. Martin H. Cohen , John
R. Johnson , Yeh-Fong Chen , Rajeshwari Sridhara , Richard Pazdur ...

FDA Drug Approval Summary: Azacitidine (5-azacytidine, VidazaTM) for Injectable Suspension -
E Kaminskas, AT Farrell, YC Wang, R Sridhara, R … - The Oncologist, 2005 - theoncologist.net
... FDA Drug Approval Summary: Azacitidine (5-azacytidine, Vidaza TM ) for
Injectable Suspension. Edvardas Kaminskas , Ann T. Farrell ...

Source: Google Scholar
 
 

FDA Targets Unapproved Quinine Drugs

U.S. companies that make unapproved prescription drugs that contain quinine have been given 60 days to stop producing the products, the U.S. Food and Drug Administration said Tuesday.

The unapproved drugs are most often prescribed to prevent or treat leg cramps but there are serious safety concerns, including patient deaths, associated with drugs that contain quinine, the FDA said.

Quinine is approved for the treatment of malaria. Because malaria is life-threatening, the risks associated with quinine are justified, the FDA said. There is one FDA-approved quinine drug to treat certain types of malaria without complications. That drug is not affected by the FDA order announced Tuesday.

The label on the approved drug includes warnings about the potential serious side effects of quinine and other important safety information. Quinine drugs can cause cardiac arrhythmias, severe hypersensitivity reactions, and thrombocytopenia, a decrease in blood platelets that can cause hemorrhage or clotting problems.

In addition, there can be serious interactions between quinine drugs and other drugs.

Since 1969, the FDA has received 665 reports of serious adverse events, including 93 deaths, associated with quinine drugs.

Article continues below and (thank you)

 

Moderate Drinking May Lengthen Life

A drink or two a day may help extend your life, suggests an Italian study in the journal Archives of Internal Medicine.

A team at the Research Laboratories of the Catholic University of Campobasso analyzed data on more than a million people and concluded that men who drank up to four small bottles of beer or four small glasses of win a day reduced their risk of dying by almost 20 percent. The same degree of benefit was noted in women who drank two 100 milliliter glasses of wine or two 200 milliliter bottles of beer a day, reported the Daily Express in the U.K. One hundred milliliters is equal to just under 4 ounces.

It was already known that moderate consumption of red wine lowered the risk of heart disease. But this study suggests that moderate drinking reduces the risk of death from all causes.

It's believed that wine, beer and cider may help reduce levels of bad cholesterol and boost levels of good cholesterol. The scientists who conducted this study said that certain compounds found in wine and beer can also help cells repair DNA damage, the Daily Express reported.

"Alcohol contains substances that can protect the body from diseases such as cancer, diabetes and heart disease and this study underlines its beneficial effects," said Professor Giovanni de Gaetano, director of the Research Laboratories. "But the key is not to drink too much as excess immediately increases the risk of an early death."

He noted that other studies have found that spirits don't offer the same protective effects as beer and wine.

-----

Gene Mutation Linked to Family's High Risk for Pancreatic Cancer

U.S. researchers have identified a genetic mutation that may be linked to inherited pancreatic cancer in a Washington state family that's stalked by the disease.

Members of the Chappell family inherit a 50 percent risk of pancreatic cancer. If further research confirms that the genetic mutation is indeed responsible, then the mutation could be used to identify which family members are at risk for the disease, USA Today reported.

Family members without the mutation could have some peace of mind while those with the mutation could be screened in an effort to catch the disease at the early stages, said study senior author Dr. Teri Brentnall of the University of Washington in Seattle.

The study was published online in the journal PLoS Medicine.

While the Chappell family's high risk level may be unique, research into the genetic factors that influence their high rate of pancreatic cancer may help scientists learn more about this and other forms of cancer, USA Today reported.

-----

FDA Approves Drug to Treat Relapsed Lymphoma

The cancer drug Velcade (bortezomib) has been approved by the U.S. Food and Drug Administration for treatment of patients with relapsed mantel cell lymphoma (MCL).

MCL is an aggressive type of non-Hodgkin's lymphoma. The approval offers a new treatment option for these patients. Currently, there are no generally accepted treatment approaches and few options. Velcade is the first drug to receive FDA approval for treatment of patients with relapsed MCL.

A study found that 31 percent of MCL patients who'd received one or two prior therapies responded to Velcade, including eight percent who achieved a complete response that lasted a median of 13. 5 months.

The most common side effects included gastrointestinal problems, fatigue, and numbness and tingling in the hands and feet.

There are about 10,000 MCL patients in the United States. The average life expectancy for patients with relapsed MCL is one to two years. About 20 percent of patients with relapsed MCL survive at least five years.

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FDA Would Widen Patient Access to Experimental Drugs

New rules that would provide easier access to experimental drugs for seriously ill patients who have no other treatment options are being proposed by the U.S. Food and Drug Administration.

The proposed regulatory changes would also clarify the circumstances and costs for which drug makers could charge for an experimental drug.

"FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients," Dr. Janet Woodcock, FDA's deputy commissioner for operations, said in a prepared statement.

"By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for health-care practitioners in obtaining them," Woodcock said.

In order for an experimental drug to be approved for patients, the FDA would have to be satisfied that the potential benefits of the drug outweigh the risks.

The proposed changes, released Monday, are subject to comment for 90 days.

 
 
 
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