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Topic: Drug safety

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	Center for Drug Safety Offers E-Prescribing, CPOE, After Hours Review, Drug Interaction and Patient Safety
		The Center for Drug Safety is a medical ASP (Application Service Provider) designed to bring valuable and even life saving data to patients, doctors, clinics, pharmacies, and hospitals to ensure that medications are taken properly, safely and in a manner insuring the best possible results from the treatment.
		Adverse drug reactions are unintended and or unexpected responses to drug regimens that cause or prolong hospitalization.
		Drug interaction is how one or more drugs interact with each other, food and patient specific conditions such as height, weight, age, gender, race, and existing disease states.
	www.centerfordrugsafety.org (1287 words)

	FDAReview.org, a project of The Independent Institute: FDA Glossary
		Drug loss is difficult to measure, although Peltzman’s (1973) results (see also the discussion in the text) suggest that it is very extensive.
		Under the Food, Drug, and Cosmetic Act of 1938, the NDA was submitted to the FDA enumerating the uses of the drug and providing evidence of its safety.
		Drugs to reduce cholesterol, for example, are intended ultimately to reduce the number of heart attacks and thus to lengthen life expectancy.
	www.fdareview.org /glossary.shtml (7941 words)

	Uppsala Monitoring Centre - Definitions (Site not responding. Last check: 2007-10-14)
		Monitoring, evaluating and communicating drug safety is a public-health activity with profound implications that depend on the integrity and collective responsibility of all parties - consumers, health professionals, researchers, academia, media, pharmaceutical industry, drug regulators, governments and international organisations - working together.
		Flaws in drug safety communication at all levels of society can lead to mistrust, misinformation and misguided actions resulting in harm and the creation of a climate where drug safety data may be hidden, withheld, or ignored.
		Drug information directed to the public in whatever form should be balanced with respect to risks and benefits.
	www.who-umc.org /defs.html (2227 words)

	The Epoch Times \| Most FDA Staff Had Drug Safety Concerns-Survey
		Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday.
		The drug was pulled from the market Sept. 30 over links to heart attacks and strokes.
		Graham, associate director for science in the FDA's Office of Drug Safety, also told Congress he felt the FDA was incapable of protecting the public from other dangerous drugs.
	english.epochtimes.com /news/4-12-23/25122.html (331 words)

	Herbal safety news (Site not responding. Last check: 2007-10-14)
		This section is dedicated to safety issues associated with herbal medicines and will be regularly updated to ensure that the most relevant information is available to as wide an audience as possible.
		It provides useful safety information for anyone using herbal medicines and anyone operating in the herbal medicines sector, including manufacturers, herbal practitioners, suppliers and retailers.
		Information and advice on safety issues is regularly given to health professionals, the public and interest groups in a range of different ways, including this newsletter.
	www.mca.gov.uk /ourwork/licensingmeds/herbalmeds/herbalsafety.htm (5482 words)

	Pharma Watch (Site not responding. Last check: 2007-10-14)
		Japan was quick to adopt the anti-cancer drug Iressa, in no small part because Astrazeneca were advertising it even before it was approved.
		The stakes for the drug companies are especially high in disease areas like hypertension, where the potential markets are huge (about 60 million Americans have high blood pressure) and where doctors can prescribe among a variety of competing brand-name drugs with similar characteristics.
		It is believed to be the first company to make such a promise but many drug makers have been changing the tenor of their advertising in response to rising complaints from doctors, patients and lawmakers about the amount and accuracy of the advertising.
	www.pharmawatch.blogspot.com (3162 words)

	FDAReview.org, a project of The Independent Institute
		Medical drugs and devices cannot be marketed in the United States unless the U.
		We argue that FDA control over drugs and devices has large and often overlooked costs that almost certainly exceed the benefits.
		We believe that FDA regulation of the medical industry has suppressed and delayed new drugs and devices, and has increased costs, with a net result of more morbidity and mortality.
	www.fdareview.org (175 words)

	Hospital Pharmacist \| EAHP meeting: Strategies for safety
		Developing practical strategies to promote drug and medication safety was the key theme of the 8th congress of the European Association of Hospital Pharmacists held in Florence from 26 to 28 February.
		Extrapolation of data from the most comprehensive adverse drug event (ADE) prevention study to a large NHS hospital trust suggested that a total of 5853 ADEs could be expected annually, of which 697 would be life threatening and 58 fatal.
		In future, it should be possible to improve treatment for children by linking knowledge of the patterns of age and disease in drug disposition with knowledge of the genotype for drug metabolising enzyme transporters and receptors, knowledge of the genetics of disease expression and the flexibility to tailor drug treatment, said Professor Kearns.
	www.pharmj.com /Hospital/Editorial/200305/articles/eahp.html (2742 words)

	Cholesterol Drug Safety Questioned
		Crestor is one of the most powerful cholesterol-lowering drugs on the market.
		But by March 2004, seven cases of a muscle-destroying condition and nine cases of kidney failure led the consumer group Public Citizen to petition the FDA to withdraw its approval.
		The drug is a 'must' drug for them and they are stooping to anything they can do to keep it on the market, including an extraordinarily misleading letter to British doctors."
	my.webmd.com /content/article/87/99460.htm (606 words)

	Blacktriangle.org Homepage of Anthony Cox (Site not responding. Last check: 2007-10-14)
		Just as an aside, there is nothing to stop patients reporting adverse drug reactions to the MHRA via their local pharmacist who is well-trained and highly accessible in the community to discuss management of adverse drug reactions face-to-face with the patient.
		One of these drugs, troglitazone, was associated with a risk of liver failure, which had been played down by the manufacturing company.
		Drug Interactions: JAMA has an interesting article on drug interactions: "During the 7-year study period, 909 elderly patients receiving glyburide were admitted with a diagnosis of hypoglycemia.
	www.blacktriangle.org /blogarchive/2003_04_01_archive.html (3199 words)

	Hawaii State Department of Health - www.hawaii.gov/health
		The Food and Drug Branch administers the statewide Food and Drug program, a regulatory program that is mandated by law and with a large and diverse area of responsibility.
		It safeguards public health by ensuring that food, drugs, cosmetics, medical devices and related consumer products are safe, effective and properly labeled.
		The drugs that are regulated by the branch include over-the counter, prescription, and generic drugs.
	www.hawaii.gov /health/environmental/food_drug/index.html (147 words)

	FDA Plans New Board To Monitor Drug Safety (washingtonpost.com)
		The Food and Drug Administration will create an independent board to more aggressively monitor the safety of drugs on the market as part of an effort to restore public confidence in the nation's prescription drug supply, Health and Human Services Secretary Mike Leavitt announced yesterday.
		The Drug Safety Oversight Board would, for the first time, take the officials who approve new drugs largely out of the process of assessing whether side effects that appear later are serious enough to require quick regulatory action.
		The FDA expert panel could recommend that all COX-2 drugs be withdrawn from the market or carry a stern "fl box" warning of the risks, or it could vote to recommend no change in current regulations.
	www.washingtonpost.com /wp-dyn/articles/A25893-2005Feb15.html (587 words)

	Failures of the therapeutic chain as a cause of drug ineffectiveness -- Figueras and Laporte 326 (7395): 895 -- BMJ
		Failures of the therapeutic chain as a cause of drug ineffectiveness -- Figueras and Laporte 326 (7395): 895 -- BMJ
		Failure of drug treatment may be due to wrong diagnosis, selection of an inappropriate drug or dosage, use of an adulterated
		Incidence of adverse drug reactions in hospitalized patients.
	bmj.com /cgi/content/full/326/7395/895 (1181 words)

	FDA Bars Critic From Meeting (washingtonpost.com)
		A prominent drug safety expert has been removed from a Food and Drug Administration advisory panel meeting on Vioxx and other arthritis drugs because of comments he made this week suggesting that the entire class of medications may be unsafe.
		The drug is a COX-2 inhibitor such as Vioxx, which Merck and Co. took off the market in September because of a study showing that it increased the risk of heart attacks and strokes.
		Sandra Kweder, deputy director of the FDA Office of New Drugs, said it was not unusual for advisory panel members to be kept from participating in a meeting if they have clear financial interests or intellectual positions that could keep them from being objective.
	www.washingtonpost.com /wp-dyn/articles/A46656-2004Nov12.html (551 words)

	West Midlands Centre for Adverse Drug Reporting
		The Australian Adverse Drug Reaction Advisory Committee have just published their latest bulletin featuring ADRs to complementary medicines, advoiding isotretinoin in pregnancy, bisphosphonates and osteonecrosis of the jaw, and statins now contraindicated in pregnancy.
		The move is part of a series of measures to further improve the drug side effect reporting system - theYellow Card Scheme, which is used by the medicines watchdog (MHRA) to monitor the safety of medicines in the UK.
		Forms to report unexpected drug reactions will available in 4000 GP surgeries across the UK and patients will also be able to make reports online.
	www.csmwm.org /safety_issues.htm (616 words)

	bmj.com Rapid Responses for Dunn, 326 (7397) 1018
		There is increasing concern about patient safety and medication use is a significant contributory cause of threats to patient safety [1][2].
		Patient safety will not improve unless we learn from these events - the same problem will return to haunt both the patient and the doctor in the future, may be with more serious consequences.
		It is supposed to mean an event that might be due to a drug but is not necessarily due to it, but the addition of the word "drug" to the term "adverse event" adds nothing helpful, and the whole term implies to the casual reader that an adverse drug event is an adverse drug reaction.
	bmj.com /cgi/eletters/326/7397/1018 (1037 words)

	[No title] (Site not responding. Last check: 2007-10-14)
		Some drugs should not be taken in conjunction with each other because they have conflicting effects, and some drugs shouldn't be taken in combination because they have the same effects.
		All three of these drugs are tranquilizers, and if you stack them one on top of another, their combined effect will leave you dopey and helpless.
		The culprits were mostly "Docs-in- a-box" who prescribed for patients with whom they had no long-term relationship, and specialists who prescribed for conditions within their specialty without adequately checking on their patients' other meds.
	www.wnydf.bfn.org /library/polyphar.text (471 words)

	Blacktriangle.org Homepage of Anthony Cox
		Drug Driving: "Over-the-counter medicines have inconsistent and inaccurate labels that pose a danger to drivers, the Department of Transport says.
		These are the trappings of doctors and drug companies being entwined in an embrace of avarice and excess, an embrace that distorts medical information and patient care.
		WHOs Viewpoint: "For the first time in a widely distributed publication, the issues and questions surrounding the safety of drugs will be discussed in a simple and accessible way for the general and specialist reader.
	www.blacktriangle.org /blogarchive/2003_05_01_archive.html (2487 words)

	HHS - Drug & Food
		Drugs by Drug Name (Food and Drug Administration)
		Generic Drugs: Consumer Q and A (Food and Drug Administration)
		Food Safety for Seniors (Food and Drug Administration)
	www.hhs.gov /drugs/index.shtml (832 words)

	National Patient Safety Agency
		The National Patient Safety Agency is currently implementing a national campaign to reduce infections in NHS hospitals.
		The system is designed to draw together reports of patient safety errors and systems failures from health professionals across England and Wales to help the NHS to learn from things that go wrong.
		Improving the safety of patients with established spinal injuries in hospital 15 Sep 2004
	www.npsa.nhs.uk (1299 words)

	BCDSP Drug Safety & Pharmacoepidemiology Symposium
		The history of the annual BCDSP symposium goes back to the early 1980s, a time when few people were publishing research papers in the field of drug safety epidemiology.
		The meeting is attended by international leaders in drug safety and pharmacoepidemiology from academia, pharmaceutical industry and regulatory authorities.
		It is this extraordinary combination of people with different perspectives on the field of drug safety who come together at this exceptional location that gives the workshop its unique and highly interactive character.
	www.bcdsp.org /symposium.html (240 words)

	2002.04.19:HHS Launches New Pediatric Drug Safety Initiative
		HHS Secretary Tommy G. Thompson today launched a new initiative to further ensure the safety and effectiveness of drugs used to treat children and promised to continue to enforce the Food and Drug Administration (FDA) rule requiring companies to take steps to ensure drugs are properly labeled for pediatric use based on scientific studies.
		The law's provisions include new funding mechanisms for pediatric studies that companies choose not to conduct and other provisions that encourage the development of better information on the effective use of drugs in children.
		The new law also permits the NIH Foundation to fund pediatric studies of certain drugs with private donations received for that purpose, providing an additional funding source.
	www.hhs.gov /news/press/2002pres/20020419b.html (538 words)

	- Drug safety during breastfeeding
		Although many medications are safe to use while breastfeeding, almost any drug will get into your milk to some degree and can occasionally affect your milk supply.
		If you have more questions about how a drug you are taking may affect your breast milk or your baby, call the UCSD information service at (900) 226-7536, 9 a.m.
		Little is known about the effects these drugs may have on a breastfeeding infant, but if there is an effect, it will probably be mild.
	www.babycenter.com /general/baby/babybreastfeed/8790.html (694 words)

	Biotechnology Information Directory - Products and Services - Clinical Trials
		Clinical trials are the basis for determining the safety and efficacy of pharmaceuticals, biologics and medical devices.
		BASi A drug development firm providing contract research services and products for the pharmaceutical, biotechnology and medical device industries; manufacturer of specialized instrumentation and accessories for liquid chromatography, in vivo sampling (whole blood, plasma, microdialysis and ultrafiltration), veterinary medicine and electrochemistry; provides contract research services under FDA GLP and cGMP quality assurance systems.
		West Pharmaceutical Services Drug delivery development, design and manufacture of medical devices and packaging systems, laboratory testing services, and contract manufacturing and packaging.
	www.cato.com /biotech/bio-prod-cro.html (5861 words)

	The Kansas Department of Health and Environment
		The FPCS program goals are directed by the Secretary's Food Safety Initiative and are accomplished through standardized sanitation and food safety inspections of over 11,500 regulated facilities.
		Staff are certified by the U.S. Food and Drug Administration and the U.S. Consumer Product Safety Commission to carry out work under contract for these federal agencies.
		Response to consumer complaints, inspections and special investigations help assure compliance with state and federal food, drug and consumer safety regulations.
	www.kdhe.state.ks.us /fpcs/index.html (169 words)

	MedlinePlus: Drug Safety
		Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update (Food and Drug Administration)
		Drug Name Confusion: Preventing Medication Errors (Food and Drug Administration)
		Drug Research and Children (Food and Drug Administration)
	www.nlm.nih.gov /medlineplus/drugandmedicaldevicesafety.html (516 words)

	Public Health Advisory and Recall of Products Containing Phenylpropanolamine (PPA) (Site not responding. Last check: 2007-10-14)
		This drug is widely used as a nasal decongestant and for weight control.
		PPA has been marketed for many years and a very small number of people taking the drug have had strokes, but a recent study by scientists at Yale University reported that taking PPA increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women.
		The increased risk of hemorrhagic stroke was detected among women using the drug for weight control and for nasal decongestion in the 3 days after starting use of the medication, but men may also be at risk.
	healthlink.mcw.edu /article/973892533.html (631 words)

	Thomas J. Moore's Web Site (Site not responding. Last check: 2007-10-14)
		This is our new drug safety site focusing on scientific issues.
		The modern commerical aircraft is among the most effective instruments known for the spread of flu and other respiratory infections.
		My latest book exposes the flawed system that is supposed to protect people from serious injury and death caused by drug adverse reactions.
	www.thomasjmoore.com (126 words)

	Formulary - Home Page
		Cyclooxygenase-2 (COX-2)-selective nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely prescribed for patients with arthritis and other conditions because of their lower risk for gastrointestinal adverse events compared with nonselective NSAIDs 1,2
		The objective of this study was to track the utilization of anti-inflammatory drugs among patients with active rofecoxib prescriptions at the time of market withdrawal through retrospective analysis of pharmacy records and to assess the need for COX-2 inhibitor therapy due to gastrointestinal risk factors.
		Drug Watch, a head-up on pharmaceuticals in late-state development for HIV-AIDS
	www.formularyjournal.com (388 words)

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