Adverse Drug Reaction News and Research

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Quantros acquires MEDMARX from United States Pharmacopeia

U.S. Pharmacopeia (USP) Convention, an official public standards-setting authority for all prescription and over-the-counter medicines sold in the United States, on December 4, 2008 transferred all rights, ownership and management of the overall MEDMARX reporting program to Quantros.

10 Dec 2008

Patient safety compromised with faster drug approvals

With new drugs being reviewed by regulatory agencies and then released onto the market faster than ever before, patients' safety is being compromised, warns a study published on bmj.com.

3 Dec 2008

Warning of serious side-effects of quit-smoking drug Champix

Australian doctors have been warned about the the quit-smoking drug Champix, according to the Therapeutic Goods Administration (TGA) care must be taken when prescribing Champix (varenicline), because of possible serious side-effects.

2 Dec 2008

Nplate receives positive opinion for marketing authorisation in Europe

Amgen has announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nplate (romiplostim) in the European Union (EU).

21 Nov 2008

Fatal flaws in the way new drugs are tested and marketed

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 way new drugs are tested and marketed, according to research to be presented at the annual meeting of the American Sociological Association (ASA).

3 Aug 2008

Heart death risk cut by early warning drugs tests

The likelihood of people dying because their medication has a side effect that affects the electrical activity of the heart is being reduced - thanks to a better understanding of why this happens and the development of tests to predict it.

From The University of Manchester 14 Jul 2008

6 in every 100 patients die in hospital due to adverse drug reaction

Six of every 100 patients who die in hospital do so as a consequence of an adverse drug reaction or, in other words, a fatal reaction to medicines. Those are the conclusions of a research carried out at the Department of Medicine of the University of Granada, in collaboration with the Clinical Hospital San Cecilio of Granada, by Alfredo Jose Pardo Cabello and directed by Professors Emilio Puche Canas (Department of Pharmacology) and Francisco Javier Gomez Jimenez (Department of Medicine).

6 Jul 2008

Controversial diet drug Rimonabant now available on the NHS in Britain

A controversial diet drug has been approved for use on the National Health Service (NHS) in Britain.

24 Jun 2008

Calls for tougher rules on complementary medicines in Australia

Pressure from a consumer group has prompted the Australian Federal Government to consider the introduction of far more stringent disclosure rules regarding complementary medicines.

10 Jun 2008

Marketing of unproven genetic tests a threat to public health

No mechanism currently exists to ensure that genetic tests are supported by adequate evidence before they go to market, or that marketing claims are truthful and not misleading, according to a policy analysis to be published April 4 in Science.

4 Apr 2008

Only two per cent of 700 paediatric drug trials included independent safety checks

Only two per cent of paediatric drug trials reported that they had established independent safety monitoring committees that can help lead to the early detection of adverse drug reactions, according to a major review in the April issue of Acta Paediatrica.

19 Mar 2008

Women are treated less frequently than men with statins, aspirin and beta-blockers

Women and men experience a similar prevalence of adverse drug reactions in the treatment of coronary artery disease; however, women are significantly less likely than their male counterparts to be treated with statins, aspirin, and beta-blockers according to a new study by researchers at Rush University Medical Center.

6 Mar 2008

FDA approves Nexium for gastroesophageal reflux disease in children

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD).

28 Feb 2008

Study finds way to increase use of health information record technologies

Slow diffusion of patient-managed electronic health information record technologies, or PHRs, has limited the development of an interoperable health information infrastructure that will greatly improve health-care quality and cost and will save lives.

4 Jan 2008

Premature ejaculation drug Dapoxetine submitted for marketing in approval in Europe

Janssen-Cilag companies in Europe have submitted a Marketing Authorisation Application (MAA) for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age.

10 Dec 2007

Petition aims to stem the flood of dangerous drugs reaching Americans

In a petition filed with the U.S. Food and Drug Administration, an international coalition of scientists and doctors seeks to compel the agency to stem the flood of dangerous drugs reaching American consumers by mandating the use of scientifically superior non-animal testing methods when those alternatives exist.

15 Nov 2007

London School of Hygiene to play key role in global collaboration on adverse drug reactions

The London School of Hygiene & Tropical Medicine is to be a key player in the first global research collaboration aimed at identifying the genetic markers related to Adverse Drug Reactions (ADRs).

27 Sep 2007

WHO and its partners call for increased research to improve patient safety

They emphasized the need for intensified research at an international conference that opened today in Porto, Portugal. The conference on Patient safety research: shaping the European agenda will examine evidence showing that harm from medical care poses a substantial burden in terms of suffering and death in Europe and around the world.

25 Sep 2007

Hospitals often put allergy sufferers ar risk

Patients are being put at risk because some hospital doctors are not always following warning procedures over known drug allergies, new research launched at the British Pharmaceutical Conference (BPC) in Manchester shows.

10 Sep 2007