Adverse Drug Reaction News and Research

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Psychotropic medications associated with adverse drug reactions in Danish children: Researchers

Between 1998 and 2007, psychotropic medications were associated with 429 adverse drug reactions in Danish children under the age of 17. Researchers from the University of Copenhagen's Faculty of Pharmaceutical Studies have published an article in the open access journal BMC Research Notes concluding that more than half of the 429 cases were serious and several involved birth defects, such as birth deformities and severe withdrawal syndromes.

25 Jun 2010

Psychotropic medications associated with pediatric ADRs in Denmark: Researchers

Between 1998 and 2007, psychotropic medications were associated with 429 adverse drug reactions in children under 17 in Denmark. Researchers writing in the open access journal BMC Research Notes found that more than half of these were serious and several were birth defects - suggesting that tighter controls on the prescription of psychotropic medications to pregnant women may be required.

23 Jun 2010

UMC introduces new software certification program for WHO Drug Dictionary Enhanced

Uppsala Monitoring Centre, a Collaborating Centre to the World Health Organisation and the global intelligence network for benefits and risk in medicinal products, today officially launches a software certification program that helps software developers integrate the WHO Drug Dictionary Enhanced quickly and easily.

14 Jun 2010

Phase Forward Central Coding application achieves UMC's new certification

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, today announced its Central Coding™ application has become the first product to achieve certification by the Uppsala Monitoring Center (UMC). Launched today ("Uppsala Monitoring Centre Launches Software Certification Program for WHO Drug Dictionary Enhanced"), UMC's new certification is designed to help software developers quickly and easily integrate the WHO Drug Dictionary Enhanced.

14 Jun 2010

Experts discuss recent advancements in personalized medicine for treating childhood disorders

Many of the world's leading experts in pediatric pharmacogenomics and personalized medicine are gathering today at a first-of-its-kind conference in Kansas City to change the way childhood diseases and illnesses are treated.

29 Apr 2010

Seasonal flu shots: Are they responsible for the adverse reactions? Investigations on

After the seasonal flu vaccines caused over 250 cases of fever, vomiting and convulsions and one reported death in under-fives there has been intense investigations to detect the cause. Further vaccinations were stopped last Friday.

28 Apr 2010

First-of-its-kind conference on personalized medicine for pediatric patients

The world's leading experts in pediatric pharmacogenomics and personalized medicine are gathering at a first-of-its-kind conference in Kansas City to change the way childhood diseases and illnesses are treated through personalized medicine.

22 Apr 2010

Amgen announces results from first Phase 1/2 study of Nplate

Amgen Inc. today announced results from its first Phase 1/2 study evaluating the safety and efficacy of Nplate® (romiplostim) in children with chronic immune thrombocytopenic purpura (ITP).

8 Dec 2009

Amgen announces results from three studies on the safety and efficacy of Nplate

Amgen Inc. today announced results from three studies on the safety and efficacy of Nplate® (romiplostim) in adult patients with myelodysplastic syndromes (MDS).

7 Dec 2009

Amgen to present updated data on Nplate at the 2009 ASH meeting

Amgen Inc. today announced that it will present updated long-term safety and efficacy data for Nplate® (romiplostim) in adult chronic immune (idiopathic) thrombocytopenic purpura (ITP). Additionally, Amgen will present the first Nplate study in a pediatric setting as well as in patients with myelodysplastic syndromes (MDS) at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition (Dec. 5 - 8, 2009).

1 Dec 2009

Reorganizing the FDA could save Americans trillions of dollars over the next decade, says legal expert

While Congress and the rest of the nation turn the battle over healthcare reform into a pro-wrestling-style steel cage death match with enough rhetoric to choke an English professor, at least one expert is looking beyond the bills on the table for a different solution.

17 Nov 2009

Women more likely to suffer from adverse drug reactions than men; proactive approach may help reduce problems

Most people have taken a prescription medication at one time or another, but according to a report from the Agency of Healthcare Research and Quality (AHRQ) in Rockville, Md., not only do women take more medications during their lifetimes, women are more likely to suffer from adverse drug events than men.

30 Oct 2009

Safety tips for OTC and prescription medications

The beginning of October marks the start of Talk About Prescriptions Month, which is sponsored by the National Council on Patient Information and Education. In support of this annual awareness effort, Health Net, Inc. (NYSE:HNT) is sharing tips to help consumers safely take over-the-counter (OTC) and prescription medications.

23 Sep 2009

Study reveals high level of adverse drug reactions in hospitals

In a study of more than 3,000 patients, researchers at the University of Liverpool have found that one in seven admitted to hospital experience adverse drug reactions to medical treatment.

15 Feb 2009

Schering-Plough announces European submission of fertility medicine Corifollitropin Alfa

Schering-Plough Corp. has announced that the European Medicines Agency (EMEA) has validated (accepted for review) its Marketing Authorization Application (MAA) for corifollitropin alfa, the company's experimental, sustained follicle stimulant (SFS).

1 Jan 2009

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