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New drug shows promise for those with clotting disorders: McMaster researcher

A new study by McMaster researcher Sam Schulman found that an oral drug called dabigatran etexilate is as safe and effective as warfarin for treating venous thromboembolism (VTE), a common clotting disorder affecting millions annually. The drug does not require frequent monitoring or dose adjustments, making it a convenient alternative.

SourceMcMaster University·JournalNew England Journal of Medicine·DateDec 6, 2009

ICT fails to accelerate drug approvals

A statistical analysis found that FDA review intervals for new drugs remained unchanged from 1997 to 2006, despite increased investment in information technology. The study analyzed data on three main categories of new drugs and found no statistically significant reduction in review times.

SourceInderscience Publishers·JournalInternational Journal of Electronic Healthcare·DateNov 19, 2009

Heartburn drugs deemed safe for fetuses according to Ben-Gurion University researchers

A large cohort study found no significant risks of major congenital malformations associated with H2 blocker exposure during pregnancy. The study involved 1,148 infants exposed to H2 blockers and 84,823 unexposed infants, showing no increased risk of perinatal mortality or birth complications.

SourceAmerican Associates, Ben-Gurion University of the Negev·JournalThe Journal of Clinical Pharmacology·DateOct 7, 2009

New biologic drug is effective against rheumatoid arthritis

Abatacept, a new biologic drug, is effective in treating rheumatoid arthritis by blocking immune cell actions, reducing pain and swelling. The review of seven trials found significant improvements in patients' symptoms and joint health, with no progression of joint damage at 12-month follow-up

SourceWiley·JournalCochrane Database of Systematic Reviews·DateOct 6, 2009

Off-label use: Oft not evidence based

A recent national survey found that physicians inaccurately believed in the FDA approval status of 22 drug-indication pairs, including lorazepam for chronic anxiety and quetiapine for dementia with agitation. The study highlights the need for better methods to inform physicians about the level of evidence supporting off-label drug use.

SourceUniversity of Chicago Medical Center·JournalPharmacoepidemiology and Drug Safety·DateAug 21, 2009

Off-label morning sickness drug deemed safe for fetuses -- Ben-Gurion U. researchers

A large cohort study found that metoclopramide poses no significant risks for fetal development when used to relieve morning sickness nausea, supporting its safe use during pregnancy. The study analyzed data from over 80,000 infants born to mothers who received the medication during the first trimester.

SourceAmerican Associates, Ben-Gurion University of the Negev·JournalNew England Journal of Medicine·DateJun 10, 2009

Extensive publication bias for Phase I drug trials

A recent study found that Phase I drug trials are underreported, with only 17% published in scientific journals. The lack of transparency can compromise the safety and efficacy of new drugs, highlighting the need for increased mechanisms to ensure complete availability of trial results.

SourcePLOS·JournalPLOS Medicine·DateFeb 17, 2009

Meta-analysis examines cardiovascular effects of diabetes medications

A meta-analysis of 40 clinical trials found that metformin hydrochloride was associated with a decreased risk of cardiovascular mortality compared to other oral diabetes agents or placebo. However, the study did not find significant associations between other diabetes medications and beneficial or harmful cardiovascular effects.

SourceJAMA Network·JournalArchives of Internal Medicine·DateOct 27, 2008

Study documents safety problems for biological products

According to a study published in JAMA, approximately one in four approved biological medicinal products had at least one safety-related regulatory action issued 10 years after their approval. The average time to a safety-related regulatory action was 3.7 years, with 70.7% of actions occurring within five years after approval.

SourceJAMA Network·JournalJAMA·DateOct 21, 2008

Tribendimidine shows promise against intestinal worms

A safety and efficacy study found tribendimidine to be effective against hookworm, large roundworm, whipworm, threadworm, and tapeworm infections. The new drug cured up to 92% of soil-transmitted helminth infections in a highly endemic setting in China.

SourcePLOS·JournalPLOS Neglected Tropical Diseases·DateOct 14, 2008

New drug class: Angina

A new drug class, ranolazine, has been approved for the treatment of chronic stable angina, providing a safe and effective alternative to existing treatments. Ranolazine has been shown to reduce anginal episodes by one attack per week and extend exercise time before an angina attack develops, with benefits seen in men more than women.

SourceThe Lancet_DELETED·JournalThe Lancet·DateOct 9, 2008

Free drug samples carry risks for children

A study by Lifespan and Hasbro Children's Hospital found that nearly one in 10 American children received free drug samples in 2004. The top four most frequently distributed medications have significant new safety concerns, including schedule II controlled substances that carry high potential for abuse.

SourceLifespan·JournalPEDIATRICS·DateOct 6, 2008

Common bronchodilator linked to increased deaths

A new study from Northwestern University's Feinberg School of Medicine found that ipratropium increases the risk of heart attack or arrhythmia by 34% compared to albuterol or no treatment. The study suggests that the medication may have a systemic cardiovascular effect, increasing mortality risk in COPD patients.

SourceNorthwestern University·JournalAnnals of Internal Medicine·DateSep 15, 2008

Safety of anti-malarial drugs in pregnancy must be monitored

A new study highlights the need to develop systems to assess antimalarial drug safety in early pregnancy, as artemisinins have been shown to be toxic to embryos in animal models. An international antimalarial pregnancy exposure registry is proposed to enable targeted pharmacovigilance and timely assessment of risk-benefit profiles.

SourcePLOS·JournalPLOS Medicine·DateSep 8, 2008