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Pharmaceutical industry
Europe: Medicines under additional monitoring

The European Medicines Agency has published today the initial list of medicines under additional monitoring. These medicines are being monitored even more intensively than other medicines. This is generally because there is less information available on it than on other medicines, for example because it is new to the market or there is limited data on its long-term use. It does not mean that the medicine is unsafe.

Published
26 April 2013
From
European Medicines Agency
Cardiovascular disease
Genetics make a large contribution to cardiovascular risk for people with HIV

Genetic background has a major impact on the risk of coronary artery disease for people with HIV, results of a large study published in the online edition

Published
24 April 2013
By
Michael Carter
Side-effects
Scientists explore mystery of a psychedelic HIV/AIDS drug

For those taking antiretroviral medications for HIV/AIDS, there is one drug in the mix that can put a particular kick in the cocktail: the drug efavirenz, marketed under the commercial names Sustiva and Stocrin, appears to have an "LSD-like interaction" with the receptors in the brain that govern the activity of serotonin, says a study presented in Boston today.

Published
23 April 2013
From
Los Angeles Times
Side-effects
Almost three-quarters of people starting HIV therapy in Tanzania have dyslipidemia after three years of treatment

Approximately 75% of HIV-positive patients in Tanzania had lipid abnormalities three years after starting antiretroviral therapy, research published in the online edition of Clinical Infectious Diseases shows.

Published
28 March 2013
By
Michael Carter
Side-effects
EU new drug approval studies "have too few patients to evaluate safety"

For medicines intended for chronic use, the number of patients studied before regulatory approval in the European Union (EU) is insufficient to properly evaluate safety and long-term efficacy, and this points to a need for new EU legislation, say researchers writing in this week's PLOS Medicine.

Published
22 March 2013
From
Pharma Times
Side-effects
Long-term efavirenz linked to worse neurocognitive function in US CHARTER group

Long-term treatment with an efavirenz-based regimen correlated with worse neurocognitive function than did treatment with lopinavir/ritonavir, according to results of a retrospective case-control comparison within the US CHARTER cohort.

Published
07 March 2013
From
EATG / NATAP
New and experimental HIV treatments
Dual CCR5/CCR2 inhibitor cenicriviroc has anti-inflammatory as well as anti-HIV effect

Cenicriviroc, which blocks both CCR5 and CCR2 receptors on immune cells, is effective against HIV, better tolerated than current antiretrovirals and has immunomodulatory activity that may reduce inflammation,

Published
06 March 2013
By
Liz Highleyman
Prevention of mother-to-child transmission
Small risk of neurological birth defects due to efavirenz confirmed in French cohort

A large French study has found an elevated risk of some birth defects in children born to women exposed to some antiretroviral drugs during the first trimester

Published
06 March 2013
By
Keith Alcorn
Side-effects
Intelence (etravirine) labeling updates

On February 27, 2013, FDA approved changes to the Intelence (etravirine) label to include revisions to the Warnings and Precautions, Adverse Reactions, and Postmarketing Experience sections to include information regarding drug rash with eosinophilia and systemic symptoms (DRESS), to update Adverse Reaction section with information regarding the occurrence of rash in men vs. women and pediatric patients and to add drug interaction information for artemether/lumefantrine and telaprevir

Published
02 March 2013
From
US Food and Drug Administration
Kidney problems
Tenofovir, atazanavir/ritonavir and Kaletra associated with kidney problems in patients taking HIV therapy

Data from a large study into the safety of anti-HIV drugs suggest that the antiretrovirals tenofovir (Viread, also in Truvada, Atripla and Eviplera), atazanavir (Reyataz) and lopinavir/ritonavir

Published
15 February 2013
By
Michael Carter
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