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European Medicines Agency Drops Class-wide Nucleoside/Nucleotide Drug Warning

The European Medicines Agency recently updated its advice about lipodystrophy and lactic acidosis for people being treated for HIV, and called for modification of the warning required on all nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), as these toxicities are now known to be associated with specific drugs that are no longer widely used in high-income countries. U.S. advocates have asked the Food and Drug Administration (FDA) to make a similar change.

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Atripla Label Adds Drug Interactions with Hepatitis C Protease Inhibitors Boceprevir and Telaprevir

The U.S. Food and Drug Administration (FDA) announced this week that the product label information for Atripla -- the HIV single-tablet regimen containing efavirenz/tenofovir/emtricitabine -- has been updated to include information about drug-drug interactions with the hepatitis C virus protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek or Incivo).

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Kaletra Label Updated to Add Drug Interactions, Including Boceprevir and Telaprevir

Product label information for the HIV protease inhibitor lopinavir/ritonavir (Kaletra) was revised to include information about several additional medications with the potential for drug-drug interactions, the U.S. Food and Drug Administration (FDA) announced last week.

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Atazanavir (Reyataz) Label Update Adds Kidney Warning, Drug Interactions

Product label information for the HIV protease inhibitor atazanavir (brand name Reyataz) was recently revised to include new warnings about cholelithiasis or gall bladder stones and interstitial nephritis (a type of kidney inflammation), as well as interactions with several other medications, including the hepatitis C virus protease inhibitor boceprevir (Victrelis).

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Statin Interactions with HIV or Hepatitis C Drugs Can Cause Muscle and Kidney Damage, FDA Warns

Statins, a class of drugs prescribed to lower cholesterol and reduce the risk of cardiovascular disease, can interact with certain medications used to treat HIV and hepatitis C virus (HCV) potentially leading to serious side effects, the U.S. Food and Drug Administration (FDA) warned yesterday.alt

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Complera Label Adds Low Viral Load Restriction, Liver Toxicity Warning

The U.S. Food and Drug Administration (FDA) last week approved revised label information for Complera, Gilead Sciences' tenofovir/emtricitabine/rilpivirine single-tablet regimen. Among the changes, the updated label clarifies that this regimen is indicated for previously untreated people with low baseline viral load, as those with higher levels were more likely to experience treatment failure in clinical trials.

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Raltegravir (Isentress) Label Updated with New Side Effects Warning

The U.S. Food and Drug Administration (FDA) this week announced that the product information for the integrase inhibitor raltegravir (brand name Isentress) has been revised to include new warnings about potential skin reactions and other adverse events.alt

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