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Issue No. 22 | May 25, 2012

News and Features

FDA-Led Research Team Discovers Autoimmune Mechanism for Serious Drug-Induced Adverse Reactions

“A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.

“In an article available online today in the journal AIDS, the team found that in certain at-risk patients, the anti-HIV drug Ziagen (abacavir) causes the immune system to ‘see’ a patient’s own healthy tissues and proteins as a foreign invader. The effect is similar to what happens when the immune system recognizes a viral or bacterial protein during an infection.

“Abacavir is known to cause allergic reactions in certain, at-risk patients. These reactions can range from mild skin reactions to severe allergic shock and even death.

“Abacavir interacts with molecules in the immune system called Human Leukocyte Antigens (HLAs), specifically HLA-B*5701, which help the body to distinguish ‘self’ versus ‘foreign’ proteins. The drug can cause HLA-B*5701 to present for the first time certain ‘self’ proteins that the body has not seen before. Because the body has not previously recognized these ‘self’ proteins, it mistakenly treats them as foreign, resulting in the body trying to destroy its own tissues. HLA-B*5701 is known to be a risk factor for serious reactions to abacavir. ...

“The research team’s work will provide the FDA with new tools to analyze the safety of drugs that have the potential to cause severe allergic reactions. This latest discovery will advance the FDA’s ability to approve therapies that are personalized for safety.”

More information is available:

FDA Approves Generic Formulations of Lamivudine and Zidovudine Tablets and Nevirapine Tablets and Oral Suspension

The FDA recently approved generic formulations for the following antiretroviral agents:

  • Lamivudine and zidovudine tablets, 150 mg/300 mg (see the FDA press release)
  • Nevirapine tablets, 200 mg, and oral suspension, 50 mg/mL (see the FDA press release)

FDA approval of the generic formulations means that they may be marketed in the United States.

A comprehensive list of the approved generic HIV therapeutic drug products is available on the FDA HIV website.