Aptivus (tipranavir) is in a class of antiviral medication called protease inhibitors. This group of HIV medicines works by preventing HIV cells from multiplying in the body. Aptivus was approved by the FDA in 2005, and approved for pediatric use in 2008. Although Aptivus has been proved effective, it is theorized that its side effects may be more dangerous than alternative antiretrovirals.
Aptivus is manufactured by Boehringer Ingelheim and received a black box warning for the possibility of severe liver problems—especially in people who already had liver disease. It received another black box warning in 2006 warning of brain bleeding in patients taking the drug. Boehringer Ingelheim stated that it had knowledge of four cases of brain bleeding during clinical trials, and sent letters to physicians informing them about the case. Many of the patients who presented the side effect also had other conditions such as; lesions in the central nervous system, head trauma, recent brain surgery, and problems with blood clotting, high blood pressure and alcohol abuse.
Along with reports of hemorrhaging in the brain, Aptivus was linked to diabetes mellitus, hepatitis and increase in cholesterol.
Side effects may include:
- Unusual bleeding (such as a nosebleed or blood in your urine or stools)
- Problems with walking, breathing, speech, swallowing, or eye movement
- Sudden severe headache, confusion, severe drowsiness
- Sudden numbness or weakness on one side of the body
- Upper stomach pain
- Loss of appetite
- Dark urine
- Clay-colored stools
- Jaundice (yellowing of the skin or eyes)
- Mild nausea, vomiting, stomach pain
- Mild headache or
- Changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist)
Serious side effects may include:
- Severe skin rash, blistering, peeling, or sunburn
- Increased urination or extreme thirst
- Rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems
- Diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
- Swelling in your neck or throat (enlarged thyroid)
- Muscle weakness, tired feeling, joint or muscle pain, weakness or prickly feeling in your fingers or
- Severe lower back pain, loss of bladder or bowel control; or
- Signs of a new infection, such as fever or chills, cough, skin lesions, or flu symptoms.