Zerit (Stavudine)

• Lactic acidosis, severe increase of lactic acid in the blood, severe liver enlargement, including inflammation (pain and swelling) of the liver, and liver failure, which can cause death.

• Peripheral neuropathy, a nerve disorder of the hands and feet.

People who take ZERIT along with other medicines that may cause similar side effects may have a higher chance of developing these side effects than if they took ZERIT alone. For example, if you use ZERIT in combination with other drugs (including didanosine) that may be associated with liver enlargement, peripheral neuropathy, or pancreatitis, you may be at increased risk for these side effects. Children experience side effects that are similar to those experienced by adults.

Lactic acidosis and severe liver enlargement—Lactic acidosis and severe liver enlargement, including deaths, have been reported among patients taking ZERIT. Symptoms of lactic acidosis may include:

• nausea, vomiting, or unusual or unexpected stomach discomfort;

• feeling very weak and tired;

• shortness of breath;

• weakness in arms and legs.

If you notice these symptoms or if your medical condition has suddenly changed, stop taking ZERIT and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital. Women, overweight patients, and those who have had lengthy treatment with nucleoside medicines are more likely to develop lactic acidosis. Your doctor should check your liver function periodically while you are taking ZERIT, especially if you have a history of heavy alcohol use or a liver problem. The combination of ZERIT and didanosine may increase your risk for liver damage, which may be fatal. Your doctor should closely monitor your liver function if you are taking this combination.

Fat redistribution—Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

Peripheral neuropathy—This nerve disorder is rare, but may be serious. Tell your doctor right away if you or a child taking ZERIT has continuing numbness, tingling, burning, or pain in the feet and/or hands. A child may not recognize these symptoms or know to tell you that his or her feet or hands are numb, burning, tingling, or painful. Ask your child's doctor for instructions on how to find out if your child develops peripheral neuropathy.

Let your doctor know if you or a child taking ZERIT has ever had peripheral neuropathy, because this condition occurs more often in patients who have had it previously. Peripheral neuropathy is also more likely to occur in patients taking drugs that affect the nerves and in patients with advanced HIV disease, but it can occur at any disease stage. If you develop peripheral neuropathy, your doctor may tell you to stop taking ZERIT. In some cases the symptoms worsen for a short time before getting better. Once symptoms of peripheral neuropathy go away completely, your doctor may decide to start ZERIT again at a lower dose.

Pancreatitis—Pancreatitis is a dangerous inflammation of the pancreas. It may cause death. Tell your doctor right away if you develop stomach pain, nausea, or vomiting. These can be signs of pancreatitis. Let your doctor know if you have ever had pancreatitis, regularly drink alcoholic beverages, or have gallstones. Pancreatitis occurs more often in patients with these conditions. It is also more likely in people with advanced HIV disease, but can occur at any disease stage. The combination of ZERIT and didanosine, with or without hydroxyurea, may increase your risk for pancreatitis.

Immune reconstitution syndrome—Your immune system may get stronger when you start taking HIV medecines. It may begin to fight infections that have been hidden in your body for a long time or your immune system could react against your own body (autoimmune disease). Examples are Graves' disease (which affects your thyroid gland), Guillain-Barré Syndrome (which affects the nervous system) or polymyositis (which affects the muscles). Autoimmune disease may develop at any time, sometimes months after the start of HIV therapy. Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue or any new symptoms contact your doctor straight away.

Other side effects: In addition to peripheral neuropathy, the most frequent side effects observed in studies of adults taking the recommended dose of ZERIT were headache, diarrhea, rash, and nausea and vomiting. Other side effects may include abdominal pain, muscle pain, insomnia, loss of appetite, chills or fever, allergic reactions, blood disorders.