"GlaxoSmithKline (GSK) and FDA are notifying healthcare professionals and others of a potential association between Lexiva and myocardial infarction (heart attack) and dyslipidemia (abnormal concentrations of lipids or lipoproteins in the blood) i"...
Lexiva Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).
Tell your doctor right away if you have any serious side effects, including: increased thirst/urination, signs of a kidney stone (such as pain in side/back/abdomen, painful urination, blood in the urine).
Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.
Get medical help right away if you have any very serious side effects, including: signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).
Fosamprenavir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Lexiva (fosamprenavir calcium) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking fosamprenavir, tell your doctor or pharmacist if you are allergic to it or to amprenavir; or if you have any other allergies. This product may contain inactive ingredients (such as propylene glycol in the suspension), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (including hepatitis B or C infections), kidney problems (including kidney stones), heart problems (such as coronary artery disease, heart attack), diabetes, a certain bleeding problem (hemophilia).
Fosamprenavir may increase the level of cholesterol and fats (triglycerides) in your blood. HIV infection can also cause this effect. This could increase your risk for heart problems such as a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease such as high blood pressure, diabetes, or high cholesterol/triglyceride levels.
Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Children may be more sensitive to the side effects of this drug, especially vomiting and signs of infection (such as fever, persistent sore throat).
During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment can decrease the risk of passing the HIV infection to your baby. Fosamprenavir may be part of that treatment. Discuss the risks and benefits with your doctor.
It is unknown if fosamprenavir passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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