House Committee Seeks Information On Marketing, 'Bundling' Contracts Related To Anemia Medications

The House Energy and Commerce Committee has asked Amgen and Johnson & Johnson to submit information on marketing and " bundling " contracts related to anemia medications, which reports have linked with increased risk for death when administered at high doses, Bloomberg/Boston Globe reports.

The committee has requested information on the amount that J&J has spent on direct-to-consumer television and print advertisements for the anemia medication Procrit since 2001. In addition, the committee seeks an explanation of decision by J&J to discontinue ads for Procrit in 2005.

The committee has requested different information from Amgen, which doesn't market anemia medications Epogen and Aranesp directly to consumers. The committee seeks copies of contracts under which Amgen provided discounts on Neupogen and Neulasta, medications that increase white blood cell production in cancer patients who receive chemotherapy, to physicians who prescribed Aranesp. The committee also has requested copies of TV and print ads for Neupogen and Neulasta.

In a March 31 letter to Amgen CEO Kevin Sharer, committee Chair John Dingell ( D-Mich. ) wrote, " We're concerned that such 'bundling' practices may have helped fuel excessive and dangerous off-label use of Aranesp. '

Kassy McGourty -- a spokesperson for J&J subsidiary Ortho Biotech, which markets Procrit -- in an e-mail wrote, " We have received the letter from House Committee on Energy and Commerce and will continue to cooperate fully with committee's requests. " Amgen didn't immediately respond to an e-mail request for comment ( Bloomberg/Boston Globe , 4/1 ) .

Reprinted with kind permission from http: //www. kaisernetwork. org. You can view entire Kaiser Daily Health Policy Report, search archives, or sign up for email delivery at http: //www. kaisernetwork. org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork. org, a free service of The Henry J. Kaiser Family Foundation 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Avandia: useful modern medicine.

Avandia: uses

Avandia is an anti-diabetic drug ( thiazolidinedione-type, also called " glitazones " ) used with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes ( non-insulin-dependent diabetes ) . Avandia works by helping to restore your body's proper response to insulin, thereby lowering your blood sugar. Effectively controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness, and circulation problems, as well as sexual function problems ( impotence ) .

Avandia is used either alone or in combination with other anti-diabetic medications ( e. g. , metformin, sulfonylureas, insulin ) .

Avandia: how to use

Read the Patient Information Leaflet available from your pharmacist before we start taking Avandia and each time we get a refill. If you have any questions, consult your doctor or pharmacist.

Take Avandia by mouth, with or without food, usually once or twice daily, or as directed by your doctor. Dosage is based on your medical condition, response to therapy, and if we are taking other anti-diabetic drugs.

Use Avandia regularly in order to get the most benefit from it. Remember to use it at same time ( s ) each day. Monitor blood glucose levels on a regular basis.

It may take up to 2 to 3 months before full benefit of Avandia takes effect.

Take all other medications for diabetes as directed by your doctor.

Avandia: side effects

See also Warning section.

Headache or cough may occur while use Avandia. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Avandia because he or she has judged that benefit to we is greater than risk of side effects. Many people using Avandia do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur:

Avandia usually doesn't cause low blood sugar ( hypoglycemia ) , but this effect may occur while use Avandia if you don't consume enough calories ( from food, juices, fruit, etc. ) . The symptoms include chills, cold sweat, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where we don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and don't skip meals.

Symptoms of high blood sugar ( hyperglycemia ) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.

A serious allergic reaction to Avandia is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

This is not a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

Avandia: precautions

Before taking Avandia, tell your doctor or pharmacist if you're allergic to it; or to other " glitazones " such as pioglitazone; or if we have any other allergies.

Promptly talk with your doctor or pharmacist about benefits and possible risks of Avandia, even if we have been taking it for awhile, especially if we have heart problems. Don't stop taking it unless directed to do so.

Avandia shouldn't be used if we have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

Before using Avandia, tell your doctor or pharmacist your medical history, especially of:

We may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels; use caution engaging in activities requiring alertness such as driving or using machinery.

Limit alcohol while taking Avandia because it can increase risk of your blood sugar getting too low ( hypoglycemia ) .

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as additional medication may be required.

Avandia may increase risk of bone fracture ( upper arm, hand, foot ) in female patients. To lower chance of getting injured, use caution when doing activities such as contact sports.

Avandia can cause changes in menstrual cycle ( ovulation ) in women with certain fertility problems. Consult your doctor or pharmacist about use of reliable birth control while taking this medication.

Avandia should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for Avandia during your pregnancy. Follow all instructions carefully.

It's unknown if Avandia passes into breast milk. Breast-feeding while using Avandia isn't recommended. Consult your doctor before breast-feeding.

Avandia: interactions

Your healthcare professionals ( e. g. , doctor or pharmacist ) may already be aware of any possible drug interactions and may be monitoring we for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using Avandia, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

Beta-blocker medications ( e. g. , metoprolol, propranolol, glaucoma eye drops such as timolol ) may prevent fast/pounding heartbeat we would usually feel when your blood sugar level falls too low ( hypoglycemia ) . Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

This document doesn't contain all possible interactions. Therefore, before using Avandia, tell your doctor or pharmacist of all products we use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

Avandia: overdose

If overdose of Avandia is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Avandia: notes

Don't share Avandia with others.

It is recommended we attend a diabetes education program to understand diabetes and all important aspects of its treatment including meals/diet, exercise, personal hygiene, medications and getting regular eye, foot and medical exams.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, eating well-balanced meals containing adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor to see if we need to take calcium/vitamin D supplements and discuss lifestyle changes that might benefit you.

Keep all medical appointments. Laboratory and/or medical tests ( e. g. , liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts, blood cholesterol levels ) will be performed to monitor for side effects and response to therapy. Regularly check your blood or urine for sugar, as directed by your doctor or pharmacist.

Avandia: missed dose

If we miss a dose Avandia, use it as soon as we remember. If it's near time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double dose of Avandia to catch up.

Avandia: storage

Store Avandia at room temperature at 77 degrees F ( 25 degrees C ) away from light and moisture. Brief storage between 59-86 degrees F ( 15-30 degrees C ) is permitted. Do not store Avandia in bathroom. Keep all medicines away from children and pets.

Properly discard Avandia when it's expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Avandia: warning

Avandia may infrequently cause or worsen a certain heart problem ( congestive heart failure ) . Tell your doctor immediately if we notice any symptoms of heart failure, including: swelling of hands/feet, unusual/sudden weight gain, trouble breathing, or unusual tiredness.

Avandia with worldwide delivery

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