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Posts Tagged ‘Pharmacy’

FDA Alert – Label Change: Tamiflu (oseltamivir phosphate) for Oral Suspension – New Concentration (6 mg/mL)

Posted by 4love2love on July 24, 2011

July 11, 2011
Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012).

ISSUE: Labeling changes are being made to Tamiflu oral suspension to reduce the possibility of prescribing and dosing confusion that can lead to medication errors.  The changes to the product label include:

  • A change in the concentration of Tamiflu from 12 mg/mL to 6 mg/mL. The lower concentration of Tamiflu is less likely to become frothy when shaken, which helps to ensure an accurate measurement. A change in the measurements of the oral dosing device from milligrams (mg = weight) to milliliters (mL = volume).
  • A change in the dosing table for Tamiflu to include a column for the volume (mL) based on the new 6 mg/mL concentration. Revised container labels and carton packaging. Revised compounding instructions for pharmacies to prepare a 6 mg/mL oral suspension from Tamiflu capsules in an emergency situation only if the commercially manufactured Tamiflu for oral suspension is unavailable.

BACKGROUND: Tamiflu is in a class of medications called neuraminidase inhibitors. These drugs work by stopping the spread of the influenza (flu) virus in the body. Genentech, the manufacturer of Tamiflu for oral suspension, plans to begin distribution of the new 6 mg/mL product in July 2011.  The company has instituted a voluntary Take Back Program for wholesale buyers, distributors and pharmacies to remove the 12 mg/mL product from the marketplace. The 12 mg/mL product will remain in the marketplace and in state or national stockpiles until current supplies expire.

RECOMMENDATION: It is important for healthcare professionals to be aware that a patient may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). Steps should be taken to avoid the potential for a medication error due to confusion between the two concentrations. Prescribers should include the new concentration (6 mg/mL) and dose in milliliters on all prescriptions for Tamiflu for oral suspension.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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WebMD – You Can Start Feeling Better: 8 Important Things to Do About Depression

Posted by 4love2love on July 18, 2011

Fears and Facts About Antidepressants

WebMD Medical Reference

By Mary Anne Dunkin

Reviewed By Brunilda Nazario, MD

Along with counseling, antidepressants are a common part of treatment for depression. And they are usually effective. Six out of 10 people treated with antidepressants feel better with the first one they try. If the first antidepressant medication doesn’t help, the second or third often will. Most people eventually find one that works for them. Yet many people who could benefit from an antidepressant never try one, often because of fears and misconceptions about them, experts say.

Here are eight common fears about antidepressants, as well as facts that can help you decide if an antidepressant might be right for you.

Fear: Antidepressants make you forget your problems rather than deal with them.

Fact: Antidepressants can’t make you forget your problems, but they may make it easier for you to deal with them. Being depressed can distort your perception of your problems and sap you of the energy to address difficult issues. Many therapists report that when their patients take antidepressants, it helps them make more progress in counseling.

Fear: Antidepressants change your personality or turn you into a zombie.

Fact: When administered correctly, antidepressants will not change your personality. They will help you feel like yourself again and return to your previous level of functioning. (If a person who isn’t depressed takes antidepressants, they do not improve that person’s mood or functioning.) Rarely, people experience apathy or loss of emotions while on certain antidepressants. When this happens, switching to a different antidepressant may help.

Fear: Taking an antidepressant will make me gain weight.

Fact: Like all drugs, antidepressants have side effects, and weight gain can be a common one of many of them. Some antidepressants may be more likely than others to cause weight gain; others may actually cause you to lose some weight. If this is a concern, talk with your doctor.

Fear: If I start taking antidepressants, I’ll have to take them for the rest of my life.

Fact: Most people who take antidepressants need to take them continuously for six to nine months – not necessarily a lifetime. Once an antidepressant gets depression under control, you should work with your doctor to decide when to stop your medication and then decrease your dose gradually. Discontinuing them suddenly may cause problems such as headaches, dizziness, and nausea.

Fear: Antidepressants will destroy my sex life.

Fact: Antidepressants can have an effect on sexual functioning. The problem is usually an inability to achieve orgasm rather than a lack of desire. But because depression itself decreases libido, a medication that eases depression may improve your sex life. As with other side effects, certain antidepressants may be more likely than others to cause sexual problems.

Fear: Antidepressants are expensive and aren’t covered by insurance.

Fact: Antidepressants are usually covered by insurance plans with prescription drug coverage. The cost of antidepressant therapy varies widely, depending on the dosage, the drug you are taking, and whether it is available as a generic. Even without insurance coverage, it is possible to purchase a generic antidepressant for as little as $15 per month.

Fear: Taking an antidepressant is a sign of weakness.

Fact: Like medical conditions such as diabetes or high cholesterol, major depression is a condition that often responds to medication.When depression interferes with your ability to function normally, seeking treatment is not a sign of weakness. It’s a sign of good self-care.

Fear: Antidepressants increase the risk of suicide.

Fact: Studies in recent years have raised concerns that antidepressants may raise the risk of suicide among children, adolescents, and young adults. For example, a 2009 review in the British Medical Journal (BMJ) analyzed 372 studies involving nearly 100,000 people who were taking antidepressants. It found that compared to placebo, use of antidepressant drugs was associated with a small increased risk for suicidal thoughts in some children and young adults, have no effect on suicide risk among those 25 to 64, and reduce risk in those 65 and older.

In 2004, the FDA required manufacturers of antidepressants to revise their labels to include a black box warning statement about these risks.

Other studies paint a different picture. A 2006 study published in PLoS Medicine suggests that the use of antidepressants has saved thousands of lives. Data show that the U.S. suicide rate held fairly steady for 15 years prior to the introduction of the widely used antidepressant fluoxetine (Prozac) and then dropped steadily over 14 years while sales of Prozac rose. The research team found the strongest effect among women.

The bottom line: Regardless of your age or sex, it’s important to see a doctor immediately if you have suicidal tendencies or witness them in others.

 

© 2010 WebMD, LLC.

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