Zyprexa Goes Generic!

By Beth Isaac // October 28th, 2011 10:30 AM // No Comments

Great news! This week, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Zyprexa and Zyprexa Zydis for the treatment of schizophrenia and bipolar disorder. This isn’t just great news, it is incredible news! In 2010, Zyprexa was number 17 on the top 200 drugs in the U.S. market by sales, garnering almost three billion dollars in revenue, according to Pharmacy Times. The article went on to explain that generic drugs represented 78 percent of the total number of prescriptions dispensed in the United States last year.

According to a report, from the Centers for Disease Control and Prevention (CDC), on the burden of mental illness, bipolar disorder is the most expensive behavioral health care diagnosis, costing more than double what a diagnosis of depression costs an individual.  The economic burden of schizophrenia is typically greatest during the first year after the initial episode.

In our current economic environment, patients and providers are constantly searching for the most effective treatment options, while at the same time acutely aware of cost and spending. Prescribers are forced to choose between which treatment options best meets the needs of a patient and which options a patient can afford, if they can afford treatment at all. Here’s what you need to know about generic drugs, a quick summary of the FDA news release about generic olanzapine and, of course, The Bottom Line.

What Do You Need to Know About Generic Drugs?

  • Generic drugs approved by the FDA are therapeutically equivalent to the brand-name versions
  • Generic drugs have the same high quality, strength, purity and stability as the brand-name drugs
  • The manufacturing, packaging and testing sites for generic drugs must pass the same quality standards as the brand-name drugs

 

What Did the FDA Say?

  • The approval of generic olanzapine offers greater access to a widely used treatment option
  • The availability of affordable treatment options benefits patients with long-term conditions that must be carefully managed
  • Olanzapine must be dispensed with a Medication Guide outlining the risks and adverse reactions patients should be aware of when taking olanzapine
  • Olanzapine has a black boxed warning that the drug can increase the risk of death in elderly people who have psychosis resulting from confusion and memory loss

 

The Bottom Line

  • Generic olanzapine was approved to treat schizophrenia and bipolar disorder
  • Olanzapine is not approved for treating psychosis in elderly people who have dementia
  • Serious reactions may include high blood sugar, increased cholesterol and triglycerides, and weight gain
  • Generic olanzapine tablets will be manufactured by Dr. Reddy’s Laboratories Ltd. and Teva Pharmaceuticals USA
  • Generic olanzapine orally disintegrating tablets will be manufactured by Apotex Inc., Dr. Reddy’s Laboratories Ltd., and Par Pharmaceuticals Inc.

 

Posted In: FDA Updates, General Health, New Drugs
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Two Problems, One Solution!

By Beth Isaac // October 21st, 2011 10:00 AM // 1 Comment

Are you ready for some breaking news? Two weeks ago, the U.S. Food and Drug Administration (FDA) approved Juvisync, the first combination drug to treat type 2 diabetes AND high cholesterol in one tablet. Oh, you heard me right! This is great news for millions of people. Do you know what this means? Two problems, one solution!

According to the Centers for Disease Control and Prevention (CDC), 8.3% of the U.S. population has diabetes and 16.3% of the U.S. adult population has high cholesterol. You’re probably asking yourself how many people account for 8.3 and 16.3 percent? I know I did. Well, it is estimated that approximately 26 million people in this country have diabetes. You do the math! With so many people affected by diabetes and high cholesterol in this country, it only makes sense that a drug company would finally come up with a pill that can treat both. The only thing I’m still wondering is what took them so long? Here are some fast facts about the new drug and, as always, the bottom line. Is Juvisync right for you? Read on and then chat with your doctor!

Why is Juvisync Important?

  • Some 20 million people in the United States have type 2 diabetes and many have high cholesterol as well
  • When left untreated, or poorly treated, these two conditions can increase the risk of heart disease, stroke, kidney disease and blindness, as well as other chronic medical conditions

 

Juvisync Fast Facts

  • First combination drug for type 2 diabetes and high cholesterol formulated in one tablet
  • Fixed-dose combination medication containing two previously approved medications, sitagliptin and simvastatin
  • Juvisync should only be prescribed when a patient requires treatment with both drugs
  • Recommended starting dose is usually 100 mg/40 mg once daily in the evening
  • Swallow Juvisync tablets whole. Do not break, crush, cut, dissolve or chew Juvisync tablets

 

The Bottom Line

  • Juvisync is indicated for patients for whom treatment with both sitagliptin and simvastatin is appropriate
  • The most common side effects include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation and nausea
  • Juvisync is available in 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg tablets
  • Juvisync is marketed by Merck & Co., Inc.
Posted In: General Health, New Drugs
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To Split or Not To Split: That is the Question!

By Beth Isaac // October 14th, 2011 10:00 AM // 1 Comment

With an unstable economy and a troubling recession, many people try to cut corners and save money whenever and wherever possible. Unfortunately, this doesn’t only happen at the grocery store, but at pharmacies as well. While saving a few dollars by purchasing the store brand of eggs or cereal isn’t such a bad idea these days, trying to save a few dollars by splitting pills may be more dangerous.

So the question remains, to split or not to split? Many medications are safe to split in half, those of which are typically scored. You know, the ones with the line down the middle? While other medications, especially certain cholesterol and blood pressure medications, some of the more costly, are actually dangerous to split in half.

Physicians or insurance companies sometimes recommend their patients split tablets for easy dosage adjustments or as a cost saving measure. This increasingly prevalent and, often times, unsafe practice of pill-splitting has led the U.S. Food and Drug Administration (FDA) to take notice.

Why Pill-Splitting May Be Risky

  • Accidental doubling of dosage if the patient forgets to split a higher dosage tablet
  • Certain tablets are difficult to split perfectly, causing uneven distribution of medication
  • Crumbling and breakage may occur if tablets are small, or unusually shaped, causing inaccurate dosing
  • Not all tablets are safe to split! Capsules, coated and controlled-release tablets are not safe to split and should ALWAYS be swallowed whole

FDA Tips and Best Practices for Safe Tablet Splitting

  • To check if your pills are FDA-approved to be split, check the “How Supplied” section of the package insert, or ask your pharmacist
  • Don’t split your entire supply of tablets at once, split the tablet just before taking your dose; split tablets can be affected by heat, humidity and moisture
  • Talk to your doctor or pharmacist about the best method to split your medication; usually a tablet splitter
  • If you take a generic medication, check with your pharmacist if you receive a tablet made by a different manufacturer to be sure it is still safe to split (tablets made by different manufacturers can have different color or shape)

The Bottom Line

  • Talk to your doctor or pharmacist before splitting tablets
  • Not all tablets are safe to split
  • For approved drugs, always use a tablet splitter to ensure accurate dosing!

 

Posted In: General Health
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New Instructions for Tylenol-Coming Fall 2011 to a Pharmacy Near You!

By Beth Isaac // October 5th, 2011 10:00 AM // No Comments

Acetaminophen is one of the most commonly used medications in the United States for treating pain and fever, according to the U.S. Food and Drug Administration (FDA).

In late summer 2011, McNeil, the manufacturer of Extra Strength Tylenol, announced plans for new dosing instructions beginning in Fall 2011. The change in dosing instructions will lower the maximum daily dose recommended for Tylenol products sold in the United States. The dosing changes affect single-ingredient Extra Strength Tylenol products. The proposed change includes lowering the maximum daily dose from 4000 mg per day to 3000 mg per day, or from eight tablets per day to six tablets per day. The dosing interval will also change from two tablets every four to six hours to two tablets every six hours.

Acetaminophen, the active ingredient in Tylenol, can be found in more than 600 over-the-counter and prescription medications including Tylenol, Sudafed, NyQuil, Percocet and Vicodin, just to name a few. If taking multiple products, patients often don’t realize they contain acetaminophen and accidentally take more than the recommended dose.

Why is McNeil changing the dosing instructions?

McNeil announced these changes to ensure the appropriate usage of acetaminophen products and in an effort to decrease the risk of accidental overdose, which still remains a serious public health problem.

The Bottom Line

  • Change in dosing instructions not mandated by the FDA
  • New dosing instructions will appear on Extra Strength Tylenol packaging in the United States beginning Fall 2011
  • According to McNeil, dosing instructions will change for Regular Strength Tylenol and other McNeil products beginning in 2012
  • McNeil is working with other manufacturers of acetaminophen products in an effort to ensure consistency in dosing instructions
  • New dosing instructions will change to two tablets every six hours; maximum daily dose six tablets per day
  • Talk to your doctor or pharmacist about the medications you take, to avoid taking more acetaminophen than is recommended
  • Excess amounts of acetaminophen can cause liver damage
  • When taken as directed, acetaminophen is safe!
Posted In: General Health
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