***NEW DRUG ALERT *** As always, in our strive to make medicine simple, part of the initiative is to connect consumers to new medications in the market, while serving as a resource to answer your medication-related questions. For those individuals who suffer from a rare genetic congenital Factor XIII deficiency, you will be happy to learn the US Food and Drug Administration have approved a new medication on February 17, 2011.

Corifact, as noted by the FDA, is the first drug intended to prevent bleeding in people with the rare genetic defect. This deficiency affects 1 out of every 3 million to 5 million people in the United States. Hit the link for additional details regarding the deficiency. If you desire more information, do not hesitate to reach out to your healthcare provider or one of our clinical pharmacists.

More Information  

Updated Acetaminophen (eg, Tylenol) information:  The FDA will now require manufacturers to limit the amount of acetaminophen in products to 325mg. 

In the past, products for adults have contained doses of 325mg, 500mg, and even 650mg.  The FDA ‘believes that limiting the amount of acetaminophen per tablet, capsule, or other dosage unit in prescription products will reduce the risk of severe liver injury from acetaminophen overdosing, an adverse event that can lead to liver failure, liver transplant, and death.’   

Part of the problem is that many people only look for the product name ‘acetaminophen’ and fail to pay attention to the dosage amount.  The maximum amount of acetaminophen for most adults is 4gm (or 4000mg).  If the typical person takes the usual dose of 325mg every 4 to 6 hours, then half of the dosing limit would be reached.  However, if someone is in a lot of pain and takes 2 of the 650mg tablets every 4 hours (that’s 6 times per day), then this person could take up to 7800mg.  This is close to double the maximum amount.  This is why people are mistakenly overdosing on acetaminophen.  This can cause severe liver damage or liver failure requiring a liver transplant.  Very concerning…  

Take care, Dr. N

The National Library of Medicine has created a public website to provide medication-specific information for the public.  This website is not-for-profit and has no advertisements.  The website pulls information from the medication package insert and sorts it in an easy to read manner.  Simply type the name of your medication into the search tool. 

To use, click on:  http://dailymed.nlm.nih.gov/dailymed/about.cfm.  Additional information is on the website as well.    Take care, Dr. N 

**Together we can make medicine simple**

The United States Department of Health and Human Services National Institute of Health just released some information which some may find interesting. It is a change from our postings, which usually deal with medication news, medication safety, and overall medication management, however, news such as this is noteworthy as well.

A recent survey report released on December 14, 2010, indicates the rate of eighth-graders saying they have used an illicit drug in the past year jumped up to 16 percent, which is up from 14.5 percent the previous year. The survey also indicates teens are dropping cigarettes, and engaging in more illicit drugs such as marijuana. This trend is harmful because high rates of marijuana use during teen and pre-teen years when the brain continues to develop places young people at risk according to Dr. Nora D. Volkow.

Also included in the report is the prevalence of prescription drug abuse. Six of the top 10 illicit drugs abused by 12^th graders in the year prior to the survey were prescribed or purchased over the counter. Research also leads us to believe teens generally get these prescription drugs from friends and family, whether given, bought, or stolen. Please take a time to read the article, and leave your comments below. Do you have any ideas on how we can prevent prescription drug abuse amongst our teens?

Reese Pharmaceutical Company has voluntarily recalled 60-count size bottles identified under four different brand names. These brand names are: Refenesen Expectorant (guaifenesin 200 mg tablets), Select Brand Mucus Relief Expectorant (guaifenesin 200 mg), QC Medifin Expectorant (guaifenesin 200 mg), and Leader Cough Tabs Expectorant (guaifenesin 200 mg)

The reason for the recall was due to a mislabeling on the medications. These particular medications contain 325 mg of Acetaminophen; however, the aforementioned bottles fail to provide a warning explaining to consumers, ingesting high doses of Acetaminophen can potentially cause severe liver damage.

As we all know, the cold season is upon us, and once again, many of us are flocking to pharmacies, physicians, or clinics for either our flu shots, or cold medicines to cure flu-like symptoms, such as runny noses, coughs, and/or sore throats. Practicing effective medication management strategies prevents the type of medication errors, which injure 1.5 million people every year. 

Please also keep in mind 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 formor 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

FDA officials estimate 100,000 Americans are currently using a pill known as Meridia. Meridia (sibutramine) was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. A clinical trial data indicates an increased risk of heart attack and stroke. The trial in question demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, and the need to be resuscitated once the heart stopped, and death, in a group of patients given Meridia compared to another substance, which acted as a placebo.  Previous recommendations suggested this particular drug to be used in combination with a reduced calorie diet and exercise to help people who are overweight lose weight and maintain their weight loss. 

Abbot Laboratories manufacturing and distribution of Meridia faced problems from the beginning, due to issues such as raising both blood pressure and heart rate. Consumers and health care professionals are encouraged to report adverse events related to Meridia (sibutramine) capsules to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm or by phone at 800-FDA-1088 (800-332-1088).

A new Avandia and Actos study published in the medical journal Circulation: Cardiovascular Quality and Outcomes, on August 24, 2010 reveals Takeda Pharmaceuticals Actos and GlaxoSmithKlines Avandia raised the risk of heart problems by 4%.

The study consisted of 36,000 diabetes patients who used Avandia or Actos to treat the chronic condition diabetes. Of the 36,000 diabetes patients, 602 who took Avandia suffered heart problems or died, while 599 of those taking Actos had heart problems or died.

Avandia (Rosiglitazone) and Actos (Pioglitazone) is used to treat Type 2 Diabetes (a condition in which the body does not use insulin normally and, therefore cannot control the amount of sugar in the blood). Unfortunately, these medications may also cause some side effects, such as water retention, swelling of the ankles, weight gain, muscle weakness, and fatigue.

As a health educator working with clinical pharmacists, we commonly see patients who use these types of medications, and need answers for their medicine questions. As always, make sure you carefully read the ‘Drug Facts Label’ on the back of all medications, and consult a health care professional when it comes to managing your medications.

In our effort to make medicine simple, and educate the public on the type of medication errors/problems, which injure 1.5 million people, every year, we wanted to pass along some quick information regarding a recent FDA alert. Individuals taking Lamictal or Healthcare professionals who prescribe Lamictal should be aware the FDA issued a “drug safety communication,” indicating the Warnings and Precautions section on the drug label will be updated to list “aseptic meningitis” as a potential side effect.

For those not aware, aseptic meningitis is an inflammation of the protective membranes covering the brain and spinal cord that is not caused by any detectable bacteria. In addition, Meningitis is considered a medical emergency due to its proximity to the brain. Research shows if this condition remains untreated, it can result in deafness, cognitive problems, and epilepsy.

Lamictal is prescribed to more than 46 million people every year for treatment of epilepsy and bipolar disorder. The FDA recommends, those taking Lamictal, who experience symptoms such as headaches, neck stiffness, fever, confusion, vomiting, or light sensitivity to contact their healthcare professional. If you are looking for general medicine questions, do not hesitate to contact our clinical pharmacists.

Tylenol (Brand Name), otherwise known as acetaminophen, is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds, sore throats, toothaches, backaches, and reactions to vaccinations (shots).  In addition, this particular medication is sometimes used to relieve the pain of osteoarthritis.

In a recent study, published in the American Journal of Respiratory and Critical Care Medicine, acetaminophen, is said to be linked to higher risks of asthma, allergic nasal conditions, and eczema.

The study consisted of roughly 320,000 kids ages 13 and 14 in 50 countries who take acetaminophen. Clinical trials revealed, children who take acetaminophen are more than twice as likely to have asthma as teens the same age and who have never taken the common over-the-counter medication.

More detailed results reveal, those who participated in the study, and took acetaminophen at least once per year were 43% more likely to have asthma. In addition, those who took acetaminophen at least monthly were 2.5 times as likely to suffer from the condition.  The FDA has not yet released a statement in response to this data. 

As a clinical pharmacist, we commonly see patients who use these types of medications.  It is a reality that we have needs that require self-medication and over-the-counter medications can be a big relief.  As always, make sure you carefully read the ‘Drug Facts Label’ on the back of all over-the-counter medications.  Pay attention to the active ingredient, directions for use, and warnings.  In addition, always discuss any over-the-counter medication use with your health care professional.

Another recall, and interestingly enough, is similar to the recall of another sexual performance drug located here. Prolatis’, a dietary supplement, is advertised on various websites as a “fast acting sexual performance enhancer.”

This particular dietary supplement is aimed towards men who are “experiencing a premature decline in sexual function.” However, Prolatis’ is currently issuing a voluntary nationwide recall of their product after being informed by the Food and Drug Administration (FDA) “that lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug.

As stated in our previous posting, the threat to consumers is based on the fact this undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to danger levels.

This is extremely possible for high-risk population groups such as those with diabetes, high blood pressure, high cholesterol, or heart diseases, since usually, these high-risk population groups are often taking nitrates.