Corifact Approved by FDA
February 21, 2011 | 
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***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.
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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
Non-profit Medication Information Website
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**
Drug Misuse amongst Teens
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 12th 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?
Cold Medicine Recall
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
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