Tuesday, June 28, 2011

ZOCOR (Simvastatin) WARNING

Notice


[Posted 06/08/2011] ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) [Zocor] because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.



BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).



RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.


What other information should I know?


Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your response to simvastatin.



Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.



It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.





American Society of Health-System Pharmacists, Disclaimer




National Center for Biotechnology Information, U.S. National Library of Medicine


8600 Rockville Pike, Bethesda MD, 20894 USA

Tuesday, January 18, 2011

FDA Restricts Acetaminophen in Some Products .

By ALICIA MUNDY


WASHINGTON—Federal health regulators are restricting the amount of acetaminophen in prescription painkillers such as Vicodin and Percocet because of concerns that acetaminophen overdoses are linked to thousands of cases of liver damage in recent years.



The Food and Drug Administration said Thursday it will ask manufacturers to limit acetaminophen used in combination prescription drugs to 325 milligrams. The agency is also asking drug makers to add the strongest warning—a black box—to their labels about the possibility of severe liver damage.



Federal health regulators are asking manufacturers to restrict the amount of acetaminophen in prescription painkillers because of concerns over accidental overdoses when people combine them with over-the-counter drugs. WSJ's Alicia Mundy reports.

.Acetaminophen is a widely used pain reliever found in many popular over-the-counter medicines such as Tylenol and NyQuil, which treat headaches, sore throats, fevers and muscle aches. The dosage in Johnson & Johnson's over-the-counter Extra Strength Tylenol and other extra-strength generic versions is 500 milligrams.



FDA officials said people may accidentally overdose on acetaminophen when they take it in prescription combinations with opioid narcotics and then take additional over-the-counter acetaminophen. For example, a patient using Vicodin, which contains acetaminophen, for a back injury may also ingest acetaminophen for a headache.



However, when taken in recommended dosages, "acetaminophen is a very safe product," said the FDA's Sandra Kweder, deputy director of the office of new drugs.



Acetaminophen overdoses connected to prescription combination painkillers account for nearly half of all cases of acetaminophen-related liver failure in the U.S., many of which result in liver transplant or death, FDA officials said.



The FDA said companies will phase in lower doses of acetaminophen in their prescription combinations over the next three years.



The FDA isn't taking any action at present on over-the-counter medicines. "We're continuing to consider a full spectrum of options for over-the-counter products," Dr. Kweder said.



A spokeswoman for Johnson & Johnson declined to discuss possible changes to over-the-counter Tylenol.



The company also makes three prescription combinations using acetaminophen. Two contain 325 milligrams of acetaminophen, while a third, Tylox, has 500 milligrams of that drug, said J&J spokesman William Foster. "With Tylox, we are evaluating our next steps and will discuss with FDA," he said.



The FDA move stems from a June 2009 advisory committee meeting in which the agency's outside experts on pain medicines and drug safety voted overwhelmingly for a black-box warning on Vicodin and the other combination painkillers.



The panel split on whether Vicodin and Percocet should be pulled from the market.



One of the panelists from that meeting, neurologist John Markman of the University of Rochester Medical Center, said, "The FDA struck a great balance in their decision not to pull the medicines." Dr. Markman, who runs the university's neuromedicine pain center, added, "They are very necessary in palliative care, in end-of-life care, and treating chronic pain."



The FDA considered an outright ban on the combination medicines, but rejected that, said Dr. Kweder.



Write to Alicia Mundy at alicia.mundy@wsj.com



Copyright 2011 Dow Jones & Company, Inc. All Rights Reserved

Thursday, June 17, 2010

Mackey Family Practice Recieves NCQA Certification

The National Committee for Quality Assurance is a private, 501(c)(3) not-for-profit organization dedicated to improving health care quality. Since its founding in 1990, NCQA has been a central figure in driving improvement throughout the health care system, helping to elevate the issue of health care quality to the top of the national agenda.


The NCQA seal is a widely recognized symbol of quality. Organizations incorporating the seal into advertising and marketing materials must first pass a rigorous, comprehensive review and must annually report on their performance. For consumers and employers, the seal is a reliable indicator that an organization is well-managed and delivers high quality care and service.

NCQA has helped to build consensus around important health care quality issues by working with large employers, policymakers, doctors, patients and health plans to decide what’s important, how to measure it, and how to promote improvement. That consensus is invaluable — transforming our health care system requires the collected will and resources of all these constituencies and more.

TYELNOL RECALL

June 15, 2010



Dear Healthcare Professional:

I am writing to inform you that McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling five product lots as an addition to the list of products included in the company's January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is being conducted with the knowledge of the U.S Food and Drug Administration. McNeil is providing the following information to consumers on the www.mcneilproductrecall.com Web site.



MCNEIL CONSUMER HEALTHCARE RECALLS FOUR PRODUCT LOTS OF BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 COUNT, AND ONE PRODUCT LOT OF EXTRA STRENGTH TYLENOL® RAPID RELEASE GELS, 50 COUNT

Fort Washington, PA (June 15, 2010) - McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company's January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW). This recall is a follow-up to the product recall that McNeil Consumer Healthcare announced on January 15th, 2010 and is being taken because the products were inadvertently omitted from the initial recall action. McNeil Consumer Healthcare identified the omission and informed the U.S. Food and Drug Administration (FDA) of its decision to add these product lots to the recall list. All of these products were produced before the January 15th, 2010 recall. Since January, McNeil Consumer Healthcare has continued to analyze and evaluate 2,4,6-tribromoanisole (TBA) and has shared that information with the FDA. This further analysis confirms that the risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the FDA.

BENADRYL® ALLERGY ULTRATAB™ TABLETS is sold over-the-counter and is indicated for the relief of allergy associated symptoms such as sneezing, runny nose, itchy throat, and itchy and watery eyes. EXTRA STRENGTH TYLENOL® Rapid Release Gels is sold over-the-counter and is indicated for the temporary reduction of fever and for the temporary relief of minor aches and pains due to headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, pre-menstrual and menstrual cramps, and flu.

The January 15th, 2010 recall was initiated as a result of consumer complaints of a musty or moldy odor that has since been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a thorough investigation, it was determined that the source of TBA was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials.

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Requests for reimbursement can be made at www.mcneilproductrecall.com. Consumers who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/safety/medwatch/default.htm.

The product lot numbers for the recalled products can be found on the side of the bottle label.



If you have any questions yourself, please call our Medical Affairs Department at 1-866-948-6883 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time) or visit our dedicated Web site for Healthcare Professionals at TylenolProfessional.com.

Sincerely,



Edwin K. Kuffner, MD

Vice President, Medical Affairs

McNeil Consumer Healthcare

FULL RECALLED PRODUCT LIST:

Product Code Product Name Lot Number UPC Code

TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAPS

4885000 TYLENOL® EXTRA STRENGTH RAPID RELEASE GELCAPS 50 ct
BENADRYL® ALLERGY ULTRATAB™ TABLETS

1703302 BENADRYL® ALLERGY ULTRATAB™ Tablets 100 ct





You are receiving this email because you have opted-in to receive communications from McNeil Consumer Healthcare. Please do not respond to this email, since it is not enabled to process responses. If you have any questions, email us or call us at 1-866-948-6883, Monday through Friday, 9 am to 4:30 pm EST. Also, please add info@TylenolProfessional.com to your address book or email safelist so that future emails from us can reach you.

If you do not wish to receive future communications from TylenolProfessional.com, you can unsubscribe.



7050 Camp Hill Road

Fort Washington, PA 19034, USA

©McNEIL-PPC, Inc. 2010

Thursday, May 6, 2010

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products


McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children's and Infants' liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.



McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.



The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.



Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.



For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Wednesday, April 21, 2010

Diabetic Education Class

We had a great turnout for our class on diabetes that was held on April 15, 2010.  The crowd was very interactive with questions during this session.
     We  learned about good blood sugar control.  What is diabetes, meal planning and physical activity and special situations. Information to take home was give to each participant about knowing and understaning your treatment for your diabetes.
     We look forward to our next Diabetic class which is scheduled for May 20, 2010 at 2pm in the Mackey Family Practice Educational Center.  To register for this class please contact our office at 803-285-7414.  We look forward to seeing you there.
    

Tuesday, April 13, 2010

Weight Management

     We had a great time at our WEIGHT MANAGEMENT class on April 8, 2010.  There were 15 in attendance.
     We learned that in order to lose weight we must eat a diet low in fat and carbohydrates, and control our portion sizes.  We must also make better choices when it comes to food selections.  Some recommendations would be to eat more fresh fruits and vegetables and DON'T SNACK BETWEEN MEALS.
     We also learned the benifits of regular exercise.  Just 30 minutes a day of moderate exercise can reduce our risk of diseases such as:  Diabetes, heart disease, cancer, dementia and strokes.  THAT'S RIGHT.....JUST 30 MINUTES A DAY!!
  So let's GET UP AND MOVE.  YOU are the ONLY one in control of YOUR body.  YOU control what goes in your mouth and whether you are going to exercise or not.  No one can make these decesions for you.
     A special word of thanks is extended to Lori Mosley, NP  from the Gregory Health and Wellness Center and Eddie Haughy from Anytime Fitness for a very informative class.

For more information regarding other FREE classes at Mackey Family Practice please visit our website http://www.mackeyfamilypractice.com/ or contact our office at 803-285-7414.