Health Advisories
MONDAY, MAY 5, 2008
Digitek Recall. The Board is aware that Actavis Totowa LLC (formerly Amide Pharmaceuticals) has recalled various strengths of its Digitek digoxin tablets. A copy of the recall notice may be found here. Pharmacists are also aware that digoxin is a Narrow Therapeutic Index drug. Under North Carolina law:
A prescription for a narrow therapeutic index drug shall be refilled using only the same drug product by the same manufacturer that the pharmacist last dispensed under the prescription, unless the prescriber is notified by the pharmacist prior to the dispensing of another manufacturer's product, and the prescriber and the patient give documented consent to the dispensing of the other manufacturer's product. For purposes of this subsection, the term "refilled" shall include a new prescription written at the expiration of a prescription which continues the patient's therapy on a narrow therapeutic index drug.
N.C.G.S. Section 90-85.28(b1).
Board staff understands that the Digitek recall will require switching some patients to a different manufacturer’s digoxin product. Compliance with the letter of N.C.G.S. Section 90-85.28(b1) may prove difficult in certain circumstances. In the unusual circumstances of this recall, it is critical to ensure that patients continue to receive their medication. Accordingly, where switching a patient to a different manufacturer’s digoxin product is necessary because of the recall, pharmacists must counsel affected patients on the switch, the reason for it, and possible side effects/therapeutic changes that could be associated with the change. Moreover, pharmacists must contact the patient’s prescriber to alert of the change so that monitoring of digoxin levels and therapeutic effect can, if necessary, begin.
February 12, 2008
Health Alert from the FDA: PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25
mcg/hr Duragesic Patches sold in the United States. The product is being recalled
because the patches may have a cut along one side of the drug reservoir
within the patch which may result in the possible release of fentanyl gel that
may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl
is a potent Schedule II opioid medication and exposure to the gel may lead
to serious adverse events, including respiratory depression and possible
overdose, that may be fatal. Patches with a cut edge should not be used. These
recalled patches have expiration dates on or before December 2009 and are all
manufactured by ALZA Corporation.
Read the complete 2008 FDA MedWatch Safety Summary, including a link to the FDA Firm Press Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Duragesic
Bisphosphonate Use Can Cause Severe Musculoskeletal Pain, FDA Says
January 7, 2008
http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm
BETHESDA, MD, 07 January 2008 — Health care professionals whose patients use bisphosphonates should be aware that the drugs can cause severe musculoskeletal pain that may start after years of therapy, FDA announced today.
The agency noted that health care providers may overlook the association between severe musculoskeletal pain and bisphosphonate use, even though this information appears in the prescribing information for all seven FDA-approved bisphosphonates.
The problem described in FDA's announcement differs from the so-called acute pain response that occurs shortly after the initial administration of a bisphosphonate and typically resolves within days. The acute pain response is characterized by flu-like symptoms, such as fever and muscle and joint pain, FDA stated.
According to the agency, severe musculoskeletal pain may begin days, months, or years after a patient begins bisphosphonate treatment, and the pain can be incapacitating. Discontinuing therapy may cause the pain to subside completely, or it may resolve slowly or partially, FDA stated.
The agency recommended that health care providers consider bisphosphonate use as a possible cause of musculoskeletal pain in patients who report this symptom and consider temporarily or permanently halting bisphosphonate therapy in such patients.
If musculoskeletal pain fails to lessen or resolve after the therapy is discontinued, health care providers should seek another explanation for the pain, according to FDA.
The agency stated that it expects to finish its evaluation of reports of musculoskeletal pain in bisphosphonate users in about six months and will issue recommendations about managing the condition.
Today's announcement did not address FDA's ongoing review of a possible link between bisphosphonate use and serious atrial fibrillation. That investigation was announced last October, and FDA said at the time that the investigation would take up to a year to complete.
FDA Issues Additional Warnings Concerning Use of Fentanyl Patches
The Food and Drug Administration has again issued warnings concerning appropriate use of fentanyl patches. Pharmacists should be aware that the use of fentanyl patches can be dangerous in certain patient populations. Pharmacists should carefully refiew and update patient profiles prior to dispensing fentanyl patches. For more information, see http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentanyl
and the ASHP alert here.
December 14, 2007
FDA MedWatch Alert: Voluntary recall of eleven lots of PedvaxHIB and two lots of COMVAX vaccines
Merck & Co. and FDA informed healthcare professionals and consumers of a voluntary recall of eleven lots of PedvaxHIB and two lots of COMVAX vaccines. The vaccines were recalled because the manufacturer cannot assure sterility of the affected lots. Routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB and COMVAX identified the presence of Bacillus cereus bacteria. Sterility tests of the vaccine lots themselves have not found any contamination. The affected doses were distributed in the U.S. starting in April 2007. Healthcare professionals should immediately discontinue use of any of the affected lots and follow the manufacturer's instructions for returning recalled vaccines. See the FDA Consumer Update for a list of the specific lots of each vaccine recalled.
Read the complete MedWatch 2007 Safety Summary including a link to the FDA Consumer Update regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#PedvaxHIB
September 21, 2007
FDA MedWatch Alert: Nationwide recall of Axcil and Desirin
TWC Global LLC, Inc., issued a nationwide recall of Axcil and Desirin, both marketed as dietary supplements, because they contain potentially harmful, undeclared ingredients. FDA laboratory analysis of Axcil and Desirin found that the lot of 02B07 contained 3mg/g of sildenafil, the active ingredient of a FDA approved drug used for Erectile Dysfunction (ED). The products also contained sulfosildenafil and sulfohomosildenafil, which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sexual dysfunction is a common problem in men and women with these conditions, and consumers may seek these types of products to enhance sexual performance. Consumers who have these products should stop using them immediately and consult their healthcare professional if they experience any problems that may be due to these products.
Read the complete MedWatch 2007 Safety Summary including a link to the manufacturer's Recall Notice at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Axcil
August 17, 2007
FDA MedWatch Alert: Use of Codeine products by some breastfeeding mothers may lead to life-threatening side effects in nursing babies
FDA issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect codeine metabolism, including a person's genetic make-up. Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.
When prescribing codeine-containing drugs to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs. There is an FDA cleared test for determining a patient's CYP2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test predict that a person can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood. When levels of morphine are too high, patients have an increased risk of adverse events.
Read the complete MedWatch 2007 Safety summary, including a link to the FDA Public Health Advisory and Drug Information Page, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Codeine
August 14, 2007
FDA MedWatch Alert: Kaletra (lopinavir/ritonavir) Oral Solution - Dear Healthcare Provider Letter Regarding The Proper Dosing For Kaletra Oral Solution
Abbott Laboratories disseminated a Dear Healthcare Provider Letter throughout the world to physicians and pharmacists that prescribe/distribute Kaletra Oral Solution. The letter informed healthcare professionals of an accidental overdose that occurred with a pediatric patient taking Kaletra Oral Solution. The infant received a significantly large dose of Kaletra and subsequently died. Healthcare professionals should pay special attention to accurate calculation of the dose of Kaletra, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors.
Read the complete MedWatch 2007 safety summary including a link to the Manufacturer's Dear Healthcare Provider Letter and Prescribing Information regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#kaletra
August 1, 2007 - Botulism Associated with Canned Goods - Notice for NC Clinicians from the NC Department of Health & Human Services Division of Public Health. (Includes consumer alert placards in English and in Spanish.)
August 1, 2007 - FDA MedWatch Alert: FDA Raises Concerns Over The Continued Use Of Recalled Complete MoisturePlus Multipurpose Contact Lens Solution Manufactured By Advanced Medical Optics
FDA announced that many consumers may not be aware of the May 2007 recall of Complete MoisturePlus Multipurpose Contact Lens Solution manufactured by Advanced Medical Optics (AMO) and continue to use the recalled product. Several cases of Acanthamoeba Keratitis have been reported to CDC that involve the use of AMO Complete MoisturePlus after the recall was announced. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePlus product immediately, discard all remaining solution including partially used or unopened bottles. See the FDA Preliminary Public Health Notification dated May 31, 2007, for recommendations for contact lens wearers.
Read the complete MedWatch 2007 Safety Summary including a link to the FDA News Release and Preliminary Public Health Notification regarding this topic at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#AMO
ATTENTION PHARMACISTS and PRESCRIBERS: OMACOR BECOMES LOVAZA
In response to an FDA request, Reliant Pharmaceuticals is changing the name of the drug Omacor to Lovaza because of a chance of a misfill with Amicar.
July 5, 2007
FDA MedWatch Alert: Merck Recalls 3 Lots Of Invanz (ertapenem sodium) Injection
Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated microorganisms, were recalled. The product was recalled because of two incidents of finding broken glass pieces in the reconstituted solution for injection. Healthcare professionals are advised to immediately stop dispensing all products from the three lots specified above. No other lots are affected by this recall.
Read the complete MedWatch 2007 Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Invanz
May 10, 2007
FDA MedWatch Alert: True Man and Energy Max Products Health Risk Alert
FDA informed consumers and healthcare professionals regarding the dangers associated with the purchase or use of True Man or Energy Max products promoted and sold as dietary supplements throughout the United States. Both products, promoted as sexual enhancement products and as treatment for erectile dysfunction (ED), are illegal drug products that contain potentially harmful, undeclared ingredients. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Both products contain either a thione analog of sildenafil, the active ingredient of Viagra, or a piperadino analog of vardenafil, the active ingredient in Levitra. Both Viagra and Levitra are FDA approved products for the treatment of ED. FDA has not approved True Man and Energy Max, therefore, the safety and effectiveness of these products are unknown. Consumers should discontinue use of these products and consult their healthcare professional about approved treatments for ED.
Read the complete 2007 Safety summary, including a link to the FDA News Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#TrueMan
May 10, 2007
FDA MedWatch Alert: OxyContin - Illegal Promotion By Manufacturer May Cause Health Risks For Consumers
FDA informed healthcare professionals of criminal charges and civil liabilities brought against Purdue Frederick in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces. The manufacturer's sales force was trained to make false claims about the product to healthcare professionals, thereby, misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications. These practices falsely promote the product and may cause health risks for consumers.
Read the complete 2007 Safety summary, including a link to the FDA Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContin
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