Health Advisories
CLICK HERE FOR IMPORTANT INFORMATION ABOUT INFLUENZA/H1N1.
TUESDAY, JUNE 1, 2010
FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Metronidazole, Ondansetron, and Ciprofloxacin Due To Potential Contamination
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals not to use certain intravenous bags of metronidazole, ondansetron, and ciprofloxacin because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Foreign matter should not be present in a sterile injectable product. Potentially affected products are sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.
Healthcare professionals should NOT use and should immediately remove from their pharmacy inventories any metronidazole, ondansetron, and ciprofloxacin intravenous bags sold under the following labels:
- Claris
- Sagent Pharmaceuticals
- Pfizer
- West–Ward Pharmaceuticals
Patients who have received these products should be observed for signs or symptoms of illness and treated appropriately.
Metronidazole and ciprofloxacin are antibiotics used to treat a variety of infections. Ondansetron is an antiemetic used to treat nausea and vomiting associated with chemotherapy or surgery.
A Claris customer received a complaint of white matter in a bag of metronidazole, and subsequent microbiological analysis identified the matter as a Cladosporium mold. Molds of this type can cause infections in susceptible patients, such as immunocompromised individuals. Another customer complaint of white matter in a bag of ondansetron was received, and that bag is currently under analysis. At this time, FDA is not aware of any reports of injuries due to administration of these products.
Claris is initiating a recall of all lots of these two products, as well as all lots of ciprofloxacin. These products were all manufactured on the same manufacturing line. FDA is investigating the situation and will notify the public when new information becomes available.
Only metronidazole, ciprofloxacin, and ondansetron in intravenous bags sold under the Claris, Sagent, Pfizer, and West-Ward Pharmaceuticals labels are affected.
TUESDAY, DECEMBER 15, 2009
CDC ANSWERS QUESTIONS REGARDING NON-SAFETY-RELATED VOLUNTARY RECALL OF CERTAIN LOTS OF SANOFI-AVENTIS PEDIATRIC H1N1 VACCINE: http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm
WEDNESDAY, OCTOBER 28, 2009
URGENT DRUG RECALL
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, lnc., Titusville, NJ, is notifying all US Direct Purchasers and Retail / lnstitutional Pharmacies of a voluntary recall of the product listed below. No other product marketed by
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, lnc. is impacted. This voluntary recall is being
conducted in coordination with the U.S. Food and Drug Administration.
INVEGA® (Paliperidone) 6 mg Extended-Release Tablets (30 count bottle)
Manufactured By: Janssen Cilag Manufacturing, LLC
Click here to read the recall notice from Janssen.
MONDAY, SEPTEMBER 14, 2009
Erythromycin Eye Ointment shortage and prevention of neonatal eye infections with GC and chlamydia
The recommended prophylaxis for ophthalmia neonatorum (ON), erythromycin (0.5%) ophthalmic ointment, has been identified as being in short supply by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
To prevent gonococcal ON, a prophylactic agent should be instilled into the eyes of all newborn infants and is required by North Carolina law. Currently, erythromycin ophthalmic ointment is the only recommended prophylactic agent available in the US. The primary recommendation for prophylaxis is to prevent gonococcal ophthalmia. Prophylaxis is also intended to prevent Chlamydia infection. Consideration for the variable efficacy of alternative agents in preventing chlamydial ophthalmia must be taken into consideration for follow-up.
CDC guidance addressing this shortage is available at http://www.cdc.gov/std/treatment/2006/erythromycinOintmentShortage.htm. There are links to this guidance and the Dear Colleague letter sent out by CDC on the CDC STD home page, http://www.cdc.gov/std/ and on the CDC Treatment home page, http://www.cdc.gov/std/treatment/
If one of the alternative treatments is employed due to erythromycin ophthalmic ointment shortage, NC DPH strongly encourages testing the mother for Chlamydia and gonorrhea at delivery, even if she has already been screened during the third trimester. Additionally, careful monitoring of infants for the development of symptoms should be performed after delivery and at the first postnatal office visit 48-72 hours post discharge from the hospital.
WEDNESDAY, AUGUST 26, 2009
H1N1 FLU VIRUS. See links below for important information about the 2009 H1N1 influenza virus:
Letter to public health professionals from Secretary Lanier M. Cansler
"What Do I Need to Know and Do?" informational flyer for the public in English
"What Do I Need to Know and Do?" informational flyer for the public in Spanish
or visit www.flu.nc.gov.
MONDAY, AUGUST 24, 2009
MONDAY, AUGUST 17, 2009
GlaxoSmithKline is recalling ADVAIR DISKUS® (fluticasone propionate/salmeterol inhalation powder) 100/50 mcg packaged as 60 doses for lot number 92P7632 from the retail and wholesale levels. This lot is being recalled due to a low level defect that may result in the patient not receiving the medication as they advance doses through the Diskus unit.
Click here to read this urgent recall notice from GlaxoSmithKline.
MONDAY, JUNE 15, 2009
URGENT NEWS ALERT FROM NABP & FDA. Stolen Insulin Vials Resurface in US Market: Stolen vials of the long-acting insulin Levemir® made by Novo Nordisk Inc have reappeared and are being sold in the United States market, Food and Drug Administration (FDA) reported on June 13, 2009. These stolen insulin vials may not have been stored and handled properly and may be dangerous
for patients to use.
Three lots of 10 ml vials (a total of 129,000 vials) of the product, insulin detemir (rDNA origin) injection, were originally reported stolen in North Carolina and are identifiable by the following lot numbers:
- XZF0036
- XZF0037
- XZF0038
Click here for more information, including a link to the June 13 FDA news release.
MONDAY, JUNE 29, 2009
Alert from U.S. Food and Drug Administration
RE: Astellas Prescription Drug Products
Astellas recently announced the market withdrawal of specific lots of certain Astellas prescription drug products because a transport trailer containing these products was stolen on June 17, 2009. FDA is committed to protecting the public from receiving stolen drug products that may not have been stored and handled properly and may be dangerous for patients to use.
In support of this mission, FDA is requesting assistance from pharmaceutical drug distributors and pharmacies which may have received unsolicited or suspicious offers for Astellas drug products that were stolen on June 17, 2009 (see link to Astellas press release below). If you received any suspicious or unsolicited offers for these drugs after the date of the theft or think that you may have been sold stolen product, FDA is asking your help in reporting this information to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI web site: http://www.fda.gov/ICECI/CriminalInvestigations/ucm123025.htm.
More information about the market withdrawal is available at the Astellas website at the following link:
MONDAY, APRIL 27, 2009
Theft of Copaxone Reported; Pharmacists Should Be Alert for Receipt of Any Product From Affected Batch/Lot Number #P53159. Click here for more information (memo from National Association of Boards of Pharmacy).
FRIDAY, APRIL 24, 2009
THURSDAY, JANUARY 15, 2009
CDC Health Advisory: CDC Issues Interim Recommendations for the Use of Influenza Antiviral Medications in the Setting of Oseltamivir Resistance among Circulating Influenza A (H1N1) Viruses, 2008-09 Influenza Season. Click here to read the advisory and accompanying antiviral guidance table.
MONDAY, JANUARY 12, 2009
PriCara® voluntarily recalls several lot #s of Ultram®ER (tramadol HCL) Extended Release Tablets 100mg (manufactured by Biovail Corporation). Read the December 29, 2009 recall notice here.
MONDAY, JANUARY 5, 2009
PriCara® voluntarily recalls Lot # 0817239 of Duragesic® 50 mcg/h (Fentanyl Transdermal System) CII. Read the December 29, 2008 recall notice here.
MONDAY, JANUARY 5, 2009
Greenstone LLC voluntarily recalls Lot # 6HP033A of Azithromycin 500mg Tablets. Read the December 29, 2008 recall notice here.
TUESDAY, AUGUST 12, 2008
VOLUNTARY RECALL NOTICE - Ortho Biotech Products, L.P. is voluntarily recalling one manufactured lot of PROCRIT® (epoetin alfa). Click here to read the notice.
TUESDAY, JUNE 17, 2008
FDA announces a Public Health Advisory to alert patients and their care providers about the need to switch from chlorofluorocarbon (CFC) to hydrofluoroalkane (HFA) metered-dose inhalers (MDIs) and to educate patients about the proper care of the alternative products.
Tell patients switching to HFA inhalers that the new products contain the same medication as CFC inhalers but need more care because they do not use the same propellants. The HFA actuator must be cleaned under warm running water once a week; if it is not kept clean, it can become clogged and the albuterol will not be delivered. The devices also need to be “primed” before initial use. Inform patients that each time they receive a new HFA inhaler, they should press down at least 3 to 4 times to prime the device. CFC inhalers did not need to be cleaned because CFC is itself a cleaning agent. Reassure patients of the drug’s effectiveness, even though the spray may taste different or not feel as strong as that from a CFC inhaler.
Please visit http://www.pharmacist.com/AM/Template.cfm?Template=/CM/ContentDisplay.cfm&ContentID=16419 for more information from APhA
and http://www.fda.gov/cder/drug/advisory/albuterol_cfc.htm for the FDA notice.
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
Copyright © 2006 North Carolina Board of Pharmacy
site design IV Design