The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm302285.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Aceon (Perindopril Erbumine)

Altace (Ramipril)

Atacand (Candesartan Cilexetil)

Sporanox (Itraconazole)

Zortress (Everolimus)

Advicor (Niacin Extended-release/Lovastatin)

Altoprev (Lovastatin Extended-release)

Amturnide (Aliskiren, Amlodipine and Hydrochlorothiazide)

Premarin (Conjugated Estrogens,USP)

Tekamlo (Aliskiren and Amlodipine)

Tekturna (Aliskiren)

Tekturna HCT (Aliskiren and Hydrochlorothiazide)

Vagifem (Estradiol)

Valturna (Aliskiren and Valsartan)

Viracept (nelfinavir mesylate)

Beyaz (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)

Cimzia (Certolizumab Pegol) 

Krystexxa (Pegloticase)

Levaquin (Levofloxacin) 

Levemir (Insulin Detemir [rDNA origin])

Neupro (Rotigotine)

Nutropin (Somatropin [rDNA origin])

Prandimet (Repaglinide and Metformin HCL)

Safyral (Drospirenone and Ethinyl Estradiol and Levomefolate Calcium)

Sutent (Sunitinib Malate)

Synagis (palivizumab)

Tarceva (Erlotinib)

Victoza (liraglutide [rDNA])

Votrient (Pazopanib)

Xgeva (Denosumab)

Yasmin (Drospirenone and Ethinyl Estradiol)

Yaz (Drospirinenone and Ethinyl Estradiol)

Zegerid (Omeprazole and Sodium Bicarbonate) 

Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall – May Contain More Than the Intended Fill Volume

AUDIENCE: Risk Manager, Consumer

ISSUE: Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

The affected lot number is 07547LL, with an expiration date of July 1, 2013. The affected lot was distributed in September – October 2011. It was initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.

BACKGROUND: The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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 form or 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

Read the MeDWatch safety alert, including a link to the updated Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304044.htm

Franck’s Compounding Pharmacy – Ongoing Investigation of Fungal Endophthalmitis Cases: CDC Recommendations

 [UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation. Franck’s Lab has recalled one additional lot of triamcinolone acetonide P.F. 80mg/ml. The recall involved four physicians and five prescriptions.

 [UPDATED 04/20/2012] FDA issues second warning to physicians regarding cvertain compounded drugs from Franck’s. FDA received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.

[Posted 03/19/2012]

AUDIENCE: Ophthalmology, Risk Manager

ISSUE: FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG), supplied by Franck’s Pharmacy, during eye surgeries. Clinicians in several states reported the adverse events. FDA, along with CDC and local and state public health agencies, are actively investigating these adverse events.

BACKGROUND: The BBG was supplied by Franck’s Compounding Lab, Ocala, Florida. Franck’s Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter (link below). Brilliant Blue G is not an approved drug in the U.S. 

RECOMMENDATION: Immediately quarantine and return any remaining Brilliant Blue G product from Franck’s Compounding Lab. This includes all lots of Brilliant Blue G received from Franck’s.

FDA requests that practitioners report to MedWatch any cases of endophthalmitis, fungal or bacterial, that occurred within the last six months, associated with eye surgery in which Brilliant Blue G from any source was used.

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 form or 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-0178Read the

MedWatch safety alert, including a link to the Press Release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm296383.htm

Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication – Drug Interactions

[UPDATED 04/26/2012]

FDA notified healthcare professionals that the Victrelis drug label has been revised to state that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended. The findings of a drug-drug interaction study and clinical trial showed that co-administration increased of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir).

[Posted 02/09/2012]

AUDIENCE: Infectious Disease, Pharmacy

ISSUE: FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.

A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with Kaletra (lopinavir/ritonavir) reduced the blood levels of the HIV medicines and boceprevir in the body (see Data Summary below). FDA will be updating the Victrelis drug label to include information about these drug interactions. 

BACKGROUND: Victrelis is a hepatitis C virus (HCV) protease inhibitor used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults. HIV protease inhibitors are a class of anti-viral drugs used to treat HIV infection. Ritonavir is an HIV protease inhibitor used to “boost” other HIV protease inhibitors, increasing their levels in the blood and making them more effective.

RECOMMENDATION: Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on Victrelis and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound. 

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 form  or 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

Read the MedWatch safety alert, including a link to the Drug Safety Communication at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291144.htm

Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result

AUDIENCE: Cardiology, Laboratory

ISSUE: With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results may cause serious adverse health consequences, including death. The affected lot numbers are 163176 and 163177.

BACKGROUND: Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays are used to determine heart damage as an aid in the diagnosis of a heart attack.  

RECOMMENDATION: On March 12, 2012, Roche Diagnostics Operations sent an “URGENT MEDICAL DEVICE REMOVAL” letter to all its customers who received the affected lots of Elecsys Troponin I or Elecsys Troponin I STAT.  The letter described the product, problem, and actions to be taken.  Customers were instructed to immediately discontinue use of the affected products.

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 form or 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

Read the MedWatch safety alert, including a link to the Recall Notice at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301483.htm

Certain Compounded Drugs from Franck’s: FDA Issues Second Warning to Physicians

• Brilliant Blue G (BBG)
• Triamcinolone

AUDIENCE: Eye Care, Family Practice, Pharmacy

ISSUE: FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012. The agency has also recently received reports of eye infections in patients who were given injections of drug products containing triamcinolone during eye surgery.

BACKGROUND: Clinicians in several states reported the adverse events. FDA, CDC, and local and state public health agencies are actively investigating these incidents.

These drugs were supplied by Franck’s Pharmacy in Ocala, Florida. Brilliant Blue G is not an approved drug in the United States. Franck’s has recalled all lots of BBG and one lot of Triamcinolone Acetonide P.F

RECOMMENDATION: The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to stop use of all sterile triamcinolone-containing products purchased from Franck’s until further information regarding the safety of these products is available.

FDA requests that practitioners report to FDA any cases of suspected fungal or bacterial infections, which have occurred within the last six months, associated with drugs labeled as sterile from Franck’s Pharmacy:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or 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

Read the MedWatch safey alert, including a link to the Updated FDA Warning, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301137.htm

Aliskiren-containing Medications: Drug Safety Comunication – New Warning and Contraindication

including:

• Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
• Tekturna (aliskiren hemifumarate)
• Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
• Tekamlo (aliskiren hemifumarate and amlodipine besylate)
• Valturna (aliskiren hemifumarate and valsartan). Valturna will no longer be marketed after July 2012

AUDIENCE: Internal Medicine, Pharmacy, Endocrinology

ISSUE: FDA notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min). The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”

BACKGROUND: Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.

RECOMMENDATION: Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia. Avoid use of aliskiren with ARBs or ACEIs in patients with renal impairment where GFR < 60 mL/min. Patients should not stop taking aliskiren without talking to your healthcare professional. Stopping aliskiren suddenly can cause problems if your high blood pressure (hypertension) is not treated.

See the Drug Safety Communication for the Data Summary, a list of ACEI and ARB products, and additional recommendations for healthcare professionals and patients.

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 form or 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

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301120.htm

Other‐Sonic Generic Ultrasound Transmission Gel: Safety Communication – Risk of Bacterial Contamination

AUDIENCE: Risk Manager, OB/GYN, Radiology, Infectious Disease

ISSUE: FDA notified health care professionals and facilities to STOP using Other‐Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, because of bacterial contamination with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca. The contamination was found in lot numbers 060111, 090111, and 120111. These lots are sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers.

Pseudomonas aeruginosa is found most often in water and soil. Patients exposed to the bacteria on the surface of their skin could develop inflammatory dermatitis, even on intact skin. Klebsiella bacteria is often found in the digestive tract where they do not often cause infection; however, when the lungs or other tissues are exposed to Klebsiella bacteria, either minor problems or more serious infections, such as pneumonia, wound infection, or bloodstream infections, could occur.

BACKGROUND: Other‐Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc. is a non‐sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.

RECOMMENDATION: Do NOT use Other‐Sonic Generic Ultrasound Transmission Gel from lot numbers 060111 through 120111. Identify patients who have been exposed to these lots of Other‐Sonic Generic Ultrasound Transmission Gel. Review the procedures they underwent and the outcomes of those procedures. Then, determine if further evaluation is needed. See the FDA Safety Communication for additional information.

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 form or 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

To help us learn as much as possible about the adverse events associated with Other‐Sonic Generic Ultrasound Transmission Gel, please include the following information in your reports, if available:

1. Lot number
2. Bottle size
3. Date of adverse event
4. Type of ultrasound procedure
5. Details of the adverse event and medical intervention (if required)

 Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm

Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall – May Contain More Than Intended Fill Volume

AUDIENCE: Risk Manager, Pain Management

ISSUE: Customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume. Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

BACKGROUND: The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 10830LL, with an expiration date of April 1, 2013. Morphine Sulfate Carpujects 4 mg/mL are packaged in Slim-Pak tamper detection packages with each box containing 10 Carpujects (NDC 0409-1258-30). 

The affected lot was distributed in January 2012. It was initially distributed to wholesalers and a limited number of hospitals in Arizona, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas and Virginia. 

RECOMMENDATION: Anyone with an existing inventory of affected product should stop use and distribution and quarantine the product immediately and call Stericycle at 1-888-912-7088 to arrange for the return of the product.

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 form or 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

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300852.htm

The MedWatch March 2012 Safety Labeling Changes posting includes 39 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm299284.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Atacand HCT (candesartan cilextetil/hydrochlorothiazide)
Benicar (olmesartan medoxomil)
Sporanox (itraconazole)
Twynsta (telmisartan/amlodipine)
Zestoretic (lisinopril/hydrochlorothiazide)
Zestril (lisinopril)
Benlysta (belimumab)
Celexa (citalopram hydrobromide)
Enablex (darifenacin)
Incivek (telaprevir)
Janumet (sitagliptin and metformin fixed-dose combination)
Januvia (sitagliptin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Lidocaine in 5% Dextrose Injection
Magnevist (brand of gadopentetate dimeglumine)
Revlimid (lenalidomide)
Reyataz (atazanavir sulfate)
Treximet (sumatriptan and naproxen sodium)
Votrient (pazopanib)
Zometa (zoledronic acid)
Zmax (azithromycin extended release)