FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes

FDA NEWS RELEASE For Immediate Release: Oct. 18, 2012 Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes On Oct. 17, the U.S. Food and Drug More »

FDA approves Fycompa to treat seizures

FDA NEWS RELEASE For Immediate Release: Oct. 22, 2012 Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA approves Fycompa to treat seizures The U.S. Food and Drug Administration today approved Fycompa (perampanel) tablets to More »

FDA approves Synribo for chronic myelogenous leukemia

FDA NEWS RELEASE For Immediate Release: Oct. 26, 2012 Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA approves Synribo for chronic myelogenous leukemia The U.S. Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) More »

 
eye

FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes

FDA NEWS RELEASE

For Immediate Release: Oct. 18, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes

On Oct. 17, the U.S. Food and Drug Administration approved Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).

VMA can contribute to eye problems if the vitreous (jelly in the center of the eye) starts to move away from the macula (a part of the retina responsible for reading vision). This movement can lead to damage of the macula due to pulling or tugging on the macula.

Jetrea is an enzyme that breaks down proteins in the eye responsible for VMA. The breakdown of these proteins allows a better separation between the vitreous and macula and can reduce the chances that tugging will occur. The alternative treatment for this condition is a surgical procedure called a vitrectomy.

“Today’s approval represents a significant advancement in treatment for patients with symptomatic VMA,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “Those with this sight-threatening disease now have a non-surgical treatment option.”

The safety and effectiveness of Jetrea were established in two clinical studies involving 652 patients with symptomatic VMA. Patients were randomly assigned to receive a single injection of Jetrea into the eye or a substance without the active ingredient.

Patients were evaluated over the next 28 days and for any side effects over the next six months. The studies found that VMA resolved in 26 percent of patients treated with Jetrea compared with 10 percent of those treated with the inactive product.

The most common side effects reported in patients treated with Jetrea include eye floaters; bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; flashes of light (photopsia); blurred vision; unclear vision; vision loss; retinal edema (swelling); and macular edema.

Jetrea is manufactured by Iselin, N.J.-based ThromboGenics Inc.

For more information:

FDA Approved Drugs: Questions and Answers

FDA: Drug Innovation

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Safety Communication: Neptune 1 Silver Waste Management System and Neptune 2 Ultra Waste Management System

FDA Safety Communication: Neptune 1 Silver Waste Management System and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra)

Date Issued: October 05, 2012

Audience:

  • Surgeons, anesthesiologists, operating room nurses and technologists, surgical technicians
  • Hospital and/or facility administrators, surgical directors, ambulatory surgery centers, risk managers, chief nurse executives, purchasing departments

Product:

  • Neptune 1 Silver Waste Management System (Neptune 1 Silver)
  • Neptune 2 Ultra Waste Management System Device (Neptune 2 Ultra)

The Neptune 2 Ultra was manufactured from February 2001 through April 2012 and distributed from March 26, 2001 through Aug. 7, 2012. Stryker no longer manufacturers the Neptune Silver; however, they still maintain and support the device.

The Neptune 1 Silver Waste Management System (Neptune 1 Silver) and the Neptune 2 Ultra Waste Management System (Neptune 2 Ultra), manufactured by Stryker Instruments, are intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities. The Neptune 2 Ultra can also remove smoke generated at surgical sites by electrocautery or laser devices. Both systems consist of a mobile rover unit that can be relocated to a waste disposal area so the waste collection canisters can be emptied through the device’s docking station.

(While Stryker recalled three additional Neptune systems — the Neptune 1 Gold Waste Management System, the Neptune Gold International Waste Management System and the Neptune 1 Bronze Waste Management System — in August 2012, this safety communication does NOT apply to them.)

Purpose:

To alert health care providers NOT to use the Neptune 1 Silver Waste Management System or the Neptune 2 Ultra Waste Management System unless there is no alternative suction device or waste management system available. Facilities should evaluate the risks and benefits of using the Neptune 1 Silver or the Neptune 2 Ultra; if they decide to continue using the device, they must file a Certificate of Medical Necessity with Stryker by Oct. 12, 2012 in order to continue to receive supplies and customer support for this device.

Summary of Problem and Scope:

The FDA and Stryker received one report of serious injury and one report of death as a result of tissue damage resulting from use of the Neptune 2 Ultra Waste Management System.

The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied, and that the instructions for use on the device did not specifically warn against this action. When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.

Stryker issued issued a recall for these and two other models of its Neptune system (http://www.fda.gov/Safety/Recalls/ucm320958.htm), and issued revised instructions for use that addressed this warning.

While labeling modifications were sufficient for some of the Neptune models, the FDA determined that the Neptune 2 Ultra Waste Management System and the Neptune 1 Silver Waste Management System contained other modifications compared to prior models that were significant enough to have warranted the submission of a new premarket notification (510(k)) by Stryker for review by the FDA.

However, the FDA has not cleared the Neptune 2 Ultra Waste Management System or the Neptune 1 Silver Waste Management System for marketing. On Sept. 18, 2012, Stryker mailed an updated recall notice disclaimer icon  to all their customers and advised them of this issue and the steps it would take to respond to the FDA’s concerns about the safety of the device and the company’s failure to obtain FDA clearance for modifications to the original device.

The FDA is not currently asking Stryker to remove the Neptune 2 Ultra Waste Management System and the Neptune 1 Silver Waste Management System from the U.S. market due to concerns that removal would likely create immediate market shortages.

Facilities without alternatives to these two devices should carefully evaluate the risks and benefits associated with their continued use and submit a Certificate of Medical Necessity disclaimer icon to Stryker prior to Oct. 12, 2012 in order to obtain assistance in its continued use and follow the recommendations outlined below.

Recommendations for Health Care Providers:

The FDA and Stryker recommend that facilities with an acceptable alternative to the Neptune 1 Silver and/or Neptune 2 Ultra should transition to that alternative as soon as possible.

If your facility does not have an alternative means for surgical waste disposal during surgery, the FDA advises you to evaluate the risks and benefits before you use this device, then complete and send the required Certificate of Medical Necessity to Stryker. Health care facilities should then ensure that users of these devices follow the recommendations listed below to mitigate the risks of using these devices:

  • Ensure all users of these devices are retrained on the proper use of the Neptune 1 Silver and Neptune 2 Ultra devices and are fully aware of the applications for which they are intended to be used and the risks of using them improperly.
  • Alwaysconsider the type of tissue associated with the surgical procedure before using this system and adjust suction levels accordingly. Use of inappropriately high level of suction may result in severe injury or death.
  • Ensure that you have each vacuum attached to the correct port because all vacuum ports appear identical making it more difficult to know which port corresponds with the appropriate level of suction.
  • Verify that you are using the intended units of measure when setting suction levels to avoid operating the devices at a higher or lower level of suction than you expect and/or need for a specific clinical application. This device uses multiple units of measurement that could be confused leading to errors in suction levels: inches of mercury (in-Hg); millimeters of mercury (mm-Hg), kilopascals (kPa)
    • For example the digital readout may read 21 in-Hg which would be equivalent to 530 mm-Hg.
  • Ensure you understand the adjustable vacuum limits and maximum limit for each device:
    • The Neptune 1 Silver vacuum limit is adjustable from 254 – 483 mm-Hg or 11.0 – 19.0 in-Hg and has a maximum vacuum level of 483 mm-Hg or 19.0 in-Hg
    • The Neptune 2 Ultra vacuum limit is adjustable from 50 – 530 mm-Hg, 2.0 – 21.0 in-Hg, or 7.0 – 71.0 kPa. and has a maximum vacuum level of 530 mm-Hg, 21.0 in-Hg, or 71.0 kPa.
  • Do NOT apply high flow suction or allow extended exposure of suction to tissue associated with procedures that require no suction, low vacuum or low flow suction.
  • Do NOT use the Neptune 1 Silver in low suction applications that require vacuum levels below 254 mm-Hg or 10.0 in-Hg as this could result in injury to vital anatomical structures, and/or hemorrhage, both of which may result in serious injury and/or death.
  • Do NOT use the Neptune 2 Ultra in low suction applications that require vacuum levels below 50 mm-Hg, 2.0 in-Hg, or 7.0 kPa as this could result in injury to vital anatomical structures and/or hemorrhage, both of which may result in serious injury and/or death.
  • Do NOT use these devices for respiratory tract suction.
  • Do NOT use these devices to provide suction to other suction powered accessories such as Pleur Evac devices.

If you plan to continue using the Neptune 1 Silver and/or the Neptune 2 Ultra devices, you must complete theCertificate of Medical Necessity disclaimer icon and send it back to Stryker Instruments atstrykerinstrumentsrecalls@stryker.com or fax 866-521-2762 by Oct. 12, 2012. If a Certificate of Medical Necessity is not received by this date, Stryker will not be able to provide any disposable accessories, replacement parts or provide service for your device(s). All facilities that complete the Certificate of Need for the Neptune 1 Silver and Neptune 2 Ultra will receive warning labels to apply to the device.

Customers with questions should contact Stryker Instruments at 269-389-2316 or strykerinstrumentsrecalls@stryker.com for more information.

FDA Activities :

  • On August 15, 2012, the FDA issued a Class I recall of the Neptune 1 Bronze, Neptune 1 Silver, Neptune 1 Gold, Neptune Gold International and Neptune 2 Ultra Waste Management Systems, the most serious type of recall. This recall included the following revised Instruction for Use Warning: Do Not apply High Flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low vacuum or low flow suction. All Neptune 1 Bronze, Neptune 1 Gold and Neptune 1 Gold International customers should have received warning labels to apply to the device in an updated notice mailed to customers on Sept. 25, 2012.
  • Only customers that complete the Certificate of Medical Necessity can use and will receive warning labels for the Neptune 1 Silver and Neptune 2 Ultra devices.
  • Stryker voluntarily stopped selling the Neptune 2 Ultra as of Aug. 7, 2012 and they have informed the FDA that they plan to seek clearance for the currently uncleared devices. They no longer manufacturer to Neptune 1 Silver.
  • The FDA will continue to monitor this issue and keep the public informed if new information becomes available.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the Neptune 1 Silver and/or Neptune 2 Waste Management Systems, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

To help us learn as much as possible about the adverse events associated with Fluid Waste Management Systems, please include the following information in your reports, if available:

  • Product Name
  • Lot Number
  • Manufacturer
  • Relevant events prior and subsequent to the referenced problem
  • Concomitant medical products
  • Details of the adverse event and medical intervention (if required)

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

Fycompa

FDA approves Fycompa to treat seizures

FDA NEWS RELEASE

For Immediate Release: Oct. 22, 2012
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Fycompa to treat seizures

The U.S. Food and Drug Administration today approved Fycompa (perampanel) tablets to treat partial onset seizures in patients with epilepsy ages 12 years and older.

Partial seizures are the most common type of seizure seen in people with epilepsy. Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. Seizures cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, and generalized convulsions with loss of consciousness.

“Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available for patients with epilepsy.”

Results from three clinical trials showed improvement in seizure control in patients taking Fycompa compared with those taking an inactive pill (placebo).

The most common adverse reactions reported by patients receiving Fycompa in clinical trials include: dizziness, drowsiness, fatigue, irritability, falls, upper respiratory tract infection, weight increase, vertigo, loss of muscle coordination (ataxia), gait disturbance, balance disorder, anxiety, blurred vision, stuttering (dysarthria), weakness (asthenia), aggression, and excessive sleep (hypersomnia).

Fycompa’s label has a boxed warning to alert prescribers and patients about the risk of serious neuropsychiatric events, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes. Some of these events were reported as serious and life-threatening. Violent thoughts or threatening behavior was also observed in a few patients. Patients and caregivers should alert a health care professional immediately if changes in mood or behavior that are not typical for the patient are observed. Health care professionals should closely monitor patients during the titration period when higher doses are used.

Fycompa will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.

Fycompa is manufactured by Eisai Inc. of Woodcliff Lake, N.J.
For more information:
National Institute of Neurological Disorders and Stroke, Epilepsy Information Page
Innovation in Development of Drugs and Biological Products

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Update on Fungal Meningitis

FDA provides NECC Customer List

[10-22-2012] On October 4, 2012, FDA advised medical professionals that all products produced by New England Compounding Center (NECC) should be retained, secured, and withheld from use. On October 6, NECC announced a voluntary recall of all its products currently in circulation that were compounded at and distributed from its Framingham, Massachusetts facility. A complete list of all NECC products subject to this recall can be accessed here   [HTML | PDF].  On October 15, 2012, FDA further advised healthcare providers to follow-up with patients who were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.

Today, FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England Compounding Center’s Framingham, MA facility. The first list includes customer names and addresses, organized by state.  The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped, and the shipping date.  The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists.  Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.

FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:

  • The medication was an injectable product purchased from or produced by NECCincluding an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
  • The medication was shipped by NECC on or after May 21, 2012, and
  • The medication was administered to patients on or after May 21, 2012.

Since the May 21, 2012 date is the date the first of three lots of methylprednisolone acetate implicated in the current outbreak was produced, products produced and shipped by NECC on or after May 21, 2012 are believed at this time to be of greatest risk of contamination.  Now that we have shipping information available, we are updating FDA’s recommendation to health care providers so that they can focus their attention on following up with the patients who are believed to be at greatest risk of receiving a contaminated product.

Advice to NECC Customers

Customers identified on these lists should check their stocks to identify whether they have any products from the New England Compounding Center (NECC), and they should immediately isolate any identified product from their drug supplies.  All NECC products are subject to voluntary recall.  Customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.

Advice to Patients

Patients who believe they received an injection or other product that was shippedby NECC on or after May 21, 2012 should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned.  The meningitis outbreak has occurred in patients who received injections near the spine (back or neck).  The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status.  Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis.  Other possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest).  Patients should contact their healthcare provider if they have any of these signs or symptoms.

Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date.  FDA is not recommending these patients follow-up with their healthcare providers unless they are experiencing symptoms of infection.

Advice to Healthcare Professionals

FDA advises healthcare professionals to follow-up with patients who have been administered an injectable product shipped by NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution.  FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories, or for patients who may have received an NECC product in these categories before May 21, 2012.  Patients who received an NECC product prior to May 21, 2012 and who have not experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date.  FDA is not recommending that healthcare providers follow-up with these patients unless they have reported symptoms of infection.

Health care professionals should retain and secure all remaining products purchased from NECC.  All NECC products are subject to voluntary recall.  Clinics or customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain instructions on how to return products to NECC.

Clinicians and patients are also requested to report any suspected adverse events following use of these products to FDA’s MedWatch program at 1-800-332-1088or www.fda.gov/medwatch.

Healthcare professionals and patients may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.

If you have identified NECC customers who received product that do not appear on these lists, please contact FDA’s Drug Information Line to report this problem.

FDA continues its investigation and may issue additional public communications as appropriate.

synribo

FDA approves Synribo for chronic myelogenous leukemia

FDA NEWS RELEASE

For Immediate Release: Oct. 26, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Synribo for chronic myelogenous leukemia

The U.S. Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.

An estimated 5,430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo is intended to be used in patients whose cancer progressed after treatment with at least two drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML.

Synribo blocks certain proteins that promote the development of cancerous cells. It is injected just under the skin (subcutaneously) twice daily for 14 consecutive days over a 28-day cycle until white blood cell counts normalize (hematologic response). Synribo is then administered twice daily for seven consecutive days over a 28-day cycle as long as patients continue to clinically benefit from therapy.

“Today’s approval provides a new treatment option for patients who are resistant to or cannot tolerate other FDA-approved drugs for chronic or accelerated phases of CML,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Synribo is the second drug approved to treat CML in the past two months.”

On Sept. 4, 2012, the FDA approved Bosulif (bosutinib) to treat patients with chronic, accelerated or blast phase Philadelphia chromosome positive CML who are resistant to or who cannot tolerate other therapies.

Synribo is approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts additional clinical studies to confirm the drug’s clinical benefit and safe use. Synribo also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.

The effectiveness of Synribo was evaluated using a combined cohort of patients whose cancer progressed after previous treatment with two or more TKIs. All participants were treated with Synribo.

The drug’s effectiveness in chronic phase CML was demonstrated by a reduction in the percentage of cells expressing the Philadelphia chromosome genetic mutation found in most CML patients. Fourteen out of 76 patients (18.4 percent) achieved a reduction in an average time of 3.5 months. The median length of the reduction was 12.5 months.

In accelerated phase CML, Synribo’s effectiveness was determined by the number of patients who experienced a normalization of white blood cell counts or had no evidence of leukemia (major hematologic response, or MaHR). Results showed five out of 35 patients (14.3 percent) achieved MaHR in an average time of 2.3 months. The median duration of MaHR in these patients was 4.7 months.

The most common side effects reported during clinical studies include a low level of platelets in the blood (thrombocytopenia), low red blood cell count (anemia), a decrease in infection-fighting white blood cells (neutropenia) which may lead to infection and fever (febrile neutropenia), diarrhea, nausea, weakness and fatigue, injection site reaction, and a decrease in the number of lymphocytes in the blood (lymphopenia).

Synribo is marketed by Frazer, Pa.-based Teva Pharmaceuticals. Bosulif is marketed by New York City-based Pfizer.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.