Category Archives: Prescription News

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.

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.