Product News

Product News

New Combination Oral Contraceptive
The US Food and Drug Administration (FDA) has approved Natazia, a combination hormonal tablet for use as an oral contraceptive. Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United States. Four-phasic refers to the doses of progestin and estrogen varying at 4 times throughout each 28-day treatment cycle. The product is manufactured by Bayer HealthCare Pharmaceuticals.
The safety and efficacy of Natazia as an oral contraceptive was evaluated in two multicenter phase 3 clinical trials in North America and Europe. The trials involved 1867 women and nearly 30,000 28-day treatment cycles. Natazia was found to be effective as a hormonal contraceptive in both studies.

Immunotherapy Cleared for Prostate Cancer
Sipuleucel-T (Provenge), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease, has been approved by the FDA. The treatment is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment. Sipuleucel-T is manufactured by Seattle-based Dendreon Corp.

Sipuleucel-T is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of sipuleucel-T is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. sipuleucel-T is administered intravenously in a 3-dose schedule given at about 2-week intervals.

The effectiveness of sipuleucel-T was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving sipuleucel-T treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Device for Asthma
The first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults has been approved by the FDA. The Alair Bronchial Thermoplasty System is intended for patients ages ≥18 years whose severe and persistent asthma is not well controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient’s ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system. The agency is requiring a 5-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx Inc, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.

New OxyContin Formulation
The FDA has approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication. The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication. The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; it still can be abused or misused by simply ingesting larger doses than are recommended.

OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require a continuous, around-the-clock opioid analgesic for management of their moderate to severe pain for an extended period of time. Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often. However, people intent on abusing the previous formulation have been able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of OxyContin abuse.

The manufacturer of OxyContin, Purdue Pharma LP, will be required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of this opioid. The FDA is also requiring a Risk Evaluation and Mitigation Strategy that will include the issuance of a Medication Guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain.

Third Pancreatic Enzyme Approved
The FDA has approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval. Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.

Until the approval, Creon, manufactured by Abbott Products, Inc. (formerly Solvay Pharmaceuticals), and Zenpep, manufactured by Eurand Pharmaceuticals, were the only FDA-approved pancreatic enzyme products on the market.

Approval of Pancreaze, manufactured by Johnson & Johnson, increases the supply of FDA-approved PEPs for the estimated 200,000 or more patients in the United States who need these products. Approved pancreatic enzyme products meet FDA standards for safety, efficacy, and product quality.
Unapproved versions of pancreatic enzyme products have been available for many years. In October 2007, the FDA established a date of April 28, 2010, for the makers of unapproved pancreatic enzyme products to stop manufacturing and distributing unapproved products. Supplies of approved PEPs are expected to meet demand.

Currently, the FDA is working with approved PEPs manufacturers, patient advocacy groups, and health care professional organizations to make the public aware of the availability of pancreatic enzyme products. Patients with questions about their current PEP or making a switch to a different pancreatic enzyme product should consult with their healthcare provider.

Generics for Hypertension
The first generic versions of two drugs used for the treatment of hypertension have been approved by the FDA. Losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets (a combination drug) are the generic equivalents of Cozaar and Hyzaar tablets, respectively.

Cozaar and Hyzaar tablets are widely used antihypertensive drugs. Both generic losartan products will carry the same safety warnings as their brand counterparts. These warnings include a boxed warning against the use of these products during the second and third trimesters of pregnancy.

Losartan potassium tablets are approved in 25-mg, 50-mg, and 100-mg strengths, and losartan potassium and hydrochlorothiazide tablets are approved in 50-mg/12.5-mg, 100-mg/12.5-mg, and 100-mg/25-mg strengths. Both products are manufactured by TEVA Pharmaceuticals USA.
In related actions, the FDA also approved applications from several other companies for losartan potassium and hydrochlorothiazide tablets for the 100-mg/12.5-mg strength only. These companies include Mylan Pharmaceuticals Inc, Roxane Laboratories Inc, and Torrent Pharmaceuticals Ltd.

Safety Review

Prostate Cancer Meds Under Review
The FDA is conducting a safety review of commonly used prostate cancer drugs after a preliminary review suggested an increase in the risk of diabetes and certain cardiovascular diseases in men treated with gonadotropin-releasing hormone (GnRH) agonists. GnRH agonists, a class of medications primarily used to treat men with prostate cancer, have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death in men treated with one of the medications, according to a preliminary and ongoing analysis of several studies by the FDA.

Based on initial findings, the FDA advises healthcare professionals to be aware of these potential risks and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer. Patients receiving a GnRH agonist should be monitored for the development of diabetes and cardiovascular disease, and cardiovascular risk factors such as smoking and increases in blood pressure, cholesterol, blood sugar, and weight should be managed according to current clinical practice. The FDA said that patients should not stop treatment with a GnRH agonist unless instructed to do so by a healthcare professional.

At this time, FDA has not made any conclusions about whether GnRH agonists cause an increase in the risk of diabetes and heart disease in patients receiving one of these medications to treat prostate cancer. Medications in the GnRH class are marketed under the brand names Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex. There are also several generic products available.

GnRH agonists are drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer. Some GnRH agonists are also used in women to help manage the pain caused by endometriosis, to improve anemia associated with uterine fibroids prior to hysterectomy and in some cases for palliative treatment of advanced breast cancer. Some GnRH agonists are also used in children to treat central precocious puberty. There are no known studies that have evaluated the risk of diabetes and heart disease in children taking GnRH agonists.

Eligard is marketed by Sanofi-Aventis. Lupron is marketed by Abbott Laboratories. Synarel is marketed by Pfizer. Trelstar is marketed by Watson Pharmaceuticals. Vantas is marketed by Endo Pharmaceuticals. Viadur is marketed by Bayer Pharmaceuticals. Zoladex is marketed by AstraZeneca.

Warning

Defibrillators May Malfunction
About 280,000 external defibrillators used worldwide in healthcare facilities, public places, or in the home may malfunction during attempts to rescue people in sudden cardiac arrest, according to an FDA warning. External defibrillators can send an electric shock to the heart to try to restore normal heart rhythm when sudden cardiac arrest occurs.

Faulty components in defibrillators manufactured by Cardiac Science Corp may cause the devices to fail to properly deliver a shock. In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.

The 14 models, which include automated and semi-automated devices, are:
• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
• CardioVive models 92531, 92532 and 92533
• Nihon Kohden models 9200G and 9231 and
• GE Responder models 2019198 and 2023440.

The FDA recommends that hospitals, nursing homes and other high-risk settings obtain alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators.
For all other users, including those who use the device at home or as part of public access programs, the FDA recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.

If alternative external defibrillators are not immediately available, then FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy. The potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.

Recall

Infusion Pumps Recalled
The FDA sent a letter to Baxter Healthcare Corp on April 30 ordering the company to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use in the United States. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use.
Additionally, the FDA is ordering the company to provide refunds to customers or replace pumps at no cost to customers help defray the cost of replacement. Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.

The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues.

In June 2006, the FDA was obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect leading to the permanent injunction.

On April 8, 2010, Baxter submitted a proposed correction schedule to the FDA that stated that Baxter did not plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012. The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013. On that schedule, a device with known safety concerns would remain in use on patients needing specialized care until 2013. FDA found this proposal unacceptable. The 2006 consent decree gave FDA authority to take any action it deemed appropriate. The FDA has determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague infusion pumps still in use.

Therefore the FDA is now ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers.

Infusion pumps, including the Baxter Colleague models, have been the source of persistent safety problems. In the past 5 years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.