FDA approves injectable drug to treat opioid-dependent patients

The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

Vivitrol is an extended-release formulation of naltrexone administered by intramuscular injection once a month. Naltrexone works to block opioid receptors in the brain. It blocks the effects of drugs like morphine, heroin, and other opioids. It was approved to treat alcohol dependence in 2006.

“Addiction is a serious problem in this country, and can have devastating effects on individuals who are drug-dependent, and on their family members and society,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “This drug approval represents a significant advancement in addiction treatment."

The safety and efficacy of Vivitrol were studied for six months, comparing Vivitrol treatment to placebo treatment in patients who had completed detoxification and who were no longer physically dependent on opioids. Patients treated with Vivitrol were more likely to stay in treatment and to refrain from using illicit drugs. Thirty-six percent of the Vivitrol-treated patients were able to stay in treatment for the full six months without using drugs, compared with 23 percent in the placebo group.

Patients must not have any opioids in their system when they start taking Vivitrol; otherwise, they may experience withdrawal symptoms from the opioids. Also, patients may be more sensitive to opioids while taking Vivitrol at the time their next scheduled dose is due. If they miss a dose or after treatment with Vivitrol has ended, patients can accidentally overdose if they restart opioid use.

Side effects experienced by those using Vivitrol included nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps. Other serious side effects included reactions at the site of the injection, which can be severe and may require surgical intervention, liver damage, allergic reactions such as hives, rashes, swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts, and suicidal behavior.

Vivitrol should be administered only by a physician as an intramuscular injection, using special administration needles that are provided with the product. Vivitrol should not be injected using any other needle. The recommended dosing regimen is once a month.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Vivitrol is manufactured by Alkermes, Inc.

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FDA Approves Therapy to Treat Gaucher Disease

/PRNewswire/ -- The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. Without this enzyme, harmful amounts of a certain fatty substance (lipid) can build up in the liver, spleen, bones, bone marrow and nervous system, and can prevent cells and organs from working properly. About 1 in 50,000 to 1 in 100,000 people in the general population have Gaucher disease.

VPRIV provides long-term enzyme replacement therapy for Type 1 Gaucher disease, the most common form of the genetic disorder. It is an alternative to Cerezyme (imiglucerase), another enzyme replacement therapy. Cerezyme is currently in short supply.

"The approval of VPRIV will provide a safe and effective alternative treatment for patients with Gaucher disease," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "Patients who previously received Cerezyme as an enzyme replacement therapy for their Type 1 Gaucher disease can be safely switched to VPRIV."

The safety and effectiveness of VPRIV was assessed in three clinical studies involving 82 patients with Type 1 Gaucher disease ages 4 years and older. The studies included patients who switched to VPRIV after being treated with Cerezyme.

The most common adverse reactions to VPRIV are allergic reactions. Other observed adverse reactions with VPRIV are headache, dizziness, abdominal pain, back pain, joint pain, nausea, fatigue/weakness, fever, and prolongation of activated partial thromboplastin time, a measure of clotting time.

VPRIV is manufactured by Shire Human Genetic Therapies Inc. of Cambridge, Mass.

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FDA Approves First Imaging Agent to Enhance Scans of Blood Flow

The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.

Although MRA can be performed without the use of a contrast imaging agent, Vasovist administration provides a clearer image in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs. The MRA is performed using magnetic resonance imaging (MRI), which relies on magnetic fields to create highly detailed images of the inside the body.

"This MRA contrast imaging agent provides clinicians with a much clearer scan of blood vessels, compared to MRA without contrast, even in vessels that are difficult to scan because they twist and turn in the body," said John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, FDA.

When blood vessels are scanned using MRA without any contrast, radiologists are unable to interpret the images about 10 percent to 30 percent of the time. As a result, radiologists have typically used X-rays to detect blood vessel abnormalities. But this is a lengthy procedure and requires sticking a needle into an artery to inject the X-ray dye, a procedure that may result in injury to vessel walls, blood clots, allergic reactions and potential kidney damage. Vasovist is injected into a peripheral vein and no artery is punctured, thus the potential risks are fewer.

The active substance in Vasovist is gadolinium, a rare earth metal element that is detected by MRI scanners. When injected, gadoliunium interacts with water molecules in the body, giving a stronger signal and, in turn, a better picture.

The safety and efficacy of Vasovist was established in two clinical studies of patients with known or suspected aortoiliac disease --- plaque buildup in the arteries going to the legs. In the studies, patients underwent MRA with and without Vasovist and their scans were compared to standard X-ray pictures using contrast. MRA with Vasovist detected more arterial disease than MRA performed without Vasovist and the pictures were of improved technical quality.

The primary safety risks for Vasovist are allergic reactions and n ephrogenic systemic fibrosis, a rare syndrome that involves the thickening of the skin, joints, eyes and internal organs. The FDA issued a warning about this syndrome in May 2007 and information about it is included in a boxed warning for all drugs containing gadolinium, including Vasovist. The warning can be found here:
http://www.fda.gov/cder/drug/InfoSheets/HCP/gcca_200705.htm

Vasovist Injection is manufactured by EPIX Pharmaceuticals Inc., Lexington , Mass.

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Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP

Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is following up on a nationwide voluntary recall issued Sept. 18 of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers because a small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.

The product contains 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride. The product name and National Drug Code (NDC) number printed on the container are correct. The affected lot was shipped to U.S. customers between July 2008 and September 2008. No other lots are affected by this recall.

Hospira has not received any reports of adverse health events in connection with the recalled lot. Hospira has identified the root cause of the error and taken action to prevent its recurrence.

Anyone with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it. Customers who have medical questions should contact Hospira Medical Communications at 1-800-615-0187. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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FDA Approves Updated Labeling for Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

"As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks."

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug's use.

One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Raptiva was approved in 2003. It is manufactured by Genentech, Inc. of San Francisco, Calif.

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