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The FDA has approved the first immune globulin product, called Vivaglobin, for under-the-skin (subcutaneous) injection to prevent serious infections in people with Primary Immune Deficiency Diseases (PIDD).
Vivaglobin, made from human plasma collected at U.S. licensed plasma centers, provides new delivery options for people who have PIDD. It is given on a weekly basis using an infusion pump, which means people can self-administer the product at home.
PIDD are inherited disorders that affect an estimated 50,000 people in the United States. People who have PIDD require regular treatment with immune globulin in order to fight off or prevent potentially serious or life-threatening infections.
Other immune globulin products are administered either into a vein (intravenously) or into muscle (intramuscularly). Some people develop problems that make it difficult to administer needed medicines intravenously, and Vivaglobin may be helpful in providing them with an alternative route.
In clinical studies, the most common side effects of Vivaglobin were mild or moderate injection site reactions such as swelling, redness, and itching.
As for all immune globulin preparations, plasma used for Vivaglobin is tested and found to be nonreactive for HIV and hepatitis viruses prior to its use, and the manufacturing process includes steps that further reduce the risk of transmission of viruses.
Vivaglobin is manufactured by ZLB Behring GmbH of Marburg, Germany.
An FDA operation found that nearly half of the imported drugs that the agency intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian" pharmacies. Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 countries. A number of these products also were found to be counterfeit.
"These results make clear there are Internet sites that claim to be 'Canadian' that, in fact, are peddling drugs of dubious origin, safety, and efficacy," says Acting FDA Commissioner Andrew von Eschenbach, M.D. "We believe that these 'bait and switch' tactics--offering patients one thing and then giving them something else--are misleading to patients and potentially harmful to the public health."
The FDA conducted its "Operation Bait and Switch" over a few days in August 2005 at the John F. Kennedy International Airport in New York, Miami International Airport, and Los Angeles International Airport. The FDA examined all mail parcels suspected of containing pharmaceuticals sent from four countries--India, Israel, Costa Rica, and Vanuatu--that the agency had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian.
Out of nearly 4,000 parcels examined, almost 1,700, or about 43 percent, had been ordered from "Canadian" Internet pharmacies and were represented as being of Canadian origin. However, only 15 percent of these "Canadian" drugs actually originated in Canada. The remaining 85 percent were manufactured in 27 different countries. In addition to having been falsely promoted as being of Canadian origin, many of these drugs were not adequately labeled in English to help assure safe and effective use.
Thirty-two of the pharmaceuticals sampled, representing three distinct drug products, were determined to be counterfeit. The FDA is working closely with the Canadian drug regulatory and law enforcement authorities on this matter. Visit www.fda.gov/importeddrugs/ for more on imported drugs and www.fda.gov/counterfeit/ for additional information on counterfeits.
The FDA has approved Nexavar (sorafenib tosylate), a new anti-cancer medicine used to treat adults with advanced renal cell carcinoma, the most common type of kidney cancer.
The approval of Nexavar in December 2005 brings a much-needed option for this group of cancer patients, says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "The FDA is working hard to support the development of new and effective treatments for patients with cancer and other serious illnesses who have limited alternatives," Galson says.
In the United States, kidney cancer accounts for about 3 percent of all adult cancers. According to the American Cancer Society, about 32,000 new cases are diagnosed, and about 12,000 people die from the disease annually. Kidney cancer occurs most often in people between the ages of 50 and 70, affects men almost twice as often as women and, if detected early enough, may be curable surgically. But tumors that are advanced are difficult to treat. These are tumors that cannot be surgically removed or have spread to other parts of the body.
Two studies in people with advanced kidney cancer have shown that those treated with Nexavar had more time before tumor progression or death. In the larger study, most patients had previously received treatment with interleukin-2 or interferon. The median time to tumor progression or death in the Nexavar treated arm was 167 days compared to 84 days in people not treated with the drug.
Some common, temporary side effects reported with Nexavar are rash, diarrhea, increases in blood pressure, redness, pain, swelling, or blisters on the palms of the hands or on the soles of the feet.
Nexavar will be marketed by Bayer Pharmaceuticals Corp. of Westhaven, Conn.
The FDA has approved the drug Revlimid (lenalidomide) for the treatment of a subtype of Myelodysplastic Syndrome (MDS) called deletion 5q cytogenetic abnormality.
MDS is a collection of disorders in which the bone marrow does not function normally and the body does not make enough normal blood cells. About 7,000 to 12,000 new cases of MDS are diagnosed yearly in the United States. Although MDS occurs in all ages, the highest prevalence is in people older than 60. Typical symptoms of MDS include weakness, fatigue, infections, easy bruising, bleeding, and fever.
People with MDS may need blood and platelet transfusions and antibiotic therapy for infections. In clinical trials, those treated with Revlimid no longer needed transfusions, with most patients becoming independent of transfusion by three months. The transfusion-free period lasted an average of 44 weeks.
"This new product will offer a much needed treatment option for patients suffering from this rare illness that, in some cases, has been found to progress to fatal forms of leukemia," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research.
MDS can develop after treatment with drugs or radiation therapy for other diseases, or it can develop without any known cause. Some forms of MDS can progress to acute myeloid leukemia (AML), a type of cancer in which too many white blood cells are made.
Revlimid is structurally similar to thalidomide, a drug known to cause severe birth defects. Additional studies are ongoing in animals to address whether there is a risk that Revlimid will also cause birth defects when taken during pregnancy. While these studies are under way, the company is marketing Revlimid under a risk management plan called RevAssist, designed to prevent fetal exposure.
The FDA and the manufacturer will re-evaluate the risk management plan when results of further animal testing for birth defects are completed.
The labeling for Revlimid will include a "black box" warning and a Medication Guide regarding the prevention of fetal exposure. Additional black box warnings include the potential need to lower the dose because of suppressed blood counts and increased risk of blood clots.
Revlimid is distributed by Celgene Corp. of Summit, N.J.
Early results of new studies for Paxil (paroxetine) suggest that the drug increases the risk of birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved to treat depression and several other psychiatric disorders. The FDA is gathering additional data and waiting for final results of the studies to better understand the higher risk of birth defects.
The FDA advises health care professionals to discuss this potential risk with women who plan to become pregnant or are in the first three months of pregnancy. Health care professionals should consider discontinuing Paxil and switching to another antidepressant in these patients. But for some women who have already been taking Paxil, the benefits of continuing the drug may be greater than the potential risk to the fetus.
"Stopping these medicines on your own can sometimes create more problems than it solves," says Sandra Kweder, M.D., deputy director of the FDA's Office of New Drugs. "A lot of these medicines are associated with withdrawal syndromes, which can be very problematic for many patients, so stopping is something that needs to be monitored carefully by your doctor."
The FDA advises health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.
Early results of two studies indicate that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were holes in the walls of the chambers of the heart (atrial and ventricular septal defects).
The FDA has asked Paxil's manufacturer, GlaxoSmithKline (GSK) of Research Triangle Park, N.C., to change the drug's pregnancy category from C to D, which is a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the fetus.
GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has been changed to reflect the latest data. Visit www.fda.gov/cder/drug/advisory/paroxetine200512.htm for more information.
Two topical eczema drugs now carry a "black box" warning about a possible risk of cancer. The FDA approved the updated labeling with the warning for Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The agency also approved a consumer-friendly medication guide that pharmacists are required to give to patients when dispensing these prescription drugs to make them aware of this concern.
The new labeling also clarifies that these drugs are recommended for use as second-line treatments, meaning that other prescription topical medicines should be tried first. Use of these drugs in children younger than 2 is not recommended.
People who have eczema, or atopic dermatitis, have chronic itching and dry skin. Both drugs are applied to the skin to help control eczema.
Although a causal link has not been established, rare reports of cancer have been reported in people who had been using these products.
Studies are being conducted by the manufacturers of both drugs to try to answer questions about cancer risk, but it could be many years before the research is concluded. In the meantime, there is a benefit associated with these drugs when used appropriately.
Novartis Pharmaceuticals Corp. manufactures Elidel Cream and Astellas Pharma Inc., formerly Fujisawa Healthcare, manufactures Protopic Ointment.
Hundreds of samples of fish and shellfish from the waters affected by Hurricanes Katrina and Rita have come back contaminant-free, according to local, state, and federal officials, and there is no reason for people to be concerned about consuming seafood from the Gulf region because of the hurricanes.
The samples were analyzed for chemical and microbiological contaminants that could have been introduced by the hurricanes. The extensive seafood tissue sampling occurred in an area from the estuaries of New Orleans to Gulf Shores, Ala. The sampled areas included Lake Pontchartrain, Mississippi Sound, and Mobile Bay, as well as the offshore areas of the northern Gulf of Mexico. Officials from Alabama, Mississippi, Louisiana, the FDA, the federal Environmental Protection Agency, and the National Oceanic and Atmospheric Administration were involved in the tests and analyses.
Additional monitoring is being done, and results will be announced as they become available.
To gain a better understanding of the health outcomes associated with marketed drugs, the FDA and the Agency for Healthcare Research and Quality (AHRQ) are launching an effort that will advance scientific research and will foster future research partnerships.
"Through this collaboration, we will gain an improved understanding of the health outcomes associated with marketed drugs that we will leverage to improve the quality of information we provide to the public," says Gerald Dal Pan, M.D., director of the FDA's Office of Drug Safety.
This endeavor also will include promoting collaborative drug safety and effectiveness research by the Centers for Medicare and Medicaid Services and by academic and professional organizations.
"The Effective Health Care Program compares treatment alternatives, including drugs, and communicates its findings broadly to help patients and health care providers make the best choices in their health care," says Jean R. Slutsky, director of the AHRQ's Center for Outcomes and Evidence. "A closer association between the AHRQ and the FDA will help both agencies serve consumers and health care professionals better."