Show #49, March 2006
Show #49, March 2006
|Tamiflu Approved for Flu Prevention in Children Under 12|
FDA recently approved the use of Tamiflu for preventing influenza in children 1 to 12 years old. Tamiflu was already approved as a preventive agent in patients 13 and older, and it is approved for treating the flu in patients older than 1 year.
The approval was based on a study of the spread of flu in households. When someone in the household was diagnosed with seasonal flu, other family members received either Tamiflu once a day for 10 days or no Tamiflu at all unless they became ill. Three percent of the children receiving Tamiflu prophylactically developed fever and other symptoms confirmed to be flu. That compared with 17 percent in the group receiving no preventative treatment. The benefit in children is similar to that seen in older individuals.
Side effects from Tamiflu taken prophylactically were similar to those in patients taking the drug therapeutically. In rare cases, anaphylaxis and serious skin reactions have occurred, so patients should be instructed to discontinue the drug if they develop an allergic reaction or severe rash.
Patients should also understand that Tamiflu is not a substitute for the flu vaccine, and that they should continue to receive annual vaccinations according to immunization guidelines.
- FDA Press Release - FDA Approves Tamiflu for Prevention of Influenza in Children Under Age 12. December 22, 2005.
|FDA Approves First Immune Globulin for Subcutaneous Use|
FDA recently approved a new immune globulin product that is injected subcutaneously. The product, called Vivaglobin, is made by the German company ZLB Behring. Until now, immune globulin products have been administered either intravenously or intramuscularly.
The approval of Vivaglobin provides a new way to administer antibody replacement therapy to patients with primary immune deficiency disease. This may be especially beneficial in patients who don't easily tolerate IV administration of IG because of poor venous access or serious side effects. Since Vivaglobin is injected on a weekly basis using an infusion pump, patients can self-administer the product at home.
In clinical studies, Vivaglobin was well tolerated. The most common side effects were mild or moderate injection site reactions such as swelling, redness and itching. The contraindications for Vivaglobin are similar to other immune globulin products.
- Product Approval Information - Licensing Action – Vivaglobin. January 9, 2006.
- FDA Press Release - FDA Approves First Immune Globulin for Subcutaneous Use. January 9, 2006.
|New Information on Paxil and Congenital Malformations|
New warnings have been added to the labeling for Paxil and generic paroxetine based on preliminary analyses of two recent unpublished epidemiologic studies. Both studies showed a relatively small increased risk for cardiac defects in infants born to women who received the drug in early pregnancy, and one study also showed an increased risk of congenital malformations overall.
In both studies, the most common types of cardiac abnormalities in children of women who took Paxil were atrial and ventricular septal defects, with a wide range of severity. Neither of the studies addressed the question of whether the risk might extend to use of the drug later in pregnancy.
FDA is recommends that Paxil generally not be started in women who are planning to become pregnant, or are in the first trimester of pregnancy. If a woman is already on Paxil, the physician should alert her about the potential risk to the fetus. The physician should also consider discontinuing the drug in these women, although in individual cases the benefits of continuing Paxil may outweigh the potential risk to the fetus. If Paxil is discontinued, it should be tapered off and not stopped suddenly.
|Recall of Vitros Confirmatory Test for Hepatitis B|
Ortho Clinical Diagnostics has recalled certain lots of the company's Vitros HBsAg Confirmatory Kit. This kit is used to confirm the presence of the antigen after a positive test with the Vitros HBsAg Reagent pack. Because of a problem with a diluting solution, the Confirmatory Kit may indicate “not confirmed” for some samples. This can cause some results to be classified as false negatives.
False negative results may prevent some patients infected with or carrying the hepatitis B virus from receiving necessary treatment. This is especially true for pregnant women whose tests show false negative results because a pregnant woman might be tested only for hepatitis B surface antigen and not for the core IgM antibodies. A “not confirmed” test result could lead to her newborn infant not being treated appropriately at birth, and this can have grave consequences. Without treatment, the infant is likely to progress to a chronic hepatitis B infection, and this can eventually lead to severe liver damage, the need for a liver transplant, or early death.
Ortho-Clinical sent letters via overnight mail to medical facilities, testing labs and public health agencies on 12/15/2005, instructing customers to discontinue use and discard remaining inventory. In a separate Q&A sheet, the company recommends that users go back and review the results that were previously reported by these confirmatory kits. Contact the company for this information, as well as the affected lot numbers.
|Suspended Marketing of NeutroSpec|
Mallinckrodt and Palatin Technologies have withdrawn from the market the imaging agent NeutroSpec because of serious safety concerns. NeutroSpec is used in nuclear medicine to help diagnose patients with equivocal signs and symptoms of appendicitis. It has also been used off-label for diagnosing osteomyelitis and other infections.
FDA received reports of seventeen patients receiving NeutroSpec who developed life-threatening cardiopulmonary side effects. These events occurred within minutes after injection and required that the patient be resuscitated with fluids, vasopressors and oxygen. In two cases, the patients died. There's no evidence that patients who've already received the drug safely face any long-term risk.
FDA is working with Palatin Technologies to evaluate these adverse events and determine whether further studies are needed to develop safer uses of the product. Meanwhile, healthcare providers must stop using NeutroSpec and contact the manufacturer immediately about returning all existing stocks.
If a patient should receive NeutroSpec despite this advice from the company and the FDA, he or she must be closely monitored for at least one hour after the drug is administered. Trained personnel and equipment should be on hand during that time to resuscitate the patient if needed. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complications.
|Avandia and Diabetic Macular Edema|
Glaxo SmithKline has notified health professionals about reports of diabetic macular edema in patients receiving Avandia (rosiglitazone maleate) which is used to treat type 2 diabetes. These reports involved both new cases of macular edema and worsening of existing cases. In the majority of instances, patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved when the drug was discontinued, and in one case it resolved after the dose was reduced.
- FDA MedWatch Safety Alert – Avandia (rosiglitazone maleate) Avandamet (rosiglitazone maleate/metformin HCl). January 5, 2006.
|Potentially Hazardous Interaction between Avinza and Alcohol|
Ligand Pharmaceuticals has notified healthcare professionals about revised labeling for Avinza morphine sulfate extended-release capsules. These changes highlight warnings that patients should not consume alcohol while taking the drug.
These warnings are based on FDA laboratory studies of Avinza. In these studies, morphine was released from the extended release tablets earlier than expected when the tablet was exposed to alcohol, and this effect increased dramatically with increasing alcohol concentration.
Although it is not clear that these findings are relevant to a clinical setting, patients who use Avinza should be told that they must not drink alcohol and must not use medicines that contain alcohol. Consuming alcohol while on the drug could result in the rapid release and absorption of a potentially fatal dose of morphine.
|Drug Name Confusion: Amicar and Omacor|
The Institute for Safe Medication Practices recently reported on mix-ups occuring between two drugs whose names sound and look alike: Amicar (aminocaproic acid) and Omacor. Amicar, an antifibrinolytic agent available for many years, is used to enhance hemostasis. Omacor, a relatively new product, is a preparation of omega-3 fatty acids that is used along with diet to lower very high triglyceride levels.
ISMP recently described a case where a pharmacist misunderstood a telephone order for Omacor 1 g BID as Amicar 1 g BID. Fortunately, the patient read the drug information sheet before taking the medication and called to let the pharmacist know he was expecting a drug that reduced his triglyceride levels.
ISMP says that if a patient inadvertently took Amicar instead of Omacor, the risk of thrombosis would be increased, along with a host of other adverse reactions. And substituting Omacor for patients that truly need Amicar may be even more significant, possibly leading to serious bleeding conditions.
FDA has received several other reports of mix-ups between these two drugs and we're working with the manufacturers to find ways to reduce the chance for confusion. In the meantime, ISMP says to set an alert in the order entry computer system, match the drug's indication to the patient's diagnosis before dispensing either of these drugs, and consider using tall man letters to help distinguish between the two drugs when both are available in the inventory.
|New Labeling for Food Allergens|
Patients are now going to have more information about whether packaged foods contain ingredients to which they are allergic. Effective January 1, 2006, FDA is requiring food labels to state clearly whether the product includes ingredients that contain proteins that are derived from one of the eight major food allergens. Those are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.
Although food labels are already required to list all the ingredients in the product, the new rule requires any ingredient that contains one of these allergenic proteins has to be clearly identified in plain English. For example, if a product contains casein, which is a milk protein, the label now has to use the term “milk,” so that a person allergic to milk will understand that he or she should avoid this product. That's especially important for children and their caregivers, who must learn to recognize the presence of substances that must be avoided.
About 160 foods have been identified as causing allergies, but the eight major food allergens covered by the new requirement are responsible for about 90 percent of all food allergies in the U.S. The requirements are quite specific. The label can't simply say “fish.” It has to state “flounder,” for example, or “cod.” The same holds true for the type of nut the food contains, or the type of shellfish.
The new law doesn't extend to food prepared in restaurants, so consumers will have to ask questions in the restaurant about ingredients. The law also doesn't apply to fresh fruits and vegetables or to highly refined oils that are made from one of the eight major food allergens, such as highly refined peanut oil or soybean oil, because these oils aren't considered to be major food allergens.
Any food labeled after January 1, 2006, has to have the new labeling. But the new law doesn't require that foods already on the shelves be removed or relabeled. That means that for some period of time, shoppers will continue to see foods in the marketplace that don't yet have the new labeling.
- FDA Press Release - FDA to Require Food Manufacturers to List Food Allergens. December 20, 2005.
- FDA Advice to Consumers: Food Allergen Labeling And Consumer Protection Act of 2004 Questions and Answers. December 12, 2005.
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