- FDA Approves Privigen for ITP
- Baxter Launching Program to Ensure Access to its IVIG
- Drug-Induced Thrombocytopenia
- Plavix Linked to Thrombotic Thrombocytopenic Purpura
- Drug Safety Website
- Doctors Dismiss Patient Reports on Side Effects
- AKR-501 Being Developed for ITP
- Zingo to Reduce Pain of Needle Pricks
- Dengue Fever Spreading in Southeast Asia—May Help Vaccine Development
- Online Tools Help Manage Medical Bills
- Hospitals Rely More Heavily on Patient Advisers
FDA APPROVES PRIVIGEN FOR ITP
The Food and Drug Administration granted marketing approval for a new intravenous immunoglobulin (IVIg) for treating patients with primary immunodeficiency and chronic ITP. Privigen, manufactured by CSL Behring (King of Prussia, PA), requires no refrigeration or reconstitution.
BAXTER LAUNCHING PROGRAM TO ENSURE ACCESS TO ITS IVIG
Starting in 2008, Baxter (Deerfield, OH) will enable patients to enroll in a program that offers continued access to its two intravenous immune globulin products, GAMMAGARD LIQUID and GAMMAGARD S/D, even if the patient’s physician or other provider changes access to another product.
Dozens of medications can cause drug-induced thrombocytopenia, or low platelet count, according to a review by Wisconsin-based researchers. Oftentimes, when exposure to a drug leads to destruction of circulating platelets and bleeding symptoms in non-hospitalized patients, the patient is treated for autoimmune thrombocytopenia and can have two or three recurrences before the drug causing the disorder is identified. Though uncommon, drug-induced thrombocytopenia can have devastating consequences, which can usually be prevented by discontinuing the causative drug. Corticosteroids are often given, but there is no evidence that they are helpful. Patients should be advised to permanently avoid the medication thought to be the cause. The authors list the drugs most commonly involved, including heparin, quinine, and certain analgesics.
PLAVIX LINKED TO THROMBOTIC THROBOCYTOPENIC PURPURA PLAVIX (Sanofi-Aventis)
will carry new safety warnings on its label, with FDA approval, to warn that rare cases of thrombotic thrombocytopenic purpura (TTP) have been reported, even after a short period of use. Plavix, clopidogrel bisulfate tablets, is used for certain cardiac patients. TTP is a rare, but serious condition that requires plasmapheresis, or cleansing of the blood through a machine.
DRUG SAFETY WEBSITE
iGuard promotes itself as “the fastest and easiest way to get personalized safety alerts and updates for your medicines.” The website requires the user to register. It does not seem to require a user fee, but how it is funded is unclear.
DOCTORS DISMISS PATIENT COMPLAINTS OF DRUG EFFECTS
Although muscle pain and other side effects occur in up to 30% of patients taking statins (such as Lipitor and Zocor), a recent survey found that when statin patients complained of muscle pain, their doctors often attributed the symptoms to the normal aging process, or dismissed the symptoms altogether. This becomes a problem for the patient, but also for other patients, because if the doctor is not reporting the so-called “adverse event” to the FDA, then the regulatory agency underestimates the problem, and other doctors and patients assume the drug is safer than it is. The study suggested that this pattern of nonreaction goes beyond statins to other drugs. U.S. patients can report side effects to the FDA themselves, via the FDA Website called MedWatch (http://www.fda.gov/medwatch).
AKR-501 BEING DEVELOPED FOR ITP
MGI Pharma (Minneapolis) has obtained rights to develop AKR-501, a “novel, orally-available small molecule thrombopoietin mimetic” for treatment of low platelet count. It stimulates a receptor on the surface of bone marrow cells called megakaryocytes to boost platelet production. The drug is in a phase 2 trial for ITP.
ZINGO TO REDUCE PAIN OF NEEDLE PRICKS
The FDA approved Zingo to locally reduce pain for IV insertions or blood draws for children ages 3 to 18. Zingo is a lidocaine powder that is administered through a needle-free, pre-filled, disposable device. It reduces pain when given just one to three minutes before a shot or IV procedure.
DENGUE FEVER SPREADING IN SOUTHEAST ASIA
Because dengue fever, a deadly disease spread by mosquitoes, is hitting countries in Asia and Latin America that are experiencing economic booms, and because the disease does not discriminate between rich and poor, researchers are newly optimistic that drug makers are seeing a strong potential market for developing an effective vaccine. The disease is taking a high economic toll, and so these countries would be willing to pay more for a vaccine.
(Note: Dengue fever can cause thrombocytopenia and bleeding. It is sometimes confused with ITP)
ONLINE TOOLS HELP MANAGE MEDICAL BILLS
Consumers can now use online services to organize medical bills. Unlike older services that were only available through employers or health plans, newer services are available directly to consumers. Examples include: MedBillManager, which charges $25/year. Steve Case’s Revolution Health charges $129/year to manage medical bills, answer medical questions, and fight disputed claims on a user’s behalf. SmartMedicalConsumer is free. It manages medical bills and provides automatic error detection. Consumers should create and regularly update their own personal health record of important medical information, including when medical bills are paid.
HOSPITALS RELY MORE HEAVILY ON PATIENT ADVISERS
Hospitals are creating advisory councils whose members help “plan new facilities, set hiring standards and interview job candidates.” Patient advisers help plan clinical trials, and review medication safety measures. This move to involve patients in decision-making makes sense, since, starting next year, Medicare will require hospitals to publish customer-satisfaction data on the Medicare Website.