- FDA Announcements
Tougher warnings on painkillers
- Animal Study Suggests Role for Arsenic Compound to Treat B-Cell Autoimmunity
- Evidence Building for Vitamin D’s Benefits
- Medical Offices Could Use a Safety Check
- Curry May Help Brainpower
- Do Gut Bacteria Play Role in Obesity?
- Uninsured and low-income patients can get help paying for medications
- Helpful Websites
Rituxan (rituximab) is approved by the Food and Drug Administration (FDA) for treatment of certain types of lymphoma and for rheumatoid arthritis that has not responded to other therapies. However, the drug is also prescribed in what is called off-label indications for patients with lupus and patients with ITP.
After two patients taking Rituxan for lupus died from a rare brain infection, the Food and Drug Administration and the drug’s makers, Genentech and Biogen Idec, released a “preliminary public safety alert”. It warned doctors to carefully monitor patients taking Rituxan for any reason. The link between Rituxan and the viral brain infection, called progressive multifocal leukoencephalopathy, or PML, is unclear. The drug’s label already includes a warning about PML. And also states that patients who are carriers of the Hepatitis B virus (which means persistently having the virus, not just having a past infection), are at risk of reactivating the hepatitis B with Rituxan treatment. However, when given on its own as a treatment for ITP, Rituxan has not been associated with infections.
The FDA is not suggesting that Rituxan be pulled from the market. The side effect is rare and appears to occur only in people who have received multiple immunosuppressive treatments in addition to Rituxan. Dr. James Bussel, a PDSA medical advisor, states: “We do not believe that this should alter clinical practice unless the patient is receiving multiple immunosuppressive treatments in addition to Rituxan.”
The FDA would like to see stronger labeling rules on over-the-counter painkillers to warn consumers of the risks of stomach bleeding or liver injury. Nonprescription drugs such as ibuprofen (Advil, Motrin), acetaminophen (Tylenol), and aspirin, can cause serious health problems, especially if consumers take too much of a given product, which can occur when people take a combination of over-the-counter cold medicine and another pain reliever. The drugs are safe, but consumers need to be aware of possible side effects and to avoid accidentally overdosing when taking multiple products. The FDA proposal would require all manufacturers to use the same language and make current warnings more prominent.
Wall Street Journal, December 20, 2006, pg D4
UNAPPROVED QUININE PRODUCTS
The FDA has ordered the removal of unapproved drug products containing quinine. The only quinine product currently approved by the FDA is called Qualaquin, by Mutual Pharmaceutical Company. It is indicated for the treatment of a specific type of malaria. But it is often prescribed to treat leg cramps and similar conditions, despite drug labeling that the risks associated with its use in this setting outweigh the potential benefits.
Close monitoring may be required for patients with liver or kidney problems. Serious adverse events include cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions; potentially serious interactions with other drugs are also possible.
Medscape Medical News, December 13, 2006.
ANIMAL STUDY SUGGESTS ROLE FOR ARSENIC COMPOUND TO TREAT SYSTEMIC B-CELL AUTOIMMUNITY
Arsenic trioxide is a poison that is used to treat acute promyelocytic leukemia. In a mouse model of lupus, the drug halted disease progression through various mechanisms. In a commentary, Pistoia writes that the latest study supports the feasibility of a clinical trial in treatment-resistant patients with lupus or possibly autoimmune lymphoproliferative syndrome.
Pistoia V. Poisoning Autoimmunity. Blood, December 15, 2006, 108(13):3964.
EVIDENCE BUILDING FOR VITAMIN D’S BENEFITS
Scientists now think that vitamin D, which many people do not get enough of, has many more benefits than reducing the risk for rickets. Studies link low blood levels of vitamin D to type 1 diabetes, multiple sclerosis, tuberculosis, colon cancer and flu. High levels prevent against fractures. Our bodies make vitamin D when we get exposure to the sun, but most people spend a lot more time indoors than outdoors, or avoid sun exposure to reduce the risk of skin cancer. Food sources are limited to fortified milk products and new research suggests that the recommended dietary allowance, or RDA, is not sufficient. Meir J. Stampfer, professor of medicine at Harvard Medical School, writes that there is growing agreement among experts that a daily vitamin D supplement makes good sense.
Newsweek, December 11, 2006, pg. 85-86.
MEDICAL OFFICES COULD USE A SAFETY CHECK
Many doctor’s offices fall short when it comes to keeping track of patients, their appointments, and their test results. According to one non-profit group, too many errors occur because of poor communication with referring physicians, inadequate communication with the patient, or inadequate follow-up. Three organizations are offering a new, Web-based “Physician Practice Patient Safety Assessment” to help doctors evaluate how well they run their offices, with a focus on tracking medication use and safety, transferring information to other doctors, and communicating to patients. The tool was developed by the nonprofit Medical Group Management Association, the Institute for Safe Medication Practices, and Health Research and Educational Trust, under a grant from the Commonwealth Fund. Any doctor can download the self-assessment program free at www.physiciansafetytool.org. For a fee, the group will analyze the data and provide a report. Patients can also download materials to get a sense of what their doctors’ offices should be doing.
To help patients do their part, HMO giant Kaiser Permanente is including “after visit summaries” that recount the salient points of a doctor visit, describe prescription medications and doses, and lay out instructions for self-care and follow-up visits.
Landro, L. The Informed Patient. Booking Your Medical Office for a Safety Checkup. Wall Street Journal, November 15, 2006, page D3.
CURRY MAY HELP BRAIN POWER
Diets High in curry may prevent cognitive impairment, according to a study in the Nov. 1 American Journal of Epidemiology. A chemical found in turmeric, an ingredient in curry, had earlier shown anti-inflammatory and anti-cancer properties in animal studies. For this study, medical researchers in Singapore evaluated a database of about 1,000 elderly, mentally sound adults, and found that those who stated they ate curry often or occasionally had slightly higher scores on cognitive-function tests than those who reported rare or no curry consumption.
Science News, November 11, 2006, Pg. 316.
DO GUT BACTERIA PLAY ROLE IN OBESITY?
Obese mice—and people—have more of one type of bacteria and less of another kind, according to two studies published in the journal Nature in January. A family of bacteria called Firmicutes was high among the obese and a type of bacteria called Bacteroidetes were low. The researchers aren’t sure if more Firmicutes makes people fat or if people who are obese grow more of that type of bacteria. Could changing the bacteria in the intestines and stomach make a difference?
In one study, lean mice with no germs in their guts were given larger ratios of Firmicutes. Subsequently, they got twice as fat and took in more calories from the same amount of food than mice with the more normal bacteria ratio. In a second study of obese people, 3 percent of their gut bacteria was Bacteroidetes before dieting. After successful dieting, their levels of Bacteroidetes were much higher.
The studies were done at Washington University in St. Louis.
UNINSURED AND LOW-INCOME PATIENTS CAN GET HELP PAYING FOR MEDICATIONS
Many patient advocacy organizations, pharmaceutical companies, foundations, and other charitable organizations have programs to help patients pay for prescription therapies. To qualify for PAPs and cost-sharing assistance programs, patients must meet income guidelines and other eligibility criteria. The Patient Advocate Foundation ( www.copays.org or 1-866-512-3861) is one of many good resources.
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