Treximet Approved for Migraines
The FDA approved Pozen Inc.’s Treximet to treat migraines. The drug combines GlaxoSmithKline’s Imitrex with the anti-inflammatory naproxen. Pozen had sought approval since 2005 and twice was asked by the FDA to provide more data.
There are 30 million migraine sufferers in the United States costing $15 billion annually in lost worker productivity. The network cited a migraine expert who said for many users, the combination drug would prove more effective than taking either medication alone.
The combination drug will include warning labels that could increase users’ risks of stroke, stomach bleeding, ulcers and heart problems.
Source: Health Day News, April 18, 2008
FDA Approved: Cimzia to Treat Crohn's Disease
Cimzia (certolizumab pegol) has been approved by the U.S. FDA to treat adults with moderate-to-severe Crohn’s disease who have not responded to conventional therapies. Cimzia, an injected drug, can cause side effects including headache, malnutrition, upper respiratory infection, abdominal pain, nausea and reactions at the injection site. Because the drug affects the immune system, people taking Cimzia are at increased risk of life-threatening infections. The drug also blocks tumor necrosis factor, which may contribute to the onset of lymphoma and other cancers.
Crohn’s, an inflammatory bowel disease, has no known cause or cure. Affecting more than 1 million people worldwide, it has symptoms including diarrhea, fever, bleeding, malnutrition, narrowing of the colon, obstructions, cramps and abdominal pain. Maker UBC Inc., of Smyrna, Ga., will be required to perform post-marketing studies that evaluate the drug’s long-term safety.
Source: Health Day News, April 22, 2008
FDA Launches Safety Reviews
The FDA is conducting safety reviews of Regranex Gel, Ziagen and Videx. All three are FDA approved medications.
The review of Regranex Gel, a skin product used to heal leg and foot ulcers, was prompted by study data suggesting there may be an increased risk of death from cancer in diabetic patients who use the gel. While the review is ongoing, health care professionals should discuss the risks and benefits of the product with patients. Recent findings from a study on anti-HIV drugs indicate that patients infected with HIV-1 who take Ziagen or Videx may have an increased risk of heart attack. Until the safety review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking.
Source: Health Day News, March 27, 2008
Sugar: The Not-So Sweet Story
Research has found evidence that sugar consumption interferes with immune function: When subjects were given refined sugar, their white blood cell count decreased significantly for several hours afterwards. Findings in other studies indicate a possible correlation between high blood sugar and endometrial cancer, breast cancer, pancreatic cancer, urinary tract cancer and melanoma.
Source: LifeScrpt, March 5, 2008
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How Cancer Drug Can Damage Kidneys
The sometimes controversial cancer drug Avastin can cause kidney damage by doing what it is supposed to – but in the wrong place. Avastin, whose generic name is bevacizumab, is the first member of a family of drugs designed to attack cancers by cutting off their blood supply. It does this by inhibiting the action of vascular endothelia growth (VEGF), a protein that promotes the growth of blood vessels.
One side effect of Avastin is proteinuria – excess protein in the urine, an indicator of kidney damage. The new study found that the damage is caused by inhibition of the growth of tiny blood vessels in the kidney. According to a study, the finding should not stop use of the medication. It helps to advice physicians to look out for this complication in treatment and also gives us a better handle on how to use the drug rationally in all cases.
Avastin was first approved by the U.S. FDA for treatment of lung and colon cancer. It became controversial when the FDA approved it for the use against advanced breast cancer, despite a 5-4 vote by an advisory committee against that approval. Committee members said the drug’s ability to slow tumor progression did not outweigh the damage done by side effects such as blood clots and cardiovascular problems.
Various studies have found proteinuria in anywhere from 21% to 64% of people given Avastin, the new study noted, but serious damage occurs in only 1% to 2% of users. Dr. Susan E. Quaggin, an associate professor of medicine at the University of Toronto, said, “We don’t actually know the true incidence of kidney damage. It is true that proteinuria is a very common finding, but it doesn’t necessarily mean that a patient should not get this drug. We need more studies to carefully follow the drug and see which patients get proteinuria and how common it is, because currently we don’t know.”
Source: Medical News Today, March 12, 2008
New Test Recommended to Determine
Cardiovascular Disease Risk
New guidelines may change the way doctors treat patients at risk for cardiovascular disease. The guidelines say an additional test should be added to the standard cholesterol test used to determine cardiovascular disease risk. The guidelines endorse the use of advanced lipoprotein testing by nuclear magnetic resonance (NMR) as a more accurate method to determine risk and to check whether LDL cholesterol lowering therapies are having an effect in patients.
NMR lipoprotein testing measures the number of LDL particles, which carry cholesterol through the body, rather than cholesterol levels alone. Studies have shown that it is the number of lipoprotein particles present in the blood, not the amount of cholesterol carried by these particles that form blockages inside arteries.
Source: Business Wire, March 30, 2008
CF Drug Shows Promise
An investigational oral drug called VX-770 showed promising results in treating cystic fibrosis (CF) patients who carry the G551D mutation of CF. A 14-day phase 2a trial of 20 patients found significant improvements in several key indicators of CF, including lung function, nasal potential difference measurements and sweat chloride (salt) levels. The findings suggest that the drug improves function of what is known as the CFTR protein.
Source: Associated Press, March 29, 2008 |
