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The FDA has approved deferiprone to treat transfusional iron overload in patients with thalassemia, a genetic blood disorder that causes anemia. Iron overload usually improves with chelation therapy, which uses chemical agents to remove excess iron from the body. Deferiprone is an iron chelator indicated when current chelation therapy is inadequate.
Common adverse reactions include nausea, vomiting, abdominal pain, arthralgia, chromaturia, neutropenia, and elevated serum alanine aminotransferase. In clinical studies, 2% of patients treated with deferiprone developed agranulocytosis, which can lead to serious infections and death.
Source: FDA news release. FDA approves Ferriprox to treat patients with excess iron in the body. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm275814.htm.
Clobazam has been approved by the FDA as an add-on medication for patients with Lennox-Gastaut syndrome, a severe form of epilepsy that's difficult to treat and affects less than 200,000 people in the United States. Two multicenter controlled trials were conducted on patients age 2 and older to test the drug's effectiveness when paired with ongoing seizure medication. In both studies, patients taking clobazam experienced fewer seizures compared with those taking a placebo or a lower dose of clobazam.
Common adverse reactions include somnolence, sedation, drooling, constipation, cough, urinary tract infection, insomnia, aggression, dysarthria, and fatigue. Clobazam may increase the risk of suicidal ideation and behavior; patients need to be monitored for depression and changes in mood or behavior. Withdrawal symptoms may occur with rapid dose reduction or discontinuation, so the drug should be discontinued gradually. It may also cause physical and psychological dependence; patients with a history of substance abuse should be monitored for habituation and dependence.
Because of its abuse potential, clobazam is categorized as a Schedule IV drug under the Controlled Substances Act.
Source: FDA news release. FDA approves Onfi to treat severe type of seizures. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm276932.htm.
The FDA released a public warning concerning the antineoplastic dasatinib, which is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia or acute lymphoblastic leukemia. Dasatinib may increase the risk of pulmonary arterial hypertension (PAH), a life-threatening condition that may occur anytime after the drug is initiated, including more than 1 year later.
Since dasatinib was approved in the United States in 2006, multiple cases of PAH linked to dasatinib have been reported. Healthcare providers should assess patients for cardiopulmonary disorders before and during treatment with dasatinib and permanently discontinue therapy in patients who develop PAH. Teach patients to immediately report signs and symptoms of PAH, such as dyspnea, fatigue, and fluid retention.
Source: FDA drug safety communication: sprycel (dasatinib) and risk of pulmonary arterial hypertension. http://www.fda.gov/Drugs/DrugSafety/ucm275155.htm.
Many newer antineoplastic agents, such as targeted therapies and immunotherapies, can cause hypothyroidism, thyrotoxicosis, and other thyroid disorders. In fact, many of these drugs cause thyroid dysfunction in 20% to 50% of patients, and some cause even higher rates. Yet, as noted in a new report, healthcare providers may overlook drug-induced thyroid problems because many signs and symptoms, such as fatigue, weakness, memory loss, cold intolerance, and cardiovascular effects, are common adverse reactions associated with cancer or cancer treatment. Because hypothyroidism and thyrotoxicosis are easily diagnosed with inexpensive blood tests, the authors recommend that patients receiving these newer antineoplastic drugs be routinely screened for thyroid dysfunction.
Source: Hamnvik OP, Larsen PR, Margusee E. Thyroid dysfunction from antineoplastic agents. J Natl Cancer Inst. 2011;103(21):1572-1587. Epub 2011 Oct 18.
One arm of a three-arm multicenter, clinical trial researching treatments for the lung-scarring disease idiopathic pulmonary fibrosis (IPF) has been stopped. IPF is a progressive and currently incurable condition affecting 200,000 people in the United States.
The cancelled arm consisted of a triple-drug therapy using prednisone, azathioprine, and n-acetylcysteine, a therapy widely used to treat IPF. Compared with participants in the placebo group, those taking the triple-drug therapy had higher mortality (11% versus 1%), more hospitalizations (29% versus 8%), and more serious adverse reactions (31% versus 9%). Researchers will continue to analyze the data from the completed arm of the study to determine why combining these three drugs is harmful to people with IPF.
Source: National Institutes of Health. Commonly used three-drug regimen for idiopathic pulmonary fibrosis found harmful. http://www.nih.gov/news/health/oct2011/nhlbi-21.htm.
Researchers observing the effects of nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, on postmenopausal women have found that NSAIDs were associated with a lower mortality in postmenopausal women who'd been diagnosed with colorectal cancer. The study looked at 160,143 postmenopausal women who reported no history of colorectal cancer. During the study, 2,119 cases of colorectal cancer were confirmed, and 492 women died from the disease.
After 10 years, the researchers reported that women in the study who took regular doses of NSAIDs had 30% lower colorectal cancer mortality. They concluded that if NSAIDs are used consistently over an extended period, they might lower colorectal cancer mortality in postmenopausal women.
Source: American Association for Cancer Research. NSAID use associated with lower colorectal cancer mortality rates among postmenopausal women. http://www.aacr.org/home/public-media/aacr-press-releases.aspx?d=2510.
Sitagliptin and simvastatin are now available as a fixed-dose combination medication as an adjunct to diet and exercise for adults with type 2 diabetes and dyslipidemia. Sitagliptin is a dipeptidyl peptidase-4 inhibitor that improves glycemic control. Simvastatin is an HMG-CoA reductase inhibitor (statin) used to reduce elevated total cholesterol, low-density lipoprotein cholesterol, triglycerides, and apolipoprotein B, as well as to increase high-density lipoprotein cholesterol. The new product is the first to combine a drug for type 2 diabetes with a statin.
The FDA has received postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis. If patients develop signs and symptoms of pancreatitis, the drug should be promptly discontinued.
Source: FDA approves combination therapy Juvisync. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274748.htm.
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