* A new drug for chronic hepatitis B in adults.
Telbivudine (Tyzeka), a drug representing a new molecular entity, is now available to treat chronic hepatitis B in adults. It is an antiviral agent that suppresses the hepatitis B virus and reduces the liver inflammation that accompanies the infection. The antiviral effectiveness of the drug is comparable to that of others currently being used to treat hepatitis B, such as lamivudine (Epivir, Epivir-HBV, and others), and like them, telbivudine does not cure chronic hepatitis B--patients who take the drug still are at risk for transmitting the virus through either sexual contact or contaminated blood. The most common adverse effects of telbivudine generally are mild to moderate and include an elevated level of creatine phosphokinase, upper respiratory tract infection, fatigue, headache, abdominal pain, cough, and transient muscle pain and muscle weakness, the latter of which improved significantly upon cessation of administration. However, because cessation of the drug therapy can induce sudden and severe worsening of hepatitis B, patients should be monitored closely for at least several months after discontinuing treatment.
U.S. Food and Drug Administration. FDA news: FDA approves new treatment for chronic hepatitis B in adults. 2006 Oct. http://www.fda.gov%2fbbs%2ftopics%2fNEWS%2f2006%2fNEW01498.html.
* A new nasal spray treats hay fever symptoms in adults and in children older than age 12.
Ciclesonide (Omnaris) is a new nasal spray that treats seasonal and perennial allergic rhinitis (commonly known as hay fever), decreasing the incidence of runny nose, sneezing, nasal itching, and nasal congestion. Ciclesonide is a corticosteroid that can be used by patients 12 years of age and older. The most common adverse effects are headache, nosebleed, and inflammation of the linings of the nose and throat.
U.S. Food and Drug Administration. FDA news: FDA approves new treatment for allergies. 2006 Oct 23. http://www.fda.gov%2fbbs%2ftopics%2fNEWS%2f2006%2fNEW01495.html.
* Risperidone is the first drug approved for the treatment of behavioral symptoms of autism in children and adolescents.
Risperidone (Risperdal), an antipsychotic agent used in adults, has now been approved to treat irritability (behavior including aggressiveness, injury deliberately inflicted on the self, and temper tantrums) in children and adolescents with autism. For use in patients as young as five years old, the most common adverse effects of risperidone seen in the pediatric population are drowsiness, constipation, fatigue, and weight gain.
U.S. Food and Drug Administration. FDA news:FDA approves the first drug to treat irritability associated with autism, Risperdal. 2006 Oct 6. http://www.fda.gov%2fbbs%2ftopics%2fNEWS%2f2006%2fNEW01485.html.
* A new combination therapy for lung cancer is approved.
Bevacizumab (Avastin) was approved for use in combination with carboplatin (Paraplatin) and paclitaxel (Onxol, Taxol) in the initial systemic treatment of unresectable, locally advanced, recurrent or metastatic, nonsquamous, non-small cell lung cancer after survival was found to have increased by two months with the therapy, compared with the use of carboplatin and paclitaxel alone, which is the standard treatment. Bevacizumab already is approved for use with iv 5-fluorouracil as the first- or second-line chemotherapy treatment in patients with metastatic cancer of the colon or rectum.
U.S. Food and Drug Administration. FDA news: FDA approves new combination therapy for lung cancer. 2006 Oct 12. http://www.fda.gov%2fbbs%2ftopics%2fNEWS%2f2006%2fNEW01488.html.
* A new type 2 diabetes drug enhances the body's natural ability to lower elevated serum levels of glucose.
Merck recently has been granted approval for sitagliptin (Januvia), a new drug used to treat type 2 diabetes, and the first of a new class of drugs that inhibit DPP4, an endogenous enzyme that inactivates the incretin hormones that are released at greater levels after food consumption in response to elevated serum glucose levels; the inhibition of the enzyme allows the hormones to continue to act. Because sitagliptin increases the release of insulin and decreases glucagon levels according to blood glucose level, hypoglycemia is not an adverse effect. Sitagliptin is taken orally once daily, either with or without food and adjunctively to appropriate diet and exercise, as monotherapy or in combination with other commonly prescribed oral drugs to treat diabetes, except those in the sulfonylurea class, such as glyburide, as well as insulin, whose use concurrently with sitagliptin has not been researched adequately. Sitagliptin is considered unlikely to produce drug interactions, either through the cytochrome P-450 isoenzyme system or through competition at protein-binding sites. In the presence of moderate to severe renal insufficiency or renal failure and during periods of stress, such as after surgery or trauma or in the presence of infection or fever, a decreased dosage of the drug might be warranted and would require prompt medical attention and close monitoring of the blood glucose level. Sitagliptin is a pregnancy category B drug; the most common adverse effects are upper respiratory infection, nasopharyngitis, and headache; gastrointestinal disturbances such as abdominal pain, nausea, and diarrhea also have been observed.
U.S. Food and Drug Administration. FDA news: FDA approves new treatment for diabetes: first in a new class of diabetes drugs. 2006 Oct 17. http://www.fda.gov%2fbbs%2ftopics%2fNEWS%2f2006%2fNEW01492.html%3b U.S. Food and Drug Administration. [Label information]: Highlights of prescribing information: Januvia (sitagliptin phosphate) tablets. 2006. http://www.fda.gov%2fcder%2ffoi%2flabel%2f2006%2f021995lbl.pdf.