New Version of Depression Treatment
The FDA approved escitalopram oxalate (Lexapro), the single isomer of citalopram HBr (Celexa), for treating major depression.
The recommended dose of escitalopram, a selective serotonin reuptake inhibitor, is 10 mg daily. In a clinical trial, escitalopram's 10-mg dose was comparable to the higher titrated dose of citalopram at 40 mg daily. According to the manufacturer, many patients taking escitalopram showed improvement in depressive symptoms after the first or second week of treatment.
In trials comparing escitalopram, citalopram, and placebo, escitalopram was well tolerated at doses of 10 and 20 mg per day. The drugs most common adverse effects were nausea, insomnia, ejaculation disorder, increased sweating, and fatigue.
Help for Children with High Cholesterol
The FDA has approved Pfizer's atorvastatin calcium (Lipitor) for use in children aged 10 to 17 with familial hypercholesterolemia. In a clinical study, atorvastatin, 10 mg and 20 mg taken daily, were well tolerated and effective as an adjunct to diet in lowering total cholesterol and low-density lipoprotein cholesterol (LDL) in boys and postmenarchal girls aged 10 to 17 with heterozygous familial hypercholesterolemia.
Children should be considered for the 10 mg or 20 mg dose of atorvastatin if diet therapy is unsuccessful and if LDL remains 190 mg/dL or greater, or if LDL remains 160 mg/dL or greater and there is a positive family history of premature cardiovascular disease, or two or more other cardiovascular risk factors are present in the pediatric patient.
In a clinical study of adolescent boys and girls with hypercholesterolemia, patients treated with atorvastatin had adverse events similar to those of placebo patients. The most common adverse events in both groups were infections. No detectable effect on growth or sexual maturation in boys or menstrual cycle length in girls was observed. The long-term efficacy of atorvastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.
Consult product labeling for specific prescribing instructions.
Prescribing Changes for RSV Drug
MedImmune, Inc. is advising health care practitioners of several changes to the prescribing information for palivizumab (Synagis).
The Warnings section of the updated product label has been changed to clarify the risk of anaphylaxis. At the time palivizumab was licensed, no cases of anaphylaxis were observed; however, the protein nature of the product was such that these reactions could be anticipated and therefore presented as a theoretical risk statement.
Since licensing, two cases of anaphylaxis have been reported. Both patients made a full recovery with appropriate therapy. While the occurrences were very rare (more than 400,000 patients and 2 million doses of the drug have been reviewed), the risk of anaphylaxis has changed from theoretical to actual, but very rare. Thus, the Warnings section of the label has been modified to include this sentence: "If anaphylaxis or severe allergic reactions occur, administer appropriate medications (such as epinephrine) and provide supportive care as required."
The Overdosage section has also been changed to say that limited information from post marketing reports suggest that within a single respiratory syncytial virus season, adverse events after a sixth or greater dose of Synagis are similar in character and frequency to those after the initial five doses.
New Osteoporosis Treatment Available
The FDA has approved the first drug in a new class known as bone formation agents for the treatment of osteoporosis in postmenopausal women at high risk for a fracture. The drug, teriparatide (rDNA origin) injection (Forteo), manufactured by Eli Lilly and Company, is also indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.
Recombinant technology is used to manufacture teriparatide, which includes a portion of parathyroid hormone (PTH) that is thought to be responsible for stimulating the formation of new bone.
Approval was based on clinical trial data that demonstrated during an average of 19 months of treatment, teriparatide stimulated new bone formation, lowered the risk of vertebral (spinal) fractures, and increased bone mineral density compared with placebo in postmenopausal women with osteoporosis.
A risk-management program has been instituted to help assure the appropriate use of teriparatide. The drug labeling will display a black box warning about osteosarcoma findings in rats during preclinical testing. Teriparatide should be prescribed only to patients for whom potential benefits outweigh potential risks. It should not be prescribed to patients at increased risk for osteosarcoma, including patients with Paget's disease of bone or unexplained elevations of alkaline phosphatase, children or growing adults, or those who have had prior radiation therapy involving the skeleton.
Forteo is administered once daily by injection in the thigh or abdomen and is currently supplied in a disposable pen device that can be used for up to 28 days. It will be available in a 20-mcg dose and should be taken for no more than 24 months.
Isotretinoin Labeling Reflects New Warnings
Roche Laboratories is advising health care practitioners of several recent changes to the isotretinoin (Accutane) package insert. The changes involve the warning labeling, pediatric labeling, and the boxed contraindications and warnings section, and state the following:
* Aggressive and/or violent behaviors have been added to the list of events that Accutane may cause, based on safety reports.
* Caution should be used when prescribing Accutane to pediatric patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism. Patients may be at increased risk when participating in sports with repetitive impact. Furthermore, 29% of pediatric patients treated with Accutane in the studies developed back pain and 22% experienced arthralgias.
* Caution should be exercised when phenytoin and systemic corticosteroids are used with Accutane.
* Accutane should be given at recommended doses for no longer than the recommended duration.
* A new table has been added to labeling clarifying circumstances when pregnancy testing and Accutane Qualification Stickers are applicable.
For more information on Accutane, contact Roche at (800) 526-6367.
NEW BIRTH CONTROL OPTION
Low-Dose Contraceptive Approved
Norgestimate/ethinyl estradiol (ORTHO TRI-CYCLEN LO), received FDA approval for preventing pregnancy. The new product provides a daily, 25-mcg dose of estrogen for 21 days and three different doses of norgestimate (180 mcg daily/days 1 to 7; 215 mcg daily/days 8 to 14; and 250 mcg daily/days 15 to 21). According to Ortho-McNeil Pharmaceutical, norgestimate has a low rate of nuisance adverse effects such as weight gain, acne, and facial hair growth.
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ATTENTION DEFICIT TREATMENT
First New ADHD Drug in 30 Years
The FDA approved the first new drug in 30 years for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms. Atomoxetine (Strattera), a product of Eli Lilly and Company, has a different mechanism of action than stimulant-like drugs that have been used to treat ADHD. Atomoxetine will not be classified as a controlled substance since it does not appear to have a potential for abuse, the agency states.
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Clinical trials established the safety and effectiveness of atomoxetine in children, adolescents, and adults who met specific diagnostic criteria under the Diagnostic and Statistical Manual-IV. The studies demonstrated that atomoxetine significantly improves symptoms compared with placebo.
Side effects associated with atomoxetine include decreased appetite, upset stomach, nausea or vomiting, and tiredness. In addition to these, some of the most common side effects in adults were sleeping problems, dry mouth, dizziness, and sexual side effects.