Low-Dose OC with Iron Approved
The FDA has approved a 24-day active hormonal regimen of norethindrone acetate-ethinyl estradiol 0.02 mg/1 mg tablets (Loestrin 24 Fe) for oral contraception (OC) in women. According to Warner Chilcott, Inc., Loestrin 24 Fe contains the lowest level of estrogen allowed by the FDA (20 mcg per pill). The new OC is 99% effective at preventing pregnancy when taken according to instructions.
With Loestrin 24 Fe, a woman's period starts later and bleeding is lighter, lasting on average less than 3 days. Loestrin 24 Fe is taken as 24 "active" pills instead of the typical 21. The 3 additional days of hormones result in less hormone buildup, so there is less menstrual flow. The remaining pills are iron supplements.
Premier Generic Pravastatin Formulation
A first-time generic formulation of pravastatin sodium 10, 20, and 40 mg tablets has been FDA approved for the treatment of primary hypercholesterolemia and mixed dyslipidemia, elevated serum triglycerides, and primary dysbetalipoproteinemia in patients who do not respond adequately to dietary modifications. The new generic pravastatin is a product of Teva Pharmaceuticals.
In patients with hypercholesterolemia, but without clinically evident coronary heart disease, pravastatin therapy is used to reduce the risks of heart attack, myocardial revascularization procedures, and cardiovascular mortality, and to slow down the progression of atherosclerosis and reduce the risk of coronary death, stroke, and transient ischemic attacks in patients with clinically evident disease.
Pravastatin is also approved as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolemia in children and adolescents aged 8 years and over.
FDA Issues Public Advisory On Three Asthma Drugs
The FDA has requested that the manufacturers of fluticasone propionate and salmeterol (Advair Diskus), formoterol fumarate (Foradil Aerolizer), and salmeterol xinafoate (Serevent Diskus) update their existing product labels with new warnings and a medication guide for patients that state these medicines may increase the chance of severe asthma episodes and death when these episodes occur. All of the products contain long-acting beta 2-adrenergic agonists (LABAs).
The recommendations about using LABA medicines for asthma include:
* LABAs should not be the first medicine used to treat asthma; they should be added to the asthma treatment plan only if other medications do not control asthma.
* Patients should not stop using their LABA or other asthma medicine without discussing it with their healthcare provider.
* LABAs should not be used to treat wheezing that is worsening. If wheezing worsens while using a LABA, the clinician should be contacted immediately.
* LABAs do not relieve sudden wheezing; a short-acting bronchodilator should be on hand to treat sudden wheezing.
First Smoking Cessation Drug in 10 Years
Pfizer's varenicline tartrate (Chantix) has been approved to help cigarette smokers quit. It is the first new prescription drug for smoking cessation to be approved in 10 years. Varenicline tartrate works by acting at sites in the brain affected by nicotine, and may provide some nicotine effects to ease withdrawal symptoms. It also blocks the effects of nicotine from cigarettes if patients resume smoking so that the sense of satisfaction associated with smoking is diminished.
Varenicline tartrate demonstrated effectiveness in six clinical trials that included more than 3,600 chronic smokers and was shown to be superior to placebo in helping people quit smoking. These smokers had averaged 21 cigarettes a day for approximately 25 years.
The approved course of treatment for varenicline tartrate is 12 weeks. Patients who successfully quit smoking during treatment may continue with an additional 12 weeks of treatment to increase the likelihood of long-term smoking cessation.
Section Description
Medication Update alerts readers to new drug approvals and other timely drug information. Healthcare providers should not make clinical decisions from these announcements, as they are not comprehensive.