FDA Rounds

JUNE 02, 2007

New Agent for Smoking Cessation
Varenicline (Chantix; Pfizer) is the first new prescription medication for smoking cessation to be approved in over 10 years. By partially activating the nicotinic receptor, varenicline reduces the severity of craving and withdrawal symptoms. In 2 identically designed studies, persons who smoked about 21 cigarettes daily for an average of 25 years and who received a 12-week course of varenicline (1 mg twice daily) were nearly 4 times more likely to quit than those taking placebo and nearly twice as likely to quit as those taking 150 mg/day of bupropion (Wellbutrin). The most common side effects reported with varenicline include nausea, changes in dreaming, constipation, gas, and vomiting (www.pfizer.com).

First Rx for Pompe's Disease
A new biologic agent, alglucosidase alfa (Myozyme; Genzyme), has been approved as the first treatment ever for patients with Pompe's disease. Because 8 (3%) of the 280 patients who received alglucosidase in clinical studies or through expanded access experienced severe or significant hypersensitivity reactions, the product label includes a boxed warning, stating that "life-threatening anaphylactic reactions, including anaphylactic shock, have been observed in patients during infusion," and recommending that "appropriate medical support measures should be available when [alglucosidase] is administered." The recommended dosage is 20 mg/kg body weight, administered intravenously over about 4 hours, every 2 weeks (www.myozyme.com).

Minocycline ER for Acne
Extended-release minocycline HCl (Solodyn ER Tabs; Medicis) is now the only oral form of the medication approved for once-daily dosing to treat the inflammatory lesions of nonnodular, moderate-to-severe acne vulgaris in patients aged ≥12 years. Minocycline is lipid soluble and acts both in the skin and in the sebum. It will be available in 45-, 90-, and 135-mg tablets, with a recommended dosage of 1 mg/kg daily. The most frequently reported side effects are headache, fatigue, dizziness, and pruritus (www.medicis.com).

New Treatment for Myelodysplastic Syndromes
Decitabine (Dacogen; MGI Pharma) injection has been approved for the treatment of myelodysplastic syndromes. The recommended dose for the initial treatment cycle is 15 mg/m2 by continuous intravenous infusion for 3 hours and repeated every 8 hours for 3 days. Premedication with standard antiemetic therapy may be considered. The most frequently reported side effects include neutropenia, thrombocytopenia, anemia, pyrexia, fatigue, nausea, cough, petechiae, constipation, and diarrhea (www.mgipharma.com).

New Generic Drugs
? The first generic version of pravastatin (Pravachol; Bristol-Myers Squibb) has been approved and will be manufactured by TEVA Pharmaceuticals in 10-, 20-, and 40-mg tablets. The only other generic statin available in the United States is a version of lovastatin (eg, Advicor, Mevacor) that costs as little as $1/day (www.fda.gov).

? The first generic version of the capsule form of zidovudine (Retrovir; GlaxoSmithKline) has received FDA approval for HIV/AIDS and will be manufactured by Aurobinda Pharma (www.fda.gov).

New Regulations for Using Ephedrine Products
In accordance with the Combat Methamphetamine Epidemic Act of 2005, the FDA has announced new legal requirements for the sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine. The law involves monitoring the distribution and sale of products that can be used in the illicit production of methamphetamine, requiring that pseudoephedrine products be kept in locked cabinets or behind the counter. The new requirements include:

? Limiting the monthly amount an individual can purchase

? Presenting photo identification to purchase the medications

? Retailers keeping personal identification information about customers for at least 2 years.

This law goes into effect on September 30, 2006 (www.fda.gov/cder/newmethamphetamine.htm ).

Prevention of Influenza A and B
Zanamivir for inhalation (Relenza; GlaxoSmithKline)?previously approved for the treatment of influenza A and B in adults and children aged ≥5 years?has now been approved for prevention of these flu conditions (www.glk.com).

FDA Reevaluating Aspartame ? Cancer Link
The FDA is reevaluating a study of aspartame conducted by the European Ramazzini Foundation (ERF), which concluded that the sweetener causes cancer in rats and that current use should be reassessed. The FDA intends to complete its review of the ERF data and announce its conclusion as soon as possible. A recent review by the European Food Safety Authority determined that the link with cancer was not supported by available data and that there was no need to revise the Acceptable Daily Intake of aspartame (www.fda.gov/bbs/topics/NEWS/2006/NEW01369.html ).

Rx Warnings
? The FDA and GlaxoSmithKline issued changes to the Clinical Worsening and Suicide Risk subsection of the Warnings section in the prescribing information for paroxetine (Paxil, Paxil CR) that apply to adults, particularly younger ones, who were shown in a recent meta-analysis to experience a higher frequency of suicidal behavior after treatment with paroxetine compared with placebo (www.fda.gov/medwatch/safety/2006/safety06.htm#paxil ).

? The FDA and IVAX Pharmaceuticals have issued a recall of the Goldline brand of Extra Strength Genapap 500 mg (acetaminophen) caplets and tablets because of a labeling error of dosage levels (www.fda.gov/medwatch/safety/2006/safety06.htm#Goldline ).

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