Warnings Added to Valdecoxib Labeling
New warnings and information have been included in the product labeling of valdecoxib (Bextra) following reports of serious adverse effects. These have included life-threatening risks related to reactions such as Stevens Johnson Syndrome and anaphylactoid reactions. The labeling will also state that the drug is contraindicated in patients allergic to sulfa-containing compounds.
Pharmacia, the manufacturer of valdecoxib, has notified health care professionals of the reports and warnings by letter. Since the drug was first marketed in March 2002, rare cases of Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme have been reported. As these reactions can be life threatening, patients experiencing a rash after starting valdecoxib should discontinue the drug immediately.
To reach Pharmacia, call (800) 323-4202; to reach FDA's Medwatch program, call (800) FDA-1088.
Combination Diabetes Treatment Approved
Metaglip (glipizide and metformin HCl tablets) is now approved for use along with diet and exercise as initial drug therapy for people with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. Metaglip was also approved as a second-line therapy for patients with type 2 diabetes who are not currently taking either metformin or sulfonylureas with a regimen of diet and exercise, but whose blood sugar levels are not adequately controlled.
In clinical trials, Metaglip was shown to be more effective at lowering blood sugar levels than either glipizide or metformin used alone.
The most common side effects associated with Metaglip are diarrhea, nausea/vomiting, and abdominal pain. Symptoms of hypoglycemia may also occur with this drug. In rare cases Metaglip may cause lactic acidosis. The drug is contraindicated in patients who are age 80 or older, take medication for heart failure, are seriously dehydrated, have a serious infection, have kidney problems, or have had liver disease.
Metaglip is available in three dosage strengths (glipizide/metformin): 2.5-mg/250-mg tablets, 2.5-mg/500-mg tablets, and 5-mg/500-mg tablets.
Metaglip is a product of Bristol-Myers Squibb.
New Hepatitis C Treatment Available
The FDA has approved Roche's peginterferon alfa-2a (Pegasys) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha.
Peginterferon alfa-2a is a pegylated interferon that remains active longer and at a more constant level than interferon alpha. In three clinical trials, the drug was shown to be an effective treatment for patients with chronic hepatitis C.
Peginterferon alfa-2a is available as a premixed solution and is dosed as a subcutaneous injection once a week for a recommended duration of 48 weeks. The new drug is expected to be available immediately.
FAST H. PYLORI REGIMEN
First 7-Day H. pylori Treatment Approved
Rabeprazole sodium (Aciphex) is now approved in combination with antibiotics to treat Helicobacter pylori infection in 7 days. Current treatments for H. pylori infection take 10-14 days.
In combination with amoxicillin and clarithromycin (Biaxin) as a three-drug regimen, rabeprazole is indicated for the treatment of H. pylori infection and duodenal ulcer disease (active or history within the last 5 years) to eradicate H. pylori.
The 1-week treatment regimen was tested in a multicenter, double blind, placebo-controlled trial of 803 patients infected with H. pylori. Eighty-three percent of patients treated with rabeprazole, amoxicillin, and clarithromycin (RAC) taken twice daily were free of H. pylori after 7 days of therapy.
No adverse events unique to this drug combination were observed in clinical trials. The most frequently reported drug-related adverse events in RAC trials were diarrhea and taste perversion. For full prescribing information, consult product labeling.
Rabeprazole is a product of Eisai Inc. and is co-promoted by Janssen Pharmaceutica.