New Indication for Asthma Med
The FDA has approved Merck's montelukast (Singulair) for the prevention of exercise-induced bronchoconstriction (EIB, also called exercise-induced asthma) in patients 15 years of age and older. Montelukast is the first and only oral asthma medication approved for this use, according to Merck. The medication was previously approved for the prevention and chronic treatment of asthma in adults and pediatric patients 12 years of age and older.
In clinical studies of montelukast, one 10 mg tablet of the medication prevented exercise-induced asthma attacks when taken 2 hours before exercise.
Some patients were protected from EIB at 8.5 and 24 hours after administration of montelukast; other patients were not.
Patients already taking one tablet of montelukast daily for another indication, including chronic asthma, should not take an additional dose to prevent EIB.
Montelukast is not indicated for relief of acute asthma attacks. Consult product labeling for detailed prescribing instructions.
New Schedule for Combination Hep Vaccine
An accelerated dosing schedule for hepatitis A inactivated and hepatitis B (recombinant) vaccine (Twinrix) has been approved by the FDA. The new schedule allows administration of three doses within 30 days (given at 0, 7, and 21 to 30 days), followed by a booster dose at 1 year. Twinrix is a product of GlaxoSmithKline Biologicals. It is indicated for the active immunization of individuals 18 years of age and older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B.
The accelerated dosing regimen is expected to help emergency care first responders, people preparing to travel to high-risk areas on short notice, and people with risk factors for hepatitis such as HIV and sexually transmitted diseases.
The previous primary immunization dosing regimen required three doses of the vaccine to be administered during a 6-month period.
Approval of the new dosing schedule was based on a review of data showing that immune responses at 1 year were similar for those who completed the vaccination series on an accelerated schedule versus those who received separate vaccinations with a monovalent hepatitis A vaccine (Havrix) and hepatitis B vaccine (Engerix-B).
Adverse events included pain/erythema at the injection site, headache, and fatigue.
First Vaccine for Humans Against "Bird Flu"
The first approval in the United States of a vaccine for humans against the H5N1 influenza virus has been announced by the FDA. The vaccine is intended for immunizing people 18 through 64 years of age who could be at increased risk of exposure to the H5N1 influenza virus.
The vaccine could be used if the current H5N1 avian virus were to develop the ability to spread from human to human, resulting in the rapid spread of the disease. Should such a pandemic develop, the vaccine may provide early, limited protection in the months before a vaccine tailored to the pandemic strain of the virus could be developed.
The vaccine consists of two intramuscular injections given about 1 month apart. The vaccine will not be sold commercially and will be kept in the U.S. Strategic National Stockpile for distribution by public health officials.
Generic Ambien (Zolpidem Tartrate) Now Available
The FDA approved the first generic version of zolpidem tartrate (Ambien) immediate-release tablets, which are approved for the short-term treatment of insomnia. The tablets, in formulations of 5 mg and 10 mg, are manufactured by multiple U.S. generic companies.
Like Ambien, all formulations of the generic version will include language on the medications' labeling concerning potential risks, including severe allergic reactions and complex sleep-related behaviors, which can include sleep driving. Sleep driving is driving while not fully awake after ingesting the medication, with no memory of the event.