Trumm Drug

May 2010 Drug News

FDA announces phase-out of CFC inhalers
FDA announced today that seven metered-dose inhalers (MDIs) containing chlorofluorocarbons (CFCs) will be phased out of use in the United States. The agency took this action in accordance with U.S. obligations under the Montreal Protocol on Substances That Deplete the Ozone Layer, which took effect in 1989. The inhalers use CFC, which depletes the ozone, as a propellant. There are alternative medications available that do not contain CFCs.

The following seven products, used to treat asthma and chronic obstructive pulmonary disorder (COPD), will be phased out of the U.S. market by the accompanying dates:

• Tilade Inhaler (nedocromil – King), June 14, 2010
• Alupent Inhalation Aerosol (metaproterenol – Boehringer Ingelheim), June 14, 2010
• Azmacort Inhalation Aerosol (triamcinolone – Abbott), December 31, 2010
• Aerobid Inhaler System (flunisolide – Forest), June 30, 2011
• Combivent Inhalation Aerosol (albuterol/ipratropium – Boehringer Ingelheim), December 31, 2013
• Maxair Autohaler (pirbuterol – Graceway), December 31, 2013

Patients using these inhalers should speak to a health professional about switching to one of the several alternative treatments currently available. Until then, patients should continue using their current inhaler medication.

“During this transition, FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD,” said Badrul Chowdhury, MD, PhD, Director of the Division of Pulmonary, Allergy, and Rheumatology Products of the FDA Center for Drug Evaluation and Research, in a news release. “We are currently working with professional societies and patient organizations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them.”

Information for consumers on the phase-out of these MDIs is available on the FDA website at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm207864.htm. This page includes a link to a list of FDA-approved inhalers that do not contain CFCs. Some non-CFC inhalers use hydrofluoroalkane (HFA), while other dry powder inhalers do not contain any propellant at all.

Aetna Slapped by Medicare
Aetna is being barred by the Centers for Medicare & Medicaid Services from marketing to and enrolling new beneficiaries in its standalone and Medicare Advantage Part D plans effective April 21. The ban “will remain in effect until Aetna demonstrates to CMS that it has corrected its deficiencies and they are not likely to recur,” CMS said. “Medicare’s actions should not impact the approximately one million enrollees in the Aetna plans across the country.”

CMS said one of the reasons it was imposing an “intermediate sanction notice” was because Aetna did not ensure that beneficiaries were able to continue to receive drugs they had been receiving in 2009 that were not on the plans’ formularies in 2010.

First generics of two hypertension drugs approved
Last month, FDA approved the first generic versions of two drugs used for the treatment of hypertension. Losartan potassium tablets and combination losartan potassium/hydrochlorothiazide tablets are generic versions of Merck“s Cozaar and Hyzaar, respectively. Both generics are manufactured by Teva Pharmaceuticals.

Both generic losartan products will carry the same safety warnings as their brand counterparts. These include a boxed warning against the use of these products during the second and third trimesters of pregnancy. Losartan tablets will be available in 25 mg, 50 mg, and 100 mg strengths, while losartan/hydrochlorothiazide tablets will be available in 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg strengths.

FDA also approved applications from several companies for the 100 mg/12.5 mg dosage only of losartan/hydrochlorothiazide. These companies include Mylan Pharmaceuticals, Roxane Laboratories, and Torrent Pharmaceuticals.

Pseudoephedrine: OTC or Rx?
In an effort to reduce the use of pseudoephedrine in the production of illicit methamphetamine, Congress is considering legislation to change the status of pseudoephedrine-containing products from over the counter to prescription. Oregon has made such a switch and Mississippi will require prescriptions starting July 1.

Medical Misinformation Can Spread Quickly Via ‘Tweets’: Research
Medical misinformation can spread quickly on Twitter, though social networks also offer potential for sharing vital and correct health information, a study published in the American Journal of Infection Control finds. Of 52,000 Twitter updates studied, about 700 tweets included incorrect information about antibiotics, including misunderstandings and bad advice about how they should be used or evidence of misuse. HealthDay

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