FDA Warns Consumers Not to Use Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)

* Lot number 9G04, NDC # 49502-697-29
* Lot number 9FD8, NDC # 49502-697-61
* Lot number 9FD9, NDC # 49502-697-61
* Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)

* Lot number F09089, NDC # 49502-685-31
* Lot number C09119, NDC # 49502-685-62
* Lot number C09120, NDC # 49502-685-62

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

The FDA is asking for the public's help in reporting any information regarding the stolen Dey products to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

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Asthma Sufferers Breathe Easier as Walmart Announces $9 Environmentally Sustainable Inhaler

/PRNewswire-FirstCall/ -- As part of its continued commitment to provide accessible, affordable medications to those who need it most, Walmart today announced it will carry an environmentally friendly albuterol rescue inhaler starting at $9, the lowest-priced inhaler on the market. The ReliOn(R) Ventolin HFA inhalers, sold exclusively at Walmart*, will ease the transition as asthma sufferers are forced to replace their CFC-powered inhalers with new HFA inhalers in the new year to comply with an FDA mandate.

"While some HFA inhalers may sell for as much as $60 for certain brands, our $9 ReliOn Ventolin HFA inhaler will ease the financial burden for sufferers of asthma who should not go without these life-saving medications," said Sandy Kinsey, Walmart's divisional merchandise manager for pharmacy. "As an advocate for our customers, we're committed to ensuring they have access to affordable medicine they cannot live without."

According to the 2007 National Institutes of Health (NIH) asthma treatment guidelines, overuse of albuterol is a sign of uncontrolled asthma. With 60 metered inhalations, the ReliOn Ventolin HFA inhaler helps both patients and health care professionals monitor and track usage via the dose counter to identify overuse of albuterol. Additionally, it helps patients track how many puffs remain in their inhaler so they do not run out of their rescue medication when they need it most.

Walmart offers other affordable medications* for those suffering from the disease, including:

Albuterol 2mg tab $4 for 90 tablets $10 for 270 tablets
Albuterol 4mg tab $4 for 60 tablets $10 for 180 tablets
Albuterol 2mg/5ml syrup $4 for 120ml $10 for 360ml


For further information about Walmart's affordable prescription program, customers can visit http://www.walmart.com/pharmacy or discuss the program with their local Walmart, Neighborhood Market or Sam's Club pharmacist.

* Products and pharmacies are not available in North Dakota

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FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now

The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.

CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.

Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.

"Concern about the environment stimulated the need to phase out CFCs," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers."

Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with asthma and chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. Patients use albuterol inhalers to deliver medicine directly into the lungs.

The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.

Manufacturers have been increasing production of HFA albuterol inhalers, so an adequate supply is available now.

HFA-propelled albuterol inhalers may taste and feel different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler. Patients must also prime and clean HFA-propelled albuterol inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and patients should read and understand the instructions first before using the inhaler.

The phaseout of CFC-propelled inhalers is the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of ozone depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed or sold in the United States after Dec. 31, 2008.