FDA宣佈逐步淘汰以CFC為推動劑的氣喘和COPD吸入器

作者：Emma Hitt, PhD  
出處：WebMD醫學新聞

　　April 16, 2010 — 根據臭氧層破壞物質之規範，美國食品藥物管理局(FDA)宣佈，7個現有以氟氯碳化物(chlorofluorocarbons，CFCs)作為推動劑的氣喘和慢性阻塞性肺部疾病(chronic obstructive pulmonary disease，COPD)定量吸入器即將下市。
　　
　　這個逐步淘汰行動是遵守「消耗臭氧氣層物質蒙特婁議定書(Montreal Protocol on Substances that Deplete the Ozone Layer)」，這些藥物將改用氫氟烷(hydrofluoroalkanes)取代CFC相關製劑。
　　
　　【受影響的產品】
　　受影響的產品與其淘汰日期如下：
　　* nedocromil (商品名Tilade Inhaler, King Pharmaceuticals藥廠)，2010年6月14日。
　　* metaproterenol (商品名Alupent Inhalation Aerosol, Boehringer Ingelheim藥廠)，2010年6月14日。
　　* triamcinolone (商品名Azmacort Inhalation Aerosol, Abbott Laboratories藥廠)，2010年12月31日。
　　* cromolyn (商品名Intal Inhaler, King Pharmaceuticals藥廠)，2010年12月31日。
　　* flunisolide (商品名Aerobid Inhaler System, Forest Laboratories藥廠)，2011年6月30日。
　　* albuterol與ipratropium複方(商品名Combivent Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals藥廠)，2013年12月31日。
　　* pirbuterol (商品名Maxair Autohaler, Graceway Pharmaceuticals藥廠)，2013年12月31日。
　　
　　根據FDA新聞稿，美國已經禁止一般消費用噴霧型產品使用CFCs達數十年，且自1996年1月1日開始禁止在美國生產CFCs，除了固定劑量吸入器之外。
　　
　　FDA公共事務辦公室發言人Erica V. Jefferson接受Medscape Medical News訪問時表示，如同多數國家，美國簽署了這份協議，且承諾在一特定日期之後，製造與銷售含有CFC物質的產品將視為非法，根據此協議的部分內容，多數CFC吸入器已經逐步淘汰。
　　
　　根據Jefferson小姐表示，並沒有特定的監測計畫，處方者不會有懲罰，她向Medscape Medical News表示，不過，FDA已經和藥廠、健康照護專業人士與病患團體合作，提醒他們這些含有CFC的產品在過渡期之後將不再銷售或供應。
　　
　　Jefferson小姐解釋，許多製造CFC吸入器的公司已經停止生產過渡清單上的一些產品，包括Tilade、Alupent、Azmacort和Intal，其他3個產品(Aerobid、Maxair和Combivent) 在2011至2013年這段過渡期間仍然有供應，但是，並不清楚存貨數量。
　　
　　【現有的替代選項】
　　Jefferson小姐表示，醫師應和他們的病患合作，以確認哪個替代產品對控制病患病情最佳、哪些對病患的生活型態有幫助。
　　
　　美國過敏氣喘與免疫學院研究員、Capital 過敏與呼吸道疾病中心的Bradley E. Chipps醫師表示，這個逐步淘汰行動並未顯著改變開業肺部專科醫師的臨床實務，不過，他指出，病患比較不願意遵守，因為不含CFC的產品比較貴，他向Medscape Medical News表示，重要的是，氫氟烷吸入器會造成「鼻塞」，而CFC吸入器沒有這個問題。
　　
　　FDA網站可連結下列更多資訊：
　　使用CFCs的7個吸入器被逐漸淘汰
　　逐漸淘汰flunisolide、triamcinolone、metaproterenol、pirbuterol、albuterol與ipratropium複方，cromolyn和nedocromil等成分的CFC定量吸入器。
　　定量吸入器清潔空氣法之資訊
　　不使用氟氯碳化合物之氣喘與慢性阻塞性肺部疾病的藥物治療


FDA Announces Phase Out of CFC-Based Asthma and COPD Inhalers

By Emma Hitt, PhD
Medscape Medical News

April 16, 2010 — In compliance with a rule about ozone-depleting substances, the US Food and Drug Administration (FDA) has announced that 7 available asthma and chronic obstructive pulmonary disease (COPD) metered-dose inhalers that use chlorofluorocarbons (CFCs) as propellants are being removed from the marketplace.

The phase out is to comply with the Montreal Protocol on Substances that Deplete the Ozone Layer. Alternative medications that contain hydrofluoroalkanes are available to substitute for the CFC-based products.

Affected Products

The affected products and their phase-out dates are as follows:

nedocromil (Tilade Inhaler, King Pharmaceuticals), June 14, 2010
metaproterenol (Alupent Inhalation Aerosol, Boehringer Ingelheim), June 14, 2010
triamcinolone (Azmacort Inhalation Aerosol, Abbott Laboratories), December 31, 2010
cromolyn (Intal Inhaler, King Pharmaceuticals), December 31, 2010
flunisolide (Aerobid Inhaler System, Forest Laboratories), June 30, 2011
albuterol and ipratropium in combination (Combivent Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals), December 31, 2013
pirbuterol (Maxair Autohaler, Graceway Pharmaceuticals), December 31, 2013
According to the FDA press release, the United States has banned the general use of CFCs in consumer aerosols for decades and eliminated the production of CFCs in the United States as of January 1, 1996, except for certain limited uses, such as metered-dose inhalers.

"Like most countries, the US signed this agreement and committed to making it illegal to make or sell CFC-containing substances after a certain date," said Erica V. Jefferson, a spokesperson with the FDA Office of Public Affairs in a conversation with Medscape Medical News. "Most CFC inhalers have already been phased out as part of this agreement," she added.

According to Ms. Jefferson, there are no special monitoring programs, and there will be no penalties for prescribers. "However, [the] FDA has been working with manufacturers, healthcare professionals, and patient groups to notify them that these CFC-containing products will no longer be available for sale or distribution after the transition dates," she told Medscape Medical News.

Many companies that make CFC inhalers have already stopped manufacturing some of the products on the transition list. These include Tilade, Alupent, Azmacort, and Intal. The remaining 3 products (Aerobid, Maxair, and Combivent) being transitioned between 2011 and 2013 are still available, but the amount of inventory remaining is unknown, Ms. Jefferson explained.

Available Alternatives

"Physicians should work with their patients to determine which alternative product or products will work best for their patients in terms of managing their disease, and which will work for their patients' lifestyle," Ms. Jefferson said.

Bradley E. Chipps, MD, from the Capital Allergy Respiratory Disease Center and a fellow of the American Academy of Allergy Asthma and Immunology, said that this phase out will not significantly change clinical practice for practicing pulmonary specialists. However, he added, patients are less likely to be adherent because of higher costs for CFC-free products. "Importantly, [hydrofluoroalkane] inhalers can become 'stuffed up,' whereas the CFC inhalers did not have this problem," he told Medscape Medical News.

More information is available on the FDA Web site:

Seven Inhalers That Use CFCs Being Phased Out

Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil

Metered-Dose Inhalers Clean Air Act Information

Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons