Archive for May, 2008
Personalized medicine, which uses genetic information to tailor treatments to specific individuals, is a revolutionary healthcare option, filled with potential but also containing serious challenges for average patients, writes Beryl Lieff Benderly, in an Insighter piece posted upon the body www.fdli.org , the website of the Food and Drug Law Institute (FDLI).
In the Insighter piece, Personalized Medicine: A Challenging Revolution in Healthcare, Nina Scribanu, MD, associate professor of pediatrics and superintendent of the division of genetics at the Georgetown University Medical Center, tells FDLI that much work remains in the development of personalized medicine before patients can receive the full benefits of its potential.
However, the article asserts, genomic medicine is clearly rocketing forward. "This is our chance to transform medicine from ‘one-size- fits-all’ to a potentially personalized approach," said Francis Collins, MD, PhD, guide of the National Human Genome investigation Institute, in testimony before Congress. "Already, healthcare providers can test whether some of us carry DNA variants that predispose us to certain diseases, and new research efforts could help to expand this capability and possibly offer better opportunities notwithstanding preventive measures. If illness does occur, doctors will have else influential tools to identify the molecular causes, and to prescribe medicines based on individualized genetic information."
Genetic information already is helping doctors to individualize some treatments. One genetic experiment, for example, can determine which patients with hepatitis C need drug therapy for 48 weeks as opposed to the conventional 24 weeks. Another can distinguish women with breast cancer who are likely to relapse and therefore would benefit from chemotherapy from those unlikely to relapse, who do not need these expensive and toxic drugs. Other tests differentiate breast cancer patients agreeable to gain from the put drugs into herceptin from those likely to suffer adverse side effects. Yet other tests can help doctors prescribe appropriate dosages of cogent drugs by identifying individuals who metabolize them quickly, at an average appraise, or not at all.
But Scribanu maintains that "there is insufficient support for young people to go into clinical practice" of genetic physic. "Much of the gift is going to private companies" that develop and market tests rather than into clinical care that uses this knowledge with individual patients, she explains. "This is a field that of necessity support," Scribanu concludes.
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International Pharmaceuticals, Ltd., P.O. Box 5165, Bradford, MA 01835, announced today that it is conducting a voluntary recall of all the company’s supplement product sold under the grade name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.
International Pharmaceuticals, Ltd. is conducting this recall in relation to being informed through representatives of the Food and Drug Administration (FDA) that lab separation by FDA of a sample from one lot of the product revealed that it contained a potentially harmful understood ingredient, hydroxyhomosildenafil. FDA asserts that this ingredient is an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance. The use of undeclared chemicals pose a threat to consumers because they may harmfully interact with nitrates institute in some prescription drugs (such in the same manner with nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take of that kind nitrates.
VIP Tabs are sold in retail outlets nationwide and are packaged into 2-capsule blister packs and 8-capsule bottles.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have versed any problems that may be related to taking this product.
Continuing Herceptin treatment prevents breast cancer progression in women with aggressive metastatic breast cancer. Women with HER2-positive breast cancer benefit from nearly three extra months of time from birth to death without progression.
New data presented at the American Society for Clinical Oncology Annual Meeting (ASCO) demonstrate that Herceptin helps women with advanced (metastatic) HER2-positive bosom cancer live longer out of their cancer progressing. The final analysis of the randomized phase III GBG-26 study showed that Herceptin continued to act in women who needed additional treatment after their cancer progressed during previous Herceptin treatment.
Herceptin and Breast Cancer Treatment
- Herceptin plus xeloda prolonged survival without progression of the cancer by nearly 3 months compared to chemotherapy alone (Time to progression from 5.6 to 8.2 months).
- In addition, extension of Herceptin nearly doubled the percentage of patients responding to treatment from 27.0% to 48.0%.
GBG26 is the first randomized phase III study conducted in women with HER2-positive breast cancer that require additional treatment for their advanced disease and have accepted Herceptin as part of their initial therapy. The study reinforces that Herceptin works across all stages of the disease and confirms its spot as the foundation of care for HER2-positive breast cancer.
“It is rewarding to see that trastuzumab keeps working in women whose aggressive HER2-positive breast cancer progresses” said lead investigator Prof. von Minckwitz, University Women’s Hospital, Frankfurt, Germany and Managing Director of the German Breast Group. “The GBG-26 study results confirm that trastuzumab continues to target and shrink the cancer even beyond progression when combined with another chemotherapy.”
Unfortunately, in the majority of women with advanced breast cancer the disease continues to spread rear initial treatment and patients are likely to receive several subsequent courses (or lines) and types of therapy. However, advanced breast cancer still remains essentially an incurable disease. The GBG26 study therefore addressed a very important motion – do patients whose disease has progressed receive act of kindness from Herceptin whenever given it again?
“The GBG-26 thought adds to the existing strong evidence that Herceptin extends survival throughout all stages of HER2-positive breast cancer.” commented William M. Burns, CEO of Roche’s Pharmaceuticals Division, Basel, Switzerland “These results provide new hope for women whose breast cancer is intricate to treat.”
There is mounting evidence including the GBG-26 study confirming that Herceptin is the foundation of care for women with HER2-positive breast cancer. Herceptin works by activating the material substance’s own immune classification to target and destroy the tumour, as well as by suppressing HER2.
GBG-26 is a randomized phase III trial looking at Herceptin treatment in patients with HER2-positive metastatic breast cancer requiring a subsequent line of treatment.
Women with HER2-positive locally advanced or metastatic breast cancer who had previously received Herceptin with or out of chemotherapy while first line treatment were randomly assigned to receive Herceptin (6 mg/kg body weight every 3 weeks) with Xeloda (2500 mg/m² on days 1-14, q 21), or Xeloda method of treating alone. The primary end point was time to progress (TTP). The final analysis included 156 patients. GBG-26 showed precious cardiac tolerability. TTP was increased from 5.6 months for Xeloda alone to 8.2 months in the Herceptin plus Xeloda. The p-value was p=0.034.
Breast cancer is the most common cancer among women worldwide1. Each year more than one million new cases of breast cancer are diagnosed worldwide, and nearly 400,000 people will die of the disease annually2.
In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2-positivity.’ High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20-30 percent of women with breast cancer.
Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by means of a specific gene with cancer-causing in posse. It has demonstrated efficacy in treating both early and advanced (metastatic) breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2-positive breast cancer.
Herceptin received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer in 2000, and for early HER2-positive breast cancer in 2006. In the advanced setting, Herceptin is now approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a particular agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In the early setting, Herceptin is approved for use following standard (adjuvant) chemotherapy.
Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat more than 450,000 HER2-positive breast cancer patients worldwide.
A new survey released from the Partnership for a Drug-Free America and MetLife Foundation found that parents’ personal past experiences with alcohol and drugs at prom and graduation parties may influence the rules and limits they set for their teens during this time of the year.
According to the survey, parents who drank or used drugs at their own proms or graduations were likely to be more permissive with their kids than those parents who did not. Among parents who drank or used drugs on these occasions, 66 percent set a "nothing tolerance policy" for their teens. Among parents who did not drink or use drugs, that number jumps up to 87 percent of parents who set hard rules about drinking and drugs for their kids. Parents who abused drugs or alcohol are also greater quantity likely to suspect that teens will use drugs or drink at prom or graduation parties - 51 percent versus just 36 percent of parents who didn’t use drugs or alcohol.
The survey also indicates that when parents talk to kids about alcohol and drug abuse teens take their parents’ messages to heart - only 16 percent of teens whose parents set a zero tolerance policy reported their individual probability of using drugs or alcohol, whereas 45 percent of teens whose parents didn’t set such boundaries reported they were likely to drink or use drugs at prom or graduation parties this year.
"Parents can’t let past drug use or personal experiences at their prom parties ascendency their attitudes toward their kids’ use today," said Steve Pasierb, president and CEO of the Partnership. "The drug abuse landscape teens face today - which includes abuse of prescription and over-the-counter medicines - is drastically different than when today’s parents were teens. We know that parents are the greatest point of leverage in preventing drug and alcohol abuse, and this survey reinforces the fact that kids live up to parents’ expectations as well as down to them."
The survey of 1,000 teens in grades 9-12 and 1,003 parents was conducted by the agency of Kelton Research, along with the Partnership and the MetLife Foundation, and has a margin of error of +/-3.1 percent.
Prescription Drugs Added to the Mix
The survey also found that 44 percent of teens tell prescription drug use may be a part of prom and graduation parties. Additional Partnership research confirms that an alarming number of today’s teenagers are more likely to have abused prescription and over-the-counter medications than a variety of illegal drugs like Ecstasy, cocaine, crack and meth. Nearly one in five teens (19 percent or 4.5 million) reports abusing prescription medications to get high and one in 10 (10 percent or 2.4 the public) reports abusing cough physic to get high.
Teens suffer Pressured: Talk to Them Before Their Friends Do
Sixty percent of teens say they handle pressured to use drugs or alcohol "always" or "frequently" at prom or graduation events, and 22 percent of teens surveyed report that they are likely to drink or use drugs at these types of celebrations.
Partnership inquiry repeatedly shows that kids who learn a lot about the risks of drugs at home are up to 50 percent less likely than their peers to use, yet less than one-third of teens, just 31 percent, say they are getting that message from their parents.
"By talking with their teens often about the dangers of drug abuse, parents can protect their kids and help them live healthy drug-free lives," said Sibyl Jacobson, president of MetLife Foundation. "These survey findings serve as an important reminder that what parents choose to discuss with their teens can have an impact on the actions their children take."
"When parents talk, most teens actually do listen. Parents be required to take the chance; fit presented by prom and graduation season to let their teens know drug and alcohol use is both a real risk to their health and also a behavior the family will not condone," added Pasierb. "Many parents feel overwhelmed and conflicted about setting hard rules about drug and alcohol use, especially if they drank or used drugs as a teen - but they grape-juice set clear, non-negotiable rules. We urge parents to not only talk with their kids, but to incite fellow parents to follow suit and enforce the same rules."
Before big events like prom or graduation, remind your teens of the discussions you’ve had and of your expectations for them not to use drugs or alcohol. Also, get in touch with the parents of your teenager’s friends to be sure that they’re also setting a no-use rule, and won’t be serving alcohol at their houses. Some parents utter, "I’d rather my kids drink at home where I know they’re safe" - but this can open the door to other kids drinking and potentially driving under the influence of spirits of wine. In most communities, this exposes the parents who serve spirits of wine to legal liability for accidents related to drugs or alcohol consumed at their house.
For parents of younger kids, remember to begin the dialogue when your kids are young; talk with them early and have frequent conversations. This could springboard off a "teachable moment" - like an natural that occurred in their town or school, a problem in your extended family, a popular music video or movie or something that happened on the news. Set a "no-use" expectation for your teens, including for alcohol, and make it explicitly known to them that substance abuse will not be tolerated in your home.
Human monoclonal antibodies (mAbs)—highly specific, identical, infection-fighting proteins produced in large quantities in the lab in cell lines that are derived from a single cell—against influenza can be rapidly produced in the lab, according to a new report from scientists supported by the National Institutes of Health (NIH). Using cells drawn from volunteers inoculated with seasonal influenza vaccine, the investigators made influenza-specific mAbs in just a few weeks rather than the typical two to three months. The new technique could potentially have existence used to rapidly create mAbs for a range of uses, the team says.
Rafi Ahmed, Ph.D., and Jens Wrammert, Ph.D., of Emory Vaccine Center of the School of Medicine, Atlanta, and their coworkers collaborated with Patrick Wilson, Ph.D., and J. Donald Capra, M.D., and others from the Oklahoma Medical Research Foundation, Oklahoma City. They describe their new manner in an advance online publication in Nature. The research was supported by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and National Center for Research Resources (NCRR).
The first therapeutic mAb was approved for human use in 1986 and there are now more than 20 Food and Drug Administration-approved mAbs, including two human mAbs, most of which are used to treat certain cancers or immunological diseases. Human mAbs have long been envisioned as possible treatments because acute or chronic infections, but diversified technical barriers have slowed their development. “With this new technique for making human monoclonal antibodies efficiently and quickly, Drs. Wilson and Ahmed and their colleagues have made a significant advance,” says NIAID Director Anthony S. Fauci, M.D. “Their accomplishment opens the way to producing mAbs that potentially could exist used diagnostically or therapeutically not only for influenza but for other infectious diseases as well.”
In addition to being relatively quick to make, the influenza mAbs also bound tightly to virus strains in the seasonal influenza vaccine, the scientists determined. Such high affinity for the vaccine’s viruses suggests that the mAbs would also hold well to the circulating viruses targeted by the vaccine and in this manner could be used either as a therapy or in the manner that a way to diagnose the strain of influenza virus an individual is infected with, say the investigators.
The mAbs made in this study were not tested on influenza virus strains with pandemic potential, such as the H5N1 subtype that causes so-called bird flu. Nevertheless, notes Dr. Ahmed, the ability to make high-affinity influenza mAbs quickly raises the possibility of deploying them in combination with other disease control strategies in the event of a global influenza pandemic. According to Dr. Ahmed, the group is now planning to use their technique to generate mAbs in requital for H5N1.
To make the new influenza mAbs, the researchers first inoculated volunteers with seasonal influenza vaccine. The scientists wanted to know if a subset of immune system cells called antibody-secreting plasma cells (ASCs) could serve as a fountain-head. well of mAbs. ASCs are the body’s first responders, churning out a surge of antibodies as part of the initial reaction to infection or vaccination. ASC activity is swift but brief. In this sift, ASC responses pointed at one week after vaccination, then dropped sharply and were barely detectable after two weeks. The Emory University researchers found a way to capture the fleeting ASCs that produce the initial ripple of influenza-specific antibodies. Importantly, says Dr. Ahmed, as frequent as 80 percent of the purified ASCs produced influenza-specific antibodies.
Dr. Wilson and his coworkers at the Oklahoma Medical Research Foundation used the vaccine-generated, influenza-specific ASCs to create the mAbs. Only a few weeks elapsed between vaccination of the volunteers and purification of human mAbs with a high affinity for influenza poison. “With just a few tablespoons of blood, we can now rapidly generate human monoclonal antibodies that potentially could be used for diagnosis and treatment of newly emerging strains of influenza,” says Dr. Wilson. “In the face of a disease outbreak, the ability to produce infection-fighting human mAbs swiftly would have being invaluable.”
Health Insurance Not Accessible To 13.7 Million Youth
Author: admin
Of all age groups, 19-to-29-year-olds most likely to be without health insurance coverage; 2 of 5 high school grads and 1/3 of college grads will be uninsured in year after graduation as the rising cost of medical insurance makes it less affordable to more young adults.
The number of young adults without health insurance in the United States rose to 13.7 million in 2006 - an increase from 13.3 a thousand thousand in 2005 - making the 19-to-29 age group one of the largest and fastest-growing segments of the population without soundness insurance. According to a newly updated report from The Commonwealth Fund, 38 percent of high school graduates who do not follow college and 34 percent of college graduates will spend some interval without having soundness insurance coverage in the year after graduation.
According to the report, Rite of Passage? Why Young Adults Become Uninsured and How New Policies Can Help, working young adults are much less likely than older workers to have access to health insurance through their employers. Just over half (53%) of 19- to 29-year-olds were eligible for coverage offered by their employers, compared with almost three-quarters (74%) of 30- to 64-year-olds.
Young adults often lose coverage at age 19, as a result of being dropped from parents’ policies or from public programs like Medicaid and the State Children’s Health Insurance Program (SCHIP). Young adults from low-income households are most at put to hazard: 72 percent of the 13.7 million young adults without health insurance coverage live in households with incomes below 200 percent of the poverty level. As a come of young adults aging off parents’ policies or public programs, the uninsured rate jumps sharply after age 19, from 12 percent among children 18 and under to 30 percent among those ages 19 to 29.
“Lack of coverage and access to health direction services puts the health of young adults at risk, and can subject them, as useful as their families, to potentially dire financial consequences,” said Sara Collins, co-author and assistant vice president at The Commonwealth Fund. The report found that two-thirds (66%) of in one’s teens adults who had a time without insurance coverage in the past year had gone without needed health care because of cost. One-half reported problems paying medical bills or were paying off medical debt over delivery.
Nearly 60 percent of employers who offer coverage do not insure dependent children over age 18 or 19 if they do not attend college. Thirty-nine percent of in one’s teens adults ages 19 to 23 who either do not attend college or only attend part-time are uninsured, compared with 17 percent of full-time students.
In the face of these challenges, new efforts on both the state and federal level to cover young adults are gaining essential element. Twenty states have passed legislation requiring insurance companies to extend dependent coverage to young adults older than 18 or 19. The new age limits course from 24 in Delaware, Indiana, and South Dakota to 30 in New Jersey. In addition, a recently introduced congressional bill would extend health insurance to dependent children of federal workers to age 25.
Because a majority of young adults without medical insurance have low incomes, extending eligibility for Medicaid and SCHIP beyond age 18 would also be an important policy solution for covering this group, the authors say. Such an expansion would have the biggest impact in terms of lowering the number of uninsured young adults. Extending eligibility to age 25, for example, would cover up to 7.6 million young adults without health insurance that live in households with incomes below 200 percent of poverty.
“State-level efforts to cover young adults are very important and will help many young adults as they transition to the labor force,” said Commonwealth Fund President Karen Davis. “However, most uninsured young adults do not have access to affordable private coverage through their parents’ plans. Extending Medicaid and SCHIP coverage beyond age 18 has the potential to make a real difference in the lives of young adults and their families.”
In addition, the authors suggest that states could help extend health insurance coverage by ensuring that colleges and universities require health coverage and offer insurance to their full-time and part-time students. This option could refrain from cover the 1.6 very great number part-time and full-time uninsured students ages 19 to 23.
Orval Kent Foods Recalls Amish Macaroni Salad
Author: admin
Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk.
This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7.
It is of influence to note that no illnesses associated with consumption of this product have been reported.
The only product included in this recall is Amish Macaroni Salad with the following UPC codes and associated Use By dates:
* UPC 7945368281 Orval Kent Amish Macaroni Salad, 5 pound container, Use By 6/12/08
* UPC 7347468281 Yoder’s Amish Macaroni Salad, 1 pound container, Use By 6/7/08
* UPC 7347401045 Yoder’s Amish Macaroni Salad, 2 pound container, Use by 6/7/08
* UPC 7347488729 Yoder’s Amish Macaroni Salad, 5 pound container, Use By 6/7/08
This specific product was shipped to customers who have distribution to retail and food service establishments in the following areas: Delaware, Illinois, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, and Pennsylvania.
E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely with a week, some people can grow a form of kidney failure that be possible to lead to serious kidney damage and even death. Young children, the somewhat old and those with weak immune systems are most susceptible to foodborne illnesses.
No other Yoder’s or Orval Kent deli salads, or other code dates or UPC’s of the Amish Macaroni Salad are included in this recall.
Our highest priority is protecting the health and safety of our customers, consumers and their families. Today’s precautionary action is a determined length to ensure this priority is carried out, and that we maintain the loyalty and faith of our consumers.
Consumers are urged to return all un-opened containers to their place of purchase for a full refund.
ImClone To Feature ERBITUX At ASCO
Author: admin
ImClone will feature ERBITUX in two presentations during the June 1 Plenary Session at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting.
More than 30,000 cancer specialists from around the world will gather at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago to canvass the latest advances in cancer care, treatment, prevention and survivorship. The meeting will be held at McCormick Place, Friday, May 30 through Tuesday, June 3, 2008. Nearly 4,300 abstracts have been accepted to the five-day meeting.
This year ASCO is changing its Annual Meeting abstract distribution process:
Non-Plenary and Non-Late-breaking abstracts (to have existence published in the 2008 ASCO Annual Meeting Proceedings Part I) will be publicly released online at www.asco.org on Thursday, May 15 at 9:00 PM (EDT). Study authors will not heedless select noteworthy research in a live, online presscast for pre-registered media earlier that day.
Plenary and Late-breaking abstracts (to be published in the 2008 ASCO Annual Meeting Proceedings Part II) will be publicly released at various times for the time of the Annual Meeting and highlighted in press briefings on Saturday and Sunday.
A new reflection finds that recent guidelines outlined by the American Heart Association (AHA) for treatments used by emergency and critical care medicinal practitioners on heart attack patients has lead to substantial improvements in survival rates. The findings show that, when fully implemented, the treatment protocol increased the odds of survival nearly four-fold for victims of cardiac arrest.
The study, led by Drs. Paul Hinchey, Brent Myers of the Wake County EMS System in Raleigh, N.C, is the first comprehensive evaluation of 2005 American Heart Association guidelines on the use of compression, ventilation and induced hypothermia after community-wide implementation. The results are based on the outcomes of adults treated for cardiac arrest by emergency responders in an urban/suburban emergency medical services system with existing advanced life support.
The authors highlight the benefits of a healthcare community being able to implement a comprehensive care plan for victims of cardiac arrest “from the living room of the victim’s home to the intensive care unit (ICU).”
The essential elements of this plan were a focus on simple, continuous cordial compressions, controlled ventilations, early utilization of induced hypothermia and convict of resuscitated patients to specialized post-resuscitation hospitals.
There is ample evidence to support the conversion to an act of continuous compressions and induced hypothermia. However, heterogeneous previous studies that demonstrate the effectiveness of full of character interventions on a study population, this study demonstrates the substantial impact that comprehensive implementation of a multi-disciplinary treatment protocol can esteem on a community.
“Our findings not only demonstrate beneficial outcomes by reason of victims of cardiac engage, but also suggest the possibility that such treatment plans can be implemented for other medical conditions,” say the authors.
The presentation is entitled “Out-of-Hospital Cardiac Arrest Survival after the Sequential Implementation of 2005 AHA Guidelines for Compressions, Ventilations, and Induced Hypothermia.” This paper will have being presented at the 2008 SAEM Annual Meeting, May 29-June 1, 2008,Washington, D.C. on Friday, May 30, 2008, in the oral dissertation presentations from 2:00 – 3:30 pm in the Virginia A & B rooms of the Marriott Wardman Park hotel. Abstracts of the papers presented are published in Vol. 15, No. 5, Supplement 1, May 2008 of the official magazine of the SAEM, Academic Emergency Medicine.
FDA today issued a public health advisory to wary patients, caregivers and health care professionals to lash 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 on this account that CFC-propelled albuterol inhalers."
Albuterol inhalers are used to deal by 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 one 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.