FDA warns of Zyban, Champix depressive side-effects
Last Updated: Thursday, July 2, 2009 | 12:41 PM ET Comments97Recommend38The Associated Press
The U.S. Food and Drug Administration will require two smoking-cessation drugs, Champix and Zyban, to carry the agency's strongest safety warning over side-effects including depression and suicidal thoughts.
The new requirement, announced Wednesday, "will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs," the FDA said in a statement on its website.
Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug.
“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research.
The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC's Zyban, already carries such a warning.
The FDA said it is also requiring an additional study on Champix and Zyban to determine the extent of the side-effects. Pfizer Inc., which makes Champix, said it is still discussing the potential study design with the FDA.
Sunday, July 5, 2009
Stiffer warnings for Champix/Chantix, Zyban from Australia
Stiffer warnings for Champix /chantix, Zyban
Drug regulators are set to bolster the warning requirements of two popular smoking cessation drugs in response to continuing concerns over their serious psychiatric side effects.
The Therapeutic Goods Administration (TGA) said it would "strengthen" prescribing and consumer information warnings for Champix (varenicline) and Zyban (bupropion), following a decision earlier in the week by its US counterpart. known as Chantix in the US market.
Drug regulators are set to bolster the warning requirements of two popular smoking cessation drugs in response to continuing concerns over their serious psychiatric side effects.
The Therapeutic Goods Administration (TGA) said it would "strengthen" prescribing and consumer information warnings for Champix (varenicline) and Zyban (bupropion), following a decision earlier in the week by its US counterpart. known as Chantix in the US market.
still smoking now coughing
Coughing.
Coughing up phlegm, infectious germs, and foreign substances is one of the ways in which the lungs protect themselves. Severe coughing, however, may signal lung disease. Obstructive diseases of the lungs (asthma and COPD) and lung cancer often cause a person to cough up phlegm, which, if yellow or green, may signal an infection. Coughing up blood is a critical sign, especially in a current or former cigarette smoker. It may suggest a potentially life-threatening disease, such as lung cancer or pulmonary embolism, although it can also be a sign of a less serious lung problem such as bronchitis.
Coughing up phlegm, infectious germs, and foreign substances is one of the ways in which the lungs protect themselves. Severe coughing, however, may signal lung disease. Obstructive diseases of the lungs (asthma and COPD) and lung cancer often cause a person to cough up phlegm, which, if yellow or green, may signal an infection. Coughing up blood is a critical sign, especially in a current or former cigarette smoker. It may suggest a potentially life-threatening disease, such as lung cancer or pulmonary embolism, although it can also be a sign of a less serious lung problem such as bronchitis.
Short of breath? Coughing? Chest pain?
All That Wheezes Is Not Asthma
Short of breath? Coughing? Chest pain? Johns Hopkins doctors explain why you should take your symptoms seriously.
Many lung disorders produce similar symptoms, but the severity and duration of these symptoms can vary considerably from disease to disease. The lung disorders can be acute (short and relatively severe) or chronic (persisting over a long time).
Chronic lung conditions may wax and wane in severity and can worsen quickly and markedly if another problem, such as a lung infection, occurs. Some people, however, have only mild symptoms or none at all. In these individuals, the lung disorder may be detected on a chest x-ray or by a test to check lung function.
Shortness of breath. Shortness of breath can dramatically compromise quality of life. The underlying cause of shortness of breath is usually a mechanical problem in the lungs or diaphragm (the large, dome-shaped muscle located at the base of the lungs). Examples of mechanical problems are airway obstruction (as occurs in asthma, COPD, and some lung cancers); increased stiffness of the lungs (as in interstitial lung disease, pneumonia, and heart failure); severe spine and rib cage abnormalities; and obesity.
If left untreated, shortness of breath can lead to fatigue and weakness that may profoundly limit activities. In turn, weakness related to being out of shape or musculoskeletal disease, such as severe curvature of the spine, may aggravate shortness of breath.
Short of breath? Coughing? Chest pain? Johns Hopkins doctors explain why you should take your symptoms seriously.
Many lung disorders produce similar symptoms, but the severity and duration of these symptoms can vary considerably from disease to disease. The lung disorders can be acute (short and relatively severe) or chronic (persisting over a long time).
Chronic lung conditions may wax and wane in severity and can worsen quickly and markedly if another problem, such as a lung infection, occurs. Some people, however, have only mild symptoms or none at all. In these individuals, the lung disorder may be detected on a chest x-ray or by a test to check lung function.
Shortness of breath. Shortness of breath can dramatically compromise quality of life. The underlying cause of shortness of breath is usually a mechanical problem in the lungs or diaphragm (the large, dome-shaped muscle located at the base of the lungs). Examples of mechanical problems are airway obstruction (as occurs in asthma, COPD, and some lung cancers); increased stiffness of the lungs (as in interstitial lung disease, pneumonia, and heart failure); severe spine and rib cage abnormalities; and obesity.
If left untreated, shortness of breath can lead to fatigue and weakness that may profoundly limit activities. In turn, weakness related to being out of shape or musculoskeletal disease, such as severe curvature of the spine, may aggravate shortness of breath.
Subscribe to:
Posts (Atom)
