We have been hearing regularly from Food and Drug Administration (FDA) for last few weeks in relation to the warning letter that has issued to FMCG. I am wondering if the current Obama government has tightened up the regulations or the companies are doing badly. Last month FDA issued warning letter against General Mills for labeling on Cheerios. About two weeks back FDA warned that Zicam cold remedy can cause a temporary or permanent loss of smell and then found that Nestle cookie dough is associated with food poisoning.
Recently, FDA gave warning to Pfizer and GlaxoSmithKline to add a black boxed warning on their anti-smoking drugs Chantix and Zyban (also known by their pharmaceutical names varenicline and bupropion) to highlight the risk of serious mental health problems, including changes in behavior, depressed mood, hostility and suicidal thoughts or behavior.
It’s really an alarming situation. As smoking in itself leads to various health risks and if antismoking drugs will also pose health concerns, smokers would be discouraged to quit smoking with the use of drugs.
As per Center for Disease Control (CDC) each year, an estimated 443,000 people die prematurely from smoking or exposure to secondhand smoke, and another 8.6 million have a serious illness caused by smoking.
We all know that smoking is injurious to health. Millions of non smoking people are regularly exposed to secondhand smoke that can cause serious health issues and even death. Health issues include heart disease and lung cancer in nonsmoking adults and sudden infant death syndrome, acute respiratory infections, ear problems, and more frequent and severe asthma attacks in children.
As per a CDC report, each year, primarily because of exposure to secondhand smoke, an estimated 3,000 nonsmoking Americans die of lung cancer, more than 46,000 die of heart disease, and about 150,000–300,000 children younger than 18 months have lower respiratory tract infections.
How do anti-smoking drugs work?
When you smoke, the nicotine from your cigarette stimulates receptors in your brain to release various chemicals, including dopamine. Dopamine may give pleasurable feeling when you smoke. The anti-smoking drugs acts on nicotine receptors in the brain and block the release of the chemicals. Low levels of dopamine and other chemicals in the brain stops the positive and pleasurable feelings and then decrease your craving for nicotine or smoking.
As discussed anti smoking drugs block the release of various chemicals from brain. Lower levels of these chemicals sometimes cause miserable signs and symptoms of nicotine withdrawal such as irritation, insomnia and difficulty in concentration for more than four to six hours after your last cigarette. These symptoms can last a month or more after you quit smoking.
Besides nicotine replacement products, including the patch, gum and lozenges, Zyban (bupropion) and chantix (varenicline) are the...
major anti smoking drugs.
Chantix was introduced in 2006 and has about 90 percent of the market for prescription smoking-cessation drugs, according to IMS Health, a health care information company. Even so, Chantix sales were $846 million in 2008, which were lower than Pfizer had expected. One of the reasons is the previous warnings of its side effects.
Why FDA warned against both the drugs?
The FDA announced that patients taking two popular drugs to stop smoking, Zyban and Chantix reported signs and symptoms of serious mental illness and suicides. Reports say that taking the drugs may cause changes in behavior and mood, including hostility, agitation, depression and suicidal thoughts or behavior. The new warnings will be included in a “black box” intended to alert consumers to important side effects of a drug.
How many suicidal attempts and behavior have been observed so far?
The most disturbing reports by the FDA involving suicide are as follows:
- 98 completed suicides in Chantix users
- 14 completed suicides in Zyban users
- 188 attempted suicides in Chantix users
- 17 attempted suicides in Zyban users
Robert J. Temple, MD, director of the FDA’s office of medical policy, said at a news conference “We want people to use these drugs carefully and pay attention”. Stopping smoking is a goal we all want to work toward. We don’t want to scare people off these drugs — we just want them carefully monitored.
What is the safety measure taken by FDA?
The FDA requires Pfizer and GlaxoSmithKline to mention the risk of suicide in advertising and to conduct clinical trials to evaluate whether the drugs actually cause suicidal tendencies and behavior changes. Unlike the clinical trials upon which drug approval was based, the new studies will enroll smokers with underlying psychiatric disorders.
As FDA has recommended companies to do a controlled study to look into behavioral changes after consumption of Chantix and Zyban, which indicates that the drugs may not be fully responsible for suicides and behavioral change. As a matter of fact smokers are addicted to nicotine and when they quit, their withdrawal symptoms can include many bizarre behaviors, including suicide. However, Curt Rosebraugh, MD, MPH, director of one of the FDA’s drug evaluation units, said that some of the suicide reports came from Chantix users who were still smoking.
I think on a safer note, addition of warning labels on the product package and marketing campaigns seems an appropriate step. Unless the data from forthcoming planned clinical trials shows Chantix and Zyban to be safer for the patients, you should take caution and consult your doctor, if you decide to be on these therapies.