Why Was Zyban Discontinued and Withdrawn From The Market?
Zyban is a brand name for the drug bupropion, which is primarily used as an antidepressant medication but can also be prescribed as a smoking cessation aid. The drug works by increasing the levels of certain chemicals in the brain that are associated with mood and addiction.
When used for smoking cessation, Zyban is typically prescribed for a course of several weeks, during which time the individual gradually reduces their smoking until they are able to quit completely. It is important to note that Zyban may not be effective for everyone, and it can have side effects such as insomnia, dry mouth, and nausea.
The history of Zyban is closely tied to the history of the drug bupropion. Bupropion was first developed in the late 1960s as an antidepressant medication by the pharmaceutical company Burroughs Wellcome (now part of GlaxoSmithKline). It was approved by the United States Food and Drug Administration (FDA) for use as an antidepressant in 1985.
In the 1990s, researchers began to investigate bupropion’s potential as a smoking cessation aid. It was found that the drug could help reduce nicotine cravings and withdrawal symptoms, and in 1997, the FDA approved bupropion under the brand name Zyban as a smoking cessation aid.
Since its approval, Zyban has been used by millions of people around the world to help them quit smoking. It’s worth noting that the use of bupropion as a smoking cessation aid is not without controversy. Some studies have suggested that the drug may increase the risk of seizures, particularly in people with a history of seizures or other risk factors. Additionally, like all medications, bupropion can have side effects and may not be appropriate for everyone.
Why Was Zyban Discontued?
Zyban was discontinued and withdrawn from the market for safety reasons. In December 2022, internal testing of the drug by GSK revealed traces of nitrosamine impurities. Nitrosamine impurities are a type of potentially carcinogenic (cancer-causing) compound that can be found in certain medications and other products. Nitrosamines are formed when certain chemicals react with nitrites under certain conditions, such as during the manufacturing process of some pharmaceuticals.
The discovery of nitrosamine impurities in medications has been a cause for concern in the pharmaceutical industry and regulatory agencies around the world. In recent years, several medications have been found to contain unacceptable levels of nitrosamines, leading to recalls and warnings from regulatory agencies.
As a result, of the nitrosamine impurities found in Zyban, GSK placed an immediate hold on the batch release and distribution of Zyban 100 mg and the 150 mg prolonged-release tablets.
The good news is that the patent for the brand name Zyban has expired and generic versions of the drug, which is simply called bupropion, is widely available and commonly prescribed as both an antidepressant and a smoking cessation aid.
There are also other medications that can be used for similar purposes.
For depression:
• Selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil)
• Serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine (Effexor) or duloxetine (Cymbalta)
• Tricyclic antidepressants (TCAs) such as amitriptyline (Elavil) or nortriptyline (Pamelor)
For smoking cessation:
• Nicotine replacement therapies (NRTs) such as nicotine gum, patches, or lozenges
• Varenicline (Chantix), a medication specifically designed to help people quit smoking
It’s important to note that medication should only be taken under the guidance of a healthcare professional, and that the specific medication prescribed will depend on the individual’s unique situation and needs.
It’s possible that there may be some local or temporary shortages of Zyban due to factors such as supply chain issues or manufacturing problems, but this would not necessarily indicate that the drug has been discontinued.
It’s worth noting that even if a brand name drug is discontinued, this does not necessarily mean that the drug itself is no longer available. In many cases, generic versions of the drug are still available and can be prescribed by healthcare professionals.
Is Zyban banned in Europe?
No, in December 2003, the UK banned the use of 4 antidepressants for children; it had banned 2 others earlier last year. The US Food and Drug Administration followed on March 22 with a strongly worded warning about the drugs.
A recent European review of safety data for Zyban identified at least 8 cases of serotonin syndrome, a potentially life-threatening condition, where a possible interaction between bupropion and a serotonergic drug was thought to have led to serotonin syndrome. The review also identified 6 cases with good evidence of an association with an overdose of bupropion. In the majority of these cases the patients had intentionally taken more than the prescribed dose.
