Merck not only caught up by skipping a stage of trials (a risky move that often backfires), but its Januvia pill emerged with the entire market for the class when the Novartis drug ran into side effect problems at the FDA and was never approved.
The case illustrates the difficulty of pinning a side effect to a particular drug based on the scant reports of side effects that come to the FDA. It is extremely difficult to link a side effect, like an inflamed pancreas, with a particular drug.
At best, it signals broad trends or prompts action if there is a proven or at least a strong correlation between the drug and a suspected side effect.
Merck researchers in Canada realized that a failed asthma drug could reduce this flushing side effect in 2003.
Merck is working on a drug that counteracts a major side effect of Niacin, an HDL-raiser that is already on the market.
Tredaptive included niacin, a statin and another drug meant to reduce the flushing side effect of niacin.
Soon-Shiong, a surgeon who made his initial riches selling generic drugs to hospitals, has always insisted that the drug was more than just side-effect-sparing.
If new symptoms turn up after taking a new medicine, they could be a side effect of the drug, not a symptom of the disease.
Researcher Dr John Kastelein, from the Academic Medical Center in Amsterdam, The Netherlands, said the only side effect of the drug was some mild stomach problems.
The withdrawal "is consistent with our expectations that if there was a cardiovascular problem, the more potent the drug, the more likely the side effect, " says Leonard Yaffe, an analyst at Banc of America Securities.
Before the meeting, some worried that the lung cancer data for the drug would be marred by a side effect: In earlier trials, 9% of patients had bled to death from their lungs while on Avastin treatment.
Those will take years, and a single serious side effect could sink the drug.
Cordaptive combines niacin, an already approved heart medicine, with a new drug that alleviates niacin's main side effect, hot-flash-like flushing.
The niacin pill will be paired with another drug to curtail niacin's main side effect of unpleasing flushing or an overheated feeling.
The logic is that patients are likely to be switched to a new drug if they have either a bad side effect, such as diabetes or involuntary movements, or a worsening of schizophrenia symptoms.
When a drug is likely to cause a severe side effect--say, an increased risk of heart attack, an allergic reaction that causes the skin to burn or liver failure--the standard practice is to warn patients and doctors about the product's labeling, and to send out warning letters to physicians who might prescribe the medicine.
But it was going to be combined with a new drug that would ease niacin's main side effect: profound flushing, almost a hot flash, that is so unpleasant that patients choose not to use the drug.
On a conference call, Arena Chief Executive Jack Lief said that there were heart valve problems seen in the trial, but that in the end he expects no difference between Arena's drug and placebo when it comes to this side effect.
To date, no drug has been approved in its leaf form because plants contain a complex composition of compounds with uncertain pharmacologies, metabolisms, side-effect profiles, toxicologies, drug interactions, and no control of relative concentrations.
But a serious new side effect was discovered that might torpedo the drug.
Not only does the technique tell you that your drug has had the desired effect it can also flag side effects you hadnt suspected.
If the FDA reviewed the data and negotiated the text of the drug label, how can Levine sue for failure to warn about a side effect?
Doubts grew that Avastin wouldn't work, or that some serious side effect such as gastrointestinal bleeding would ground the once-promising drug.
It could even be that niacin is effective, at least in some people, or that the unknown side effect occurred in a predictable way that would not mean the drug should never be given.
FORBES: Why Merck's Niacin Failure Will Scare Drug Researchers
The drug's label will be updated to warn doctors and patients about this possible side effect.
Long-term, daily use of inhaled corticosteroids may slightly slow their annual growth rate, a side effect that's thought to be reversible when children stop taking the drug.
In this era of drug-spending cutbacks and safety panics it would seem like a recipe for failure: a drug that helps only a fifth of patients and might even have a rare, dangerous side effect.
Peter Appelbaum, an expert in resistant bacteria at Penn State, says the drug has been in development for 15 years and causes more nausea than other drugs--a side effect that could crimp Wyeth's rosy forecasts.
Porges points out that because of the side effect issues, doctors may choose to try Copaxone instead of Avonex as half of a drug combo.
Arena Pharmaceuticals' experimental obesity drug passed a crucial safety test, but it may take at least six more months before worries about a potential side effect really start to abate.
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