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 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.
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.
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.
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.
The niacin pill will be paired with another drug to curtail niacin's main side effect of unpleasing flushing or an overheated feeling.
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.
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?
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.
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.
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