But now Schering says it is adding two new allergic side effects to the drugs label.

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One problem: There may be warnings about cardiac and other side effects on the drug's label, although Iannini thinks these worries have been largely dispelled.

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In January, Pfizer and the FDA added concerns about those side effects to the drug's label, which serves as a guide for doctors and the basis for claims in advertising.

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To improve the reporting of side effects to the FDA, the label will now include a toll-free number and an Internet address to encourage doctors and patients to report potential problems.

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The drug's label will be updated to warn doctors and patients about this possible side effect.

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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?

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The new label adds a clearer warning regarding the risk of rare muscle-weakening side effects that can lead to kidney damage or death.

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Despite the adage that you should never bargain against yourself, be willing to make a concession so long as you label it as difficult to make and expressly note that you expect reciprocity from the other side.

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The Beatles changed the name of their company that oversaw their business interests to Apple in 1967, and released most of their later albums on the Apple Records label, with its distinctive labeling--a green-skinned Apple on the A-side and the halved apple for the B-side.

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The new label warned that giving Baycol with Lopid, a Pfizer cholesterol drug, substantially increased the likelihood of potentially dangerous muscle side effects.

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