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Adverse drug reactions companies

Since the individual drug trials are too small, too short, and otherwise inadequate to the task, it remains the ultimate responsibility of the drug company to go through the complete, combined database in search of patterns of adverse drug reactions. Even if drug companies were properly motivated, there is no foolproof way to oversee the entire group of several thousand patients. [Pg.359]

In 1986, nearly two decades after NMS had become an identifiable syndrome, the FDA at last began to force the drug companies to add the adverse drug reaction to their neuroleptic labels. Since the disease is fatal in approximately 20% of cases when it goes unrecognized and untreated, the failure to properly inform physicians cost many lives and untold suffering. [Pg.366]

The largest manufacturer of Eplwdra-contammg supplements is Metabolife. The firm has repeatedly insisted that it was not aware of adverse events associated with its products, and claimed that they were absolutely safe (13). An investigation by the US Justice Department into the truth of these statements showed that between 1997 and 2002 the company had received over 13 000 reports of suspected adverse drug reactions they included nearly 2000 reports of significant adverse reactions. [Pg.1223]

A yellow card system exists which can be used by physicians, dentists cind pharmacists to report the adverse drug reactions (ADRs) that their patients are experiencing. Companies can also voluntarily communicate ADRs. Post-marketing surveillance in Belgium is regulated by the following laws ... [Pg.61]

When a company is intending to carry out a post-marketing surveillance study it must advise the Adverse Drug Reactions Advisory Committee (ADRAC) of its intention. [Pg.196]

Pharmaceutical companies must report suspected adverse drug reactions noted during postmarketing surveillance studies. [Pg.196]

From the point of view of a pharmaceutical company, the worst way in which things can go wrong is when the marketing authorization for a major product is threatened with revocation or suspension due to reports of serious or fatal adverse drug reactions. [Pg.579]


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Adverse drug reactions

Drug companies

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