AstraZeneca has been warned by the FDA that promotional material for its antipsychotic drug Seroquel is misleading and should no longer being distributed.
Seroquel is indicated for the treatment of acute manic episodes associated with bipolar disorder and for the treatment of schizophrenia.
According to the warning letter posted on the FDA Web site Wednesday, the sales material "minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia and the bolded cataracts precaution."
The drug's label says neuroleptic malignant syndrome, which can be fatal, has been reported in association with administration of antipsychotic drugs, including Seroquel.
The syndrome manifests as hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability, including irregular pulse or blood pressure, tachycardia and cardiac dysrhythmia.
The label also states that tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.
The FDA requested that AstraZeneca stop disseminating the material, adding that the company has until Nov. 30 to respond to the warning.
More at smartmoney.com
1 comment:
This big drug Co. as others uses this method of promotion that is based on the principal. that is easier to appologise than to ask for permision. They know that misleading and false claims are not allowed, but they push the envelope every time they feel like it. Even if they are fined, the amounts are so small that they simply pay up and laught it off. However, the benefits of missleading/false claims maybe far larger in terms of additional sales, that all big pharma do it routinely and deliberately.
Here is an exerpt from an actual memo of recall of offending literature that makes false claims in promo of an antihypertensive drug (not by Astra) to be replaced by another for the current sales cycle:
"At this upcoming cycle meeting, you will receive an update of this tool. Since the new and old tool are not PAAB approved, in order to recive the update you will need to bring back the old version to the cycle 3 meeting.....The old copies must be given back to marketing for destruction. With this procedure we hope to limit the circulation of non PAAB toops. This is a serious matter for XXXXXX at this time. There is an increasing number of complaints and we don't want to jeopardise our future indication for XXX."
One can see that such marketing practices are very common and noboby seems to be able to stop it. They get a slap on their wrist and practice continues. The benefits are too large and the concequences too small for them to give it up.
Ps. PAAB, regulates the promotional practices to adhere to the Health Care act in Canada.
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