Access To Justice

According to published reports, U.S. drug reviewers are calling on federal regulators to further study the effects of atypical antipsychotic medicines in children.  In a report published earlier this month, the staff of the FDA said a study of the medical literature found a direct link between treatment with atypical antipsychotics and adverse metabolic effects including abnormal weight gain and increases in cholesterol and blood pressure, particularly among younger age groups.

Specifically, the FDA analysis showed increased reporting of metabolic problems with Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel.

The concerns about Zyprexa and Seroquel are just the latest in a long history of potentially dangerous side effects associated with prescription medications.

To me, these reports are extremely concerning.  Back in January, a study in the New England Journal of Medicine suggested that newer, second-generation antipsychotics such as Seroquel might pose heart risks — specifically, a higher risk of sudden death due to cardiac arrest.  Then in April, the FDA found that Seroquel had too many safety concerns to make it a first-line treatment against depression or anxiety disorders.

That’s a lot of concern being raised about one drug in a single year.  Overall it seems that Seroquel — like many drugs — can be quite effective for certain patients. However, for many other patients there are wide reports of dangerous side effects.  More troubling is the fact that these drugs are often prescribed for children.

When you look at the three adverse studies that have come out this year, one wonders whether the FDA has done all the diligence it should to ensure that the drug is safe.  Do we know all we should about the side effects? Or should we expect a new round of research to tell us of even more risks?  Against this backdrop; perhaps the safety of the drug is not the only thing in question, perhaps the credibility and effectiveness of the FDA are as well.

There’s more on the newer class of antipsychotic medications at the U.S. Food and Drug Administration.