FDA issues two health advisories over antidepressants, migraine drugs

[Guest guest]

July 19, 2006

FDA issues two health advisories over antidepressants, migraine drugs

by Marie-Eve Laforte

The FDA issued a public health advisory warning patients and doctors about

the risks of serotonin syndrome that may occur when triptan drugs, used to

treat migraines, are taken in combination with some types of

antidepressants. Separately, the agency issued a different advisory

requesting that drugmakers that market selective serotonin reuptake

inhibitors update the labelling for their drugs to reflect the risk of

persistent pulmonary hypertension (PPHN) in infants born to women who take

the antidepressants during pregnancy.

Regarding the combination of triptan drugs and antidepressants, the FDA

indicated that the life-threatening condition serotonin syndrome may occur

when patients take drugs in the triptan class, in conjunction with either

SSRIs or selective serotonin/norepinephrine reuptake inhibitors (SNRIs). The

agency noted that it has examined 27 reports of the syndrome, including two

cases that were considered life-threatening, as reported in SmartMoney. The

syndrome, which includes symptoms such as hallucinations or abrupt changes

in blood pressure, " may be more likely to occur when starting or increasing

the dose of a triptan, SSRI or SNRI, " the US regulatory agency said.

Additionally, the FDA requested that all drugmakers of triptans, SSRIs and

SNRIs update the labelling information for their products to reflect the

risk of developing the condition when triptans and SSRIs or SNRIs are used

together.

In a separate advisory, the agency suggested that patients and doctors must

" carefully consider " the benefits and risks of taking antidepressants during

pregnancy. In its advisory, the FDA cited two recent studies investigating

the use of antidepressants in pregnancy. Results from one study suggested

that PPHN was six times more common in babies whose mothers were treated

with an SSRI antidepressant in the second half of pregnancy, compared to

women who did not take an antidepressant.

Although this " uncommon potential risk " of PPHN in babies has not been

confirmed by additional studies, the agency asked SSRI manufacturers to

update their labels to reflect this potential risk. Meanwhile, the FDA said

it is " seeking additional information " about the possible risk of PPHN in

newborns.

Regards,

You don't drown by falling in the water.

You drown by staying there.