FDA Approved For:
May 11, 1999 -- The United States Food and Drug Administration has approved SmithKline Beecham’s Paxil(R) (paroxetine HCl) for the treatment of social anxiety disorder, making it the first and only medication approved for this disorder in the U.S.
September 2, 2003 - GlaxoSmithKline today announced the US Food and Drug Administration (FDA) approved Paxil CR (paroxetine HCl) Controlled-Release Tablets as the first controlled-release medication for the treatment of premenstrual dysphoric disorder, a condition affecting three to eight percent of women of reproductive age in the United States. Premenstrual dysphoric disorder (PMDD) is characterised by intense emotional symptoms including irritability, tension, and depressed mood as well as physical symptoms associated with the menstrual cycle. Paxil CR is also indicated for the treatment of depression and panic disorder.
FDA Alerts
Persistent Pulmonary Hypertension (7/2006)
The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) were recently published in a medical journal.Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die.
The study results showed that:
- babies born to mothers who took selective serotonin reuptake inhibitors (SSRIs), the family of medicines Prozac belongs to,
- 20 weeks or later in their pregnancies,
- had a higher chance (were 6 times as likely) to have persistent pulmonary hypertension (PPHN),
- than babies born to mothers who did not take antidepressants during pregnancy.
SSRIs/SNRI/Triptan and Serotonin Syndrome (7/2006)
A life-threatening condition called serotonin syndrome (serious changes in how your brain, muscles and digestive system work due to high levels of serotonin in the body) can happen when medicines called selective serotonin reuptake inhibitors (SSRIs), such as Prozac, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are used together. Signs and symptoms of serotonin syndrome include the following:
restlessness
diarrhea
hallucinations
coma
loss of coordination
nauseafast heart beat
vomiting
increased body temperature
fast changes in blood pressure
overactive reflexesSerotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. This information comes from reports sent to FDA and knowledge of how these medicines work. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.
Before you take Prozac and a triptan together, talk to your healthcare professional. If you must take these medicines together, be aware of the possibility of serotonin syndrome, and get medical care right away if you think serotonin syndrome is happening to you.
