Paxil

paroxetine

Common misspellings of this drug’s name:

• Paxel
• Packsil
• Pacsel
• Pacsil
• Pacil

Paxil is one of a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Paxil was first approved in the United States on December 29, 1992, for the treatment of depression.

SSRI’s work by slowing the removal of specific chemicals that are needed for normal brain function from the brain. SSRI’s make these chemicals more available to the brain.

The FDA has been investigating the potential harmful side effects the drug Paxil causes its users since June of 2003. There are reports that the drug has caused an increased risk of violent behavior, suicidal thinking, and suicide attempts, especially in adolescents.

Common side effects observed in patients taking Paxil include:

• headache
• dizziness
• weakness
• difficulty concentrating
• nervousness
• forgetfulness
• confusion
• sleepiness or feeling “drugged”
• difficulty falling asleep or staying asleep
• upset stomach
• vomiting
• diarrhea
• constipation
• gas
• stomach pain
• heartburn
• changes in ability to taste food
• decreased appetite
• weight loss or gain
• changes in sex drive or ability
• dry mouth
• sweating
• yawning
• sensitivity to light
• runny nose
• cough
• lump or tightness in throat
• pain in the back, muscles, joints, or anywhere in the body
• muscle weakness or tightness
• flushing
• problems with teeth
• unusual dreams
• painful or irregular menstruation

Although rare, patients should immediately contact their doctors if they experience any of the following serious side effects:

• blurred vision
• rapid, pounding, or irregular heartbeat
• chest pain
• seizure
• abnormal bleeding or bruising
• sore throat, fever, chills, and other signs of infection
• shaking hands that you cannot control
• sudden muscle twitching or jerking that you cannot control
• numbness or tingling in your hands, feet, arms, or legs
• difficult, frequent, or painful urination
• swelling, itching, burning, or infection in the vagina
• painful erection that lasts for hours
• sudden upset stomach, vomiting, weakness, cramping, bloating, swelling, tightness in hands and feet, dizziness, headache and/or confusion
• hives
• skin rash
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• black and tarry stools
• red blood in stools
• bloody vomit
• vomiting material that looks like coffee grounds

The FDA currently recommends that Paxil not be used in children and adolescents in the treatment of Major Depressive Disorder, or MDD.

More disturbing are recent indications that GlaxoSmithKline, the makers of Paxil, may have withheld from the public results of its own studies that showed Paxil had little or no effect in treating depression in adolescents.

ABC News also revealed on its “Primetime Live” broadcast on December 9, 2004, that as early as 1997, GSK was aware of studies linking suicidal behavior in patients to the drug.

In July 2006, the Food and Drug Administration (FDA) updated information about SSRI’s to include facts about a life-threatening condition called serotonin syndrome. This condition occurs when SSRI’s are taken at the same time as medicines used to treat migraine headaches, called triptans.

Also in July 2006, the FDA release information about a study on the effect SSRI’s may have on pregnancy. The study found that babies born to women who took SSRI’s at least 20 weeks into their pregnancies were 6 times as likely to have persistent pulmonary hypertension (PPHN) than babies born to mothers who did not take SSRI’s during pregnancy.

Babies who are born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. PPHN makes babies very sick and is possibly fatal.

Source: “Paroxetine,” MedlinePlus Drug Information Sheet, January 1, 2007; “Drug Maker Withheld Paxil Study Data,” ABCnews.com, December 9, 2004; “Citalopram Hydrobromide (marketed as Celexa),” Food and Drug Administration Drug Information Sheet, July 2006.