A few official Paxil warnings have been issued over the years including the risk of increased suicidality (suicidal thoughts and behaviors) in teens and young adults, the increased risk for birth defects when taking Paxil during pregnancy, and more.
What Is Paxil?
Paxil (paroxetine, Seroxat) is a prescription medication used to treat depression, anxiety, panic attacks, post traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), among others.
Manufactured by GlaxoSmithKline, it belongs in the class of drugs called SSRI's (selective serotonin reuptake inhibitor).
In June 2003, the British drug regulatory agency ruled that Paxil should not be prescribed for children with depression due to increased risk of suicidality and aggression.
The Medicine and Healthcare Products Regulatory Agency (MHPRA) reviewed the data and results from 9 clinical trials and released the following statement: "It has become clear that the benefits of Seroxat (Paxil) in children for the treatment of depressive illnesses do not outweigh the risks."
A few months later in October 2003, the FDA released an official warning regarding a possible increase in suicidality and aggression in children and teenagers using Paxil. As a result, it is not approved for use in children under 18 and is not prescribed for patients under the age of 24 without careful consideration.
In March 2006, an FDA research team reviewed studies on children and suicide and concluded that SSRI use increases risks for suicidal thoughts and behavior in patients under 18.
It is important to note that while the British government has officially disapproved use in children and young adults the United States' FDA issues on warnings.
Studies have linked Paxil to heart defects, and malformations of the head and abdomen. In December 2005, the FDA issued a Paxil warning regarding the risks of birth defects in babies born to pregnant women taking Paxil, citing “the risk of congenital malformations, particularly cardiovascular malformations.”
In March 2006, Health Canada issued an official warning for pregnant women to take precautions if taking SSRI's during pregnancy due to the health risks to developing fetuses. Also in 2006, a study linked SSRIs with a sometimes fatal lung condition called PPHN (persistent pulmonary hypertension of the newborn) in infants whose mothers had taken the drugs.
In addition, Paxil can pass through breast milk and may harm nursing babies. Therefore, if you become pregnant while taking Paxil, consult with your doctor to discuss your options. Read about the dangers of Paxil and pregnancy.
Combining With Other Medications
Do not use Paxil if you are using Orap (pimozide), Mellaril (thioridazine), or an MAO inhibitor such as Marplan (isocarboxazid, Parnate (tranylcypromine), Nardil (phenelzine), Azilect (rasagiline, or Eldepryl/Emsam (selegiline).
Serious and sometimes fatal reactions can occur when combining these drugs with Paxil. As a result, it is important to wait at least 14 days after stopping an MAOI before you can take Paxil, and wait at least 14 days before you start taking an MAOI after discontinuing Paxil.
Before taking this medication, inform your doctor if you are allergic to any drugs, if you have liver or kidney disease, a blood clotting disorder, seizures, epilepsy, bipolar disorder, a history of substance abuse, or a history of suicidal thoughts or behaviors.
In addition, Paxil may interact with many other drugs so inform your doctor if you are taking any other medications or supplements. Also, do not begin any new medications or supplements without first informing your doctor.
Combining With Alcohol
It is not recommended that one mix antidepressants with alcohol. Read this Paxil warning about the possible health risks that can occur when combining Paxil and alcohol.