More recently, pregnant woman and those planning a pregnancy were also warned to avoid taking Paxil, generically paroxetine, because of an increased risk of birth defects, particularly cardiac defects.
Additionally, the maker of Paxil, GlaxoSmithKline, has said that analyses from clinical trials showed the drug appeared to increase the risk of suicide among woman younger than 30. The possibility of increased "suicidal thoughts" has also been noted among children taking antidepressants and, most recently (in December 2006), a government panel suggested extending the suicide-risk warning on antidepressant drugs to include patients into their mid 20s.
And in yet another development, these antidepressants, part of a group known as selective serotonin reuptake inhibitors, or SSRI medications, have been shown to double the risk of bone fractures among patients 50 and older.
Lung conditions. The study citing lung problems with the use of Paxil, Prozac, Zoloft and Celexa was published in the Feb. 9, 2006 issue of in The New England Journal of Medicine. It noted the potentially deadly condition -- persistent pulmonary hypertension, or PPHN -- occurred six times more often among newborns whose mothers took the antidepressants in the second half of pregnancy.
While rare, the lung condition is very serious. According to one report, some 10 to 20 percent of infants with PPHN die even if they receive treatment. Many others suffer severe injuries such as major brain abnormalities and hearing loss.
The antidepressant study included 377 women whose infants suffered PPHN and 836 whose infants did not have the ailment, then compared medications taken by the women. The study found that infants were 6.1 times more likely to have suffered PPHN if their mothers had taken the antidepressants after the 20th week of pregnancy.
Prozac is manufactured by Eli Lilly, Zoloft by Pfizer, Paxil by GlaxoSmithKline, and Celexa by Forest Laboratories. There are also a number of generic equivalents for several of the drugs on the worldwide market.
The antidepressants cited in the study are all serotonin-reuptake inhibitors, or SSRI drugs. They are commonly prescribed, with sales of Prozac, Zoloft and Paxil reaching roughly $7.5 billion in 2005. Prozac alone has been prescribed to an estimated 35 million people since it hit the market some 20 years ago. (Read USA Today article.)
Birth defects: The American College of Obstetricians and Gynecologists has issued an opinion that use of Paxil "should be avoided, if possible" among pregnant women or women planning pregnancies.
The pronouncement in the December 2006 issue of the journal Obstetrics & Gynecology followed a news release by the U.S. Food and Drug Administration issued almost a year earlier alerting doctors and patients that Paxil was found in two studies to increase the risk for birth defects, particularly heart defects, among women in the first three weeks of pregnancy.
One study, from Sweden, showed that women who took Paxil in early pregnancy were twice as likely to give birth to babies with a heart defect as were women who took other antidepressants or none at all. Another study conducted in the United States showed 1.5 times the risk of cardiac defects and a 1.8-fold increased risk of congenital malformations.
Most of the heart defects reported were atrial and ventricular septal defects, or holes in the walls of the heart chambers. Some of the fetal heart defects healed without treatment but others were more serious, requiring surgery.
The FDA asked GlaxoSmithKline to reclassify Paxil as a Class "D" drug for pregnant women, signifying that studies in women showed a risk to the fetus. The classification is the second-highest category for risk of birth defects. (Read article: ABC News)
Suicide: The FDA issued an alert in July 2005 warning that antidepressants, including Paxil, may increase suicidal thoughts and actions, particularly among younger patients. One analysis of nine different antidepressant medications showed double the rate of "suicidal thinking" among children who used antidepressants as opposed to those taking a placebo.
The FDA said antidepressants may increase such suicidal tendencies in about on in every 50 people who are 18 years old and younger. In addition, an FDA advisory panel in December 2006 recommended that the suicide-risk "black box warning" on antidepressant drugs – currently pertaining to children and adolescents -- be extended to cover young adults up to their middle 20s.
The FDA cited several scientific publications also reported the possibility of an increased risk of suicidal behavior among adults who were treated with antidepressants. The agency said it was conducting a complete review of all available data to determine if there is a link between antidepressants and suicidal behavior in adults.
Evidence of a link between antidepressants such as Paxil and other similar drugs (including Prozac, Zoloft and Zelexa) is disputed. One recent study funded by the National Institute of Mental Health showed a decrease in actual suicide attempts among patients who took antidepressants in the six months after they began using the drugs. (See article.)
Bone fractures. Daily use of SSRIs doubled the risk of a minimal-trauma fracture in older patients, according to a study reported in the Jan. 22 issue of the Archives of Internal Medicine.
Researchers who conducted the study said the findings were important because a large number (about 10 percent) of people older than 50 suffer depression and SSRI drugs are often a first-line treatment.
The drugs used in the study included Paxil, Prozac, Zoloft, Celexa and Luvox.
The most common fractures experienced by the patients in the study were to the forearm (40 percent), followed by ankle and foot (21 percent), hip and ribs (13 percent), femur (9 percent) and back (4 percent).
Do not suddenly stop taking antidepressants. Pregnant women taking the antidepressants were advised to consult with their doctors and not to simply discontinue the medicine since suddenly stopping antidepressant therapy can cause negative withdrawal effects.
Kline & Specter, PC, is one of the nation's leading pharmaceutical injury litigation law firms. However, at this time, we are no longer accepting cases involving antidepressant drugs.