Showing posts about "recall"
British pharmaceutical company SmithKline Beecham merged with other companies into GlaxoSmithKline. They developed paroxetine and acquired approval from the U.S. Food and Drug Administration (FDA) as Paxil in 1992. The drug comes in two versions: an oral tablet with 10mg to 50mg of paroxetine, and in an oral suspension formulated with 10mg paroxetine per 5mL. As per 2006 records, doctors have filled out 19.7 million Paxil prescriptions.
Paxil is a very powerful concoction under the Selective Serotonin Reuptake Inhibitor (SSRI), a classification of antidepressants. SSRI's work by preventing human brain receptors in absorbing released serotonin. Serotonin aids people maintain a "happy" countenance. Preventing its re-absorption weakens negative feelings. Nonetheless, SSRIs can take several weeks to take effect among users. In such a long process, they lead to many side effects. Particular to these risks are nausea, somnolence, and sexual side effects. However, Paxil does not cause serious weight gain like other SSRI's.
In a corporate data, Paxil sales have reached $1 billion in 2007. As Paxil's side effect becomes well known, the FDA required more stringent product warnings and prescription requirements. The regulation culminated to an October 2004 "black box" Paxil warning. On the other hand, there has been a lack of effort to remove the product from distribution. Not even did the FDA issue a Paxil recall announcement. In the legal arena, GlaxoSmithKline has been deluged with numerous Paxil lawsuits, some of which has been consolidated into Paxil class action lawsuits. One Paxil lawsuit is based on GlaxoSmithKline's promotion of the drug targeting children under 18. In 2008, this particular lawsuit was settled for $40 million. A hundred more Paxil lawsuits, involving birth defects, were settled in July 2010, for a total of $1.14 billion.
In another report, Paxil is found to cause numerous birth defects, injuries, and other complications, particularly during the first trimester of pregnancy, such as miscarriage, withdrawal symptoms (e.g. breathing difficulties, turning blue, low blood sugar, jaundice, changing body temperatures, feeding problems, convulsions, vomiting, floppiness, stiffness, irritability, jitteriness, abnormal crying, and tremors), clubbed foot, cleft lip or palate, delayed development, Persistent Pulmonary Hypertension (PPHN), gastroschisis, enlarged heart, septal heart defects, left outflow tract heart defects, macrocephaly, craniosynostosis, neural tube defects, and spina bifida.
On top of its dangers posed to unborn infants, Paxil has been discovered to cause two other significant side effects: increased suicidal tendencies, and complications among users with pre-existing heart conditions. As a result, the FDA ordered antidepressant manufacturers, including GlaxoSmithKline to include pertinent warnings in Paxil labels.
In a recent study conducted by Duke University researchers, it was concluded that those with coronary artery disease have the greater chance of fatal risks per Paxil use. The researchers, however, could not pinpoint the reasons for the connection. Nonetheless, the findings are compellingly significant.
Those who are considering legal moves against Paxil manufacturers are up for a big challenge. Legal experts are necessary in Paxil lawsuits as the chances of winning compensation cannot be achieved without help from product liability experts.