FDA approves generic Zoloft drug Sertaline
Sertraline is used medically mainly to treat the symptoms of depression and anxiety. It has also been prescribed for the treatment of obsessive-compulsive disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, panic disorder, and bipolar disorder. It was first approved by the FDA in 1991. The patent for this brand-name drug expired in December 2005. It is anticipated that the generic drug will be available in the United States in June of 2006, manufactured by Andrx, Aurobindo, Genpharm, Ivax, Mylan, and Roxane. In Scandinavia a generic drug called Sertralin, manufactured by HEXAL is available. The price differences between Zoloft and Sertralin are as high as 1.50 dollars per pill.
Sertraline can have a number of adverse effects, including insomnia, asthenia, gastrointestinal complaints, tremors, confusion, dizziness, anorgasmia, and decreased libido; it can induce mania or hypomania in around 0.5% of patients. It has also been known to cause minorweight loss. It is contraindicated in individuals taking MAOIs or undergoing electroconvulsive therapy.
Until 2003 Zoloft was only approved for use in adults ages 18 and over; that year it was approved by the FDA for use in treating children ages 6 to 17 with extreme obsessive compulsive disorder. In June, 2004, Britain banned the use of Zoloft by minors and in February, 2005, Pfizer was forced to change the labeling of Zoloft to include information regarding increased incidences of suicidal behavior and depression in adolescent users of the drug.
According to mentalhealth.com, Zoloft is not currently recommended or advised for use in individuals under the age of 18. After these changes, multiple incidences and at least one medical study showed an increased risk of suicide in seniors who were taking Zoloft. In response to these findings, the FDA released a public health warning. This warning indicates that anyone currently using Zoloft for any reason has a greater chance of exhibiting suicidal thoughts or behaviors regardless of age. This warning is questionable, however, due to the types of illnesses Zoloft is used to treat, it is impossible to determine if these tendencies are a side effect of the drug or the illness the drug is meant to treat.
Zoloft and Pregnancy
Zoloft has long been seen as the best option for breastfeeding mothers who wish to continue breastfeeding and be able to take their antidepressants. Despite its apparent safety and effectiveness during the breastfeeding period, recent studies and consumer complaints have seen a need to alter Zoloft’s labeling regarding use during the third trimester of pregnancy.
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