A Paxil lawyer can help

Paxil, an antidepressant manufactured by GlaxoSmithKline, has been connected with suicide and other violent acts since before it was approved in December 1992. In fact, SmithKline Beecham’s (as the company was known then) own data, which was submitted to the Food and Drug Administration (FDA), showed that the drug could increase the risk of suicide. But Paxil was approved anyway, and without any warning about this “suicide effect” or any of the other potentially dangerous side effects of Paxil.

As a result, you may need a Paxil lawyer from Jim S. Adler & Associates. Such a Paxil attorney can seek fair and just compensation for you if you or a loved one has been harmed due to Paxil.

There are several disturbing aspects to this. First was the contention that the pharmaceutical company changed the numbers that it submitted to the FDA, which downplayed the risk. The FDA had originally asked SmithKline Beecham to put together a safety assessment of Paxil and the possibility that it could actually increase the suicide risk. This was prompted by reports of Prozac-related suicides, another antidepressant in the same class as Paxil.

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According to the company’s original research data, there were seven suicides and 42 suicide attempts out of 2,963 patients taking Paxil. But in the 1991 review, those numbers changed to five suicides and 40 attempts. The number of suicide attempts in the placebo group doubled from three to six patients. Although this still shows a big difference between the two groups, it does not seem as bad as its original data showed.

In fact, argued one lawyer, given that some of the suicide attempts in the placebo group were during the “wash out” period when they were getting off other drugs before entering this study, the suicide attempts in this group can’t really be counted – the attempts may be the result of withdrawals from the other drugs. Assuming this, Paxil raised the suicide risk nine times.

Of important note though is that this risk is raised only for some people. If doctors and consumers were warned of the possibility that Paxil may increase their risk for suicide and other violent acts, and what symptoms to look for, this could have reduced the risk significantly.

Symptoms like restlessness, increase anxiety, insomnia, and others can be a sign of akathisia, which is sometimes a precursor to violent behavior. The only problem is that they are also symptoms of deepening depression. Doctors who did not realize that Paxil could cause this chain of events assumed that their patient’s depression was worsening and upped the dose of the potentially-deadly drug.

So who’s to blame? Certainly the FDA could have forced the company to include this warning before allowing Paxil onto the market. But ultimately it is the manufacturer who is responsible for the safety of its product, and ensuring that doctors and patients know the risks and most importantly, know the signs of a potentially dangerous situation. SmithKline Beecham knew the data, but chose to downplay the risks rather than alert the public to increase their profits.

If you or a loved one has experienced severe side effects while taking Paxil such as suicidal tendencies or akathisia, contact a Paxil attorney with Jim S. Adler & Associates. Submit the details of your Paxil problems on the form on this page, or contact us directly and we will give you a full and free case assessment. You may be entitled to collect compensation for your medical bills, lost work, and other monetary losses as well as your pain and suffering. Contact Jim S. Adler & Associates right now for a free case review, and find out about your legal rights.

PAXIL ARTICLES...

Paxil birth defects real but low

Two studies published in a June 2007 issue of the New England Journal of Medicine (NEJM) prove that women taking Paxil during pregnancy can increase the risk of birth defects for their children. However, both studies confirm that the overall risk is still very low.

Paxil use in youth: What is the answer?

It is one thing to accept the risks of any medication like Paxil when you yourself are taking them, but it is quite another for parents to assume that risk on behalf of their children. Yet that is what many parents are forced to do – and often they do not have all the information in order to make an informed decision.

Paxil can trigger violence

In June 2001, a Cheyenne, WY jury found that the Paxil manufacturer SmithKline Beecham (now GlaxoSmithKline) was 80% at fault for a quadruple murder/suicide involving a patient who had taken the drug for just two days. Despite years of evidence that these antidepressants can actually cause psychotic episodes, this was the first court proceeding in the United States to prove the connection in an actual case. Although this made it a landmark case in its own right, the facts that it revealed about the company’s own drug testing and results opened many eyes.

Doctors note Paxil risks

After the Food and Drug Administration (FDA) announced warnings about certain antidepressants including Paxil and their possible side effects in younger people, the number of children and teenagers prescribed the drugs dropped dramatically, an April 2007 study found. "Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States," published in the Archives of General Psychiatry, was designed to "provide additional analyses on the prescribing trends of antidepressants across age groups and physician specialties in the United States."

Paxil related to birth defects

After the Food and Drug Administration (FDA) approved Paxil for sale in the United States in 1992, it was categorized as safe for women to take during pregnancy. However, after years of reports of birth defects and congenital malformations, the FDA changed that classification to a Category D, a level that covers all harmful drugs that “have demonstrated a risk to the fetus.” Many women who took Paxil during their pregnancy and lost their babies to severe birth defects are now questioning what role their so-called “safe” medication played in the death of their infants.

FDA assesses Paxil health risks

On July 19, 2006 the Food and Drug Administration (FDA) released a special Public Health Advisory about SSRIs like Paxil and birth defects. Entitled “Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns,” the advisory was the culmination of several studies into one federal policy – and one that many believed was long overdue.

Pregnant women should be wary of Paxil

A group of obstetricians have recently warned pregnant women that Paxil poses possible risks of birth defects in their unborn child and should be avoided.

The opinion issued by the obstetric practice committee of the American College of Obstetricians and Gynecologists comes nearly a year after the Food and Drug Administration and manufacturer GlaxoSmithKline reclassified the drug to reflect studies in pregnant women that showed the drug poses a risk to the fetus.

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