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Depakote Archives - Carey Danis & Lowe

FDA Announces 10 Drugs With Severe Birth Defect Warnings

By | Pharmaceutical litigation, Uncategorized

Posted January 10, 2012 

San Diego, CA — (SBWIRE) — 01/10/2012 The drugs found on this list went through multiple tests, research experiments, and survey before the FDA classified them as dangerous to babies during pregnancy.

Zoloft (sertraline), a popular antidepressant known as a “selective serotonin reuptake inhibitor” (SSRI), is linked to dangerous side effects in users and serious birth defects (including, heart murmur, hole in the heart and other serious heart defects) if taken by pregnant women. Since 2006, the FDA has warned against the use of Zoloft and other SSRIs in pregnant mothers.

Paxil (paroxetine), one of the most widely prescribed SSRI’s for depression in adults has also been associated with serious side effects in men and women and very dangerous birth defects like heart defects that can result in death if taken by pregnant women. Also part of the 2006 study of SSRI side effects, Paxil has been identified by the FDA to be dangerous for women who are pregnant or who become pregnant.

Prozac (fluoxetine) is probably the most popular anti-depressant and SSRI prescribed by physicians over the past decade and is considered by the FDA to be highly dangerous for women who are pregnant or may become pregnant. Side effects of Prozac include heart defects, cleft palate/cleft lip, and persistent pulmonary hypertension in newborns (PPHN).

Celexa (citalopram), one of the more recent brand-named SSRI’s used to treat depression, was identified by the FDA in 2011 as being linked to very serious side effects as well as birth defects. The FDA issued a warning to adults who took higher dosages of Celexa that they are at a greater risk of deadly heart conditions including fatal heart rhythm problems. Consumer Reports released an article on the study as well.

Wellbutrin (bupropion hydrochloride), was identified by the FDA in 2009 to have links to dangerous side effects and potentially fatal birth defects. A public health advisory was released by the FDA pointing out that Wellbutrin, Chantix and Zyban may increase the risk of suicide and serious neuropsychiatric symptoms.

Lexapro (escitalopram oxalate) is prescribed by doctors to treat depression and generalized anxiety disorder and is in the group of medications classified as SSRIs or selective serotonin reuptake inhibitors. Similar to Zoloft, Paxil and Prozac, Lexapro has been linked to serious and dangerous side effects including thoughts of suicide in adults and heart defects in children from mothers who have taken these products.

Effexor (venlafaxine) is an antidepressant and anti-anxiety drug that was approved by the FDA and released on the market in 2004 as an another SSRI. Since then it has been shown to have a direct correlation with permanent and dangerous birth defects including abdominal birth defects, anal atresia, cardiac defects, limb defects and genital defects.

Diflucan (fluconazole), a powerful anti-fungal medication prescribed to women with yeast infections and other types of fungal infections in the body and organs, may be associated with rare but very serious side effects and birth defects in infants whose mothers were treated with Diflucan. The FDA reported the following possible birth defects: mis-shaped head, cleft palate/cleft lip, joint deformities and congenital heart disease and heart defects.

Topamax (topiramate) is an anti-seizure drug used to treat epileptics and is also prescribed for adults suffering migraine headaches. In 2011, the U.S. Food and Drug Administration strengthened their warning based on new data that links Topamax to severe birth defects when used while pregnant. If you or someone you know has taken or is currently taking Topamax, it is strongly urged by the FDA to discuss alternative treatments for seizures and migraines.

Depakote (divalproex sodium), another popular anti-seizure drug prescribed by doctors to treat epileptic seizures, has been reported in some studies to be linked to severe birth defects and side effects. Birth defects identified in these studies include: holes in the heart, abnormal skull formation, cleft palate/cleft lip, and spina bifida.

If you or someone close to you have taken any of the above drugs and have experienced any of the following birth defects contact a Birth Defect Attorney immediately to discuss your options.

  • Hole in Heart
  • Heart Defects
  • Cleft Lip/Cleft Palate
  • Club Foot, Fetal Death
  • Anal Atresia
  • Hypoplastic Left Heart Syndrome (HLHS)
  • Hypoplastic Right Heart Syndrome (HRHS)Lung Disease/Pulmonary Hypertension
  • Limb Defect/Genital Defect
  • Ventrical Outflow Defect
  • Atrial Septal Defect (ASD)
  • Tetralogy of the Fallot
  • Transposition of the Great Arteries
  • A Ventrical Septal Defect (VSD)
  • Pulmonary Hypertension in newborn (PPHN)
  • Additional Conditions Included…

Anyone who has taken any prescribed medications during pregnancy should discuss their options with a licensed birth defect lawyer immediately. They may be entitled to financial compensation.

Defective Drugs Trigger Avalanche of Lawsuits

By | Pharmaceutical litigation, Uncategorized

Published April 20, 2012 on LawsuitInformation.org

A lawsuit against drug manufacturer Pfizer is simmering in St. Louis, bouncing between state and federal courts while judges decide who will have the pleasure of trying the case. The class action suit is on behalf of 21 mothers who contend that their children were born with birth defects caused by the antidepressant drug Zoloft, which is made by Pfizer.

This particular lawsuit was filed in February and is still in its early stages. However, it is but the latest addition to a disturbing number of prescription drugs which are the subject of litigation due to the serious side effects they cause. Antidepressants in particular have been under fire for causing severe birth defects, up to and including fetal death.

Every drug has side effects, and consumers have the right to frank and accurate descriptions of the risks involved before they start taking a pharmaceutical product. Unfortunately, the trend has been for marketers and manufacturers to downplay or cover up the potential side effects of their wares, with sometimes disastrous results.

“Some haphazardly constructed and advertised medications are contributing to ailments that are much more difficult to overcome than the patient’s original health problem,” says John Bisnar, an attorney at California personal injury firm Bisnar Chase. “As more drug defect victims continue to come forward with debilitating injuries, more pharmaceutical manufacturing companies are being hit with large settlements and verdicts.”

Crippling Side Effects

“If you take medication, avoiding side effects is nearly impossible,” Bisnar says. “Mild side effects are of little concern, but what may seem to be a mild side effect may turn out to be something that is life-threatening. The best way to tell which is which is by keeping track of the medications that have received numerous complaints across the globe.”

A number of medications are currently the subject of lawsuits:

  • Reglan, an acid reflux drug, can cause Tardive Dyskinesia, a permanent neurological disorder characterized by involuntary facial and limb movements.
  • Actos is a diabetes medicine that has been linked to bladder cancer.
  • The painkiller Darvocet was removed from the market in 2010 after the FDA found that use of the drug can lead to heart problems and death.
  • A drug used to treat seizures and migraines, Topamax, has been found to cause birth defects like cleft palate.
  • Use of Effexor, an antidepressant, can cause heart and lung defects in babies.
  • People using Accutane to treat severe acne could be subject to liver disease, depression, ulcerative colitis and birth defects.
  • Fosamax is a drug used to treat osteoporosis but can cause a number of side effects, such as rashes, numbness, loose teeth, jaw collapse and fractured femurs.
  • The antibiotic Levaquin has been implicated in tendon ruptures. A 76-year-old plaintiff from Minnesota won $1.8 million from manufacturer Johnson & Johnson in 2010, and many more suits are pending.
  • Depakote, used to treat manic depression, has been found to cause a range of birth defects, some mild but others as serious as skeletal deformation and fetal death.
  • Another antidepressant, Lexapro, can also cause abdominal, cranial and heart-related birth defects.
  • Paxil, yet another drug used to treat depression, is linked to a laundry list of side effects for adults and newborns, all the way from dry mouth and gas to seizures, bleeding and serious heart and lung defects. As of July 2010 manufacturer GlaxoSmithKline had already spent $1 billion to resolve 800 claims of birth defects.
  • The diabetes drug Avandia, another GlaxoSmithKline product, has sparked more than 13,000 lawsuits due to its propensity for causing heart attacks.
  • A blood-thinning product called Plavix, designed to reduce the risk of heart attacks, has come under fire for actually increasing the chance that patients could suffer from heart attacks, strokes or other ailments.
  • A lawsuit over the hormone replacement drug Prempro was settled last fall after Pfizer faced a $73 million verdict for three women who said the drug gave them breast cancer. Nearly a thousand other claims are still pending.
  • Yaz, a relatively new hormonal birth control product, is alleged to cause heart attacks, strokes, blood clots, pulmonary embolisms, and gallbladder disease.
  • Cholesterol medicine Zocor is facing lawsuits claiming that the drug causes a deadly muscle disease called Rhabdomyolysis.

Abbott to Pay $1.6B to Settle Depakote Claims

By | Depakote, Pharmaceutical litigation, Uncategorized

The following article was originally published on May 8, 2012 by Chicago Tribune.

Abbott Laboratories said Monday it will pay $1.6 billion to settle federal and state claims that it illegally marketed the anti-seizure medication Depakote for uses not approved by the Food and Drug Administration.

As part of the settlement agreement, North Chicago-based Abbott said it would pay $800 million to resolve civil cases brought by federal and state governments, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters.

The company will to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. Abbott also agreed to a five-year probationary period in which it must report any probable violations of the law to the probation office, according to the U.S. Department of Justice.

Illinois Attorney General Lisa Madigan said the state will receive $20 million as part of the deal.

The settlement was expected by investors. Last year, Abbott earmarked $1.5 billion to cover projected costs of the settlement, and set aside another $100 million in April for the same purpose.

Shares of Abbott finished Monday up 10 cents, at $62.51.

Abbott, Chicagoland’s largest company as measured by market capitalization, plans to spin off its legacy drug business into a separate, publicly traded firm called AbbVie this year. It said in a release that certain compliance measures and certification requirements will transfer to the new company.

“We are pleased to resolve this matter and are confident we have the programs in place to satisfy the requirements of this settlement,” Abbott General Counsel Laura Schumacher said in a statement.

“The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements,” Schumacher said.

Depakote, an anti-seizure and mood-stabilizing drug, was first approved by the FDA in 1983 to treat certain seizures in adults and children older than 10. Since then, the drug has been approved to treat other types of seizures, manic episodes of bipolar disorder and for the prevention of migraine headaches.

The Justice Department said in a release that the company illegally marketed Depakote for uses including for treatment of schizophrenia, agitated dementia and autism.

Though doctors can prescribe drugs “off-label,” as the practice is known, companies are prohibited from marketing them to treat conditions that are not approved by the FDA.

Abbott said it had been under investigation for four years in connection with the sale and promotion of Depakote stretching back to 1998.

The investigations led by the federal government and states’ attorneys general were based partly on whistle-blower lawsuits filed in federal courts in Illinois, Virginia and the District of Columbia that accused Abbott of illegally promoting Depakote. Those suits also alleged that the company gave doctors and pharmacists illegal kickbacks to talk about off-label uses of the drug to boost sales.

The first suit, filed in 2007 by former Abbott saleswoman Meredith McCoyd, accused the drug maker of encouraging her and other salespeople to promote the drug in nursing homes and public mental health centers, where most patients were covered by federal health care programs, including Medicaid.

The Justice Department intervened in those suits to determine whether the company’s marketing of the drug violated civil and criminal laws.

In a release, the Justice Department said Abbott admitted that from 1998 to 2006, it “maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use.”

From 2001 to 2006, it said, the company marketed the drug for use in combination with anti-psychotic drugs to treat schizophrenia, though its own clinical trials showed Depakote provided no benefit.

“Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud,” said James M. Cole, Deputy Attorney General. “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

The Abbott settlement is one of a string of recent enforcement actions pursued by the FDA, which has ramped up its investigation of off-label drug marketing, ensnaring several other large drugmakers within the last several years.

In November, GlaxoSmithKline PLC said it would pay the U.S. government $3 billion to settle civil and criminal charges for illegal marketing of diabetes drug Avandia and others.

In 2009, Pfizer Inc. paid $2.3 billion for similar allegations about its painkiller Bextra, and Eli Lilly & Co. settled for $1.4 billion the same year for Zyprexa, used to treat schizophrenia.