The FDA (Food and Drug Administration) issued a Public Health Advisory in December of 2005 that warned doctors and patients of the potential for Paxil (paroxetine) to cause an increased risk of congenital heart defects in infants due to exposure to Paxil in the womb. This FDA advisory was based upon two separate studies conducted by Swedish and U.S. researchers. Congenital heart defects are just one of the serious birth defects which may result from a woman taking Paxil or other SSRI antidepressants while pregnant.

Paxil Heart Defects

The most common forms of heart defects which may be linked to Paxil include atrial septal defects (ASD) or ventricular septal defects (VSD). These are holes in the walls of the chambers of the heart. Congenital heart defects are treatable when they are caught in time, and your child may then be able to lead a normal, productive life with few related problems. Other known heart defects are: hypoplastic left/right heart syndrome, transposition of the great arteries, patent ductus arteriosus, total anomalous pulmonary venous return, and coarctation of the aorta.

Paxil Birth Defects

There are multiple birth defects associated with Paxil, these include:

• Heart defects
• Persistent pulmonary hypertension of the newborn (PPHN)
• Omphalocele (an abdominal birth defect)
• Hydrocephalus (water on the brain)
• Craniosynostosis (causes the head to be misshapen)
• Clubfoot
• Anencephely (brain defects)
• Neural Tube Defects (Spina Bifida)
• Cleft Lip
• Cleft Palate

Speak to a Paxil Lawyer

If you took Paxil or Paxil CR during pregnancy and your child was born with a birth defect, we encourage you to contact a Paxil litigation attorney at our law firm immediately. It may be too late to recover from the debilitating effects of Paxil, but an experienced product liability attorney can assist you in a legal action against the makers of Paxil. You are not alone. Join other birth defect victims and their families in speaking up and fighting for their legal rights.

Please fill out our free legal evaluation form on the far right and we will call or e-mail you back within 24 hours. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file a lawsuit or seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.

 By Rita Rubin, USA TODAY - 3/13/2005 8:08 PM

Salvatore Ruggiero was puzzled. Over a three-year period, the jaws of dozens of patients who had undergone oral surgery at his hospital had failed to heal properly. Part of the jawbone had died and become exposed.

“We never saw this before in the jaw” except in patients who had received radiation therapy to that part of the face, says Ruggiero, chief of oral and maxillofacial surgery at Long Island Jewish Medical Center. “It just never existed.”

Further investigation revealed one common thread: All of the patients had been treated with at least one of a class of drugs called bisphosphonates.

Most were cancer patients who had received the intravenous bisphosphonates Zometa or Aredia or both for excessive calcium in their blood or bone tumors.

But about 10% were osteoporosis patients who had taken an oral bisphosphonate, mainly Fosamax.

In May, Ruggiero co-wrote a report on 63 patients with osteonecrosis — or bone death — of the jaw in the Journal of Oral and Maxillofacial Surgery. Six had taken Fosamax, and a seventh had taken Actonel, another oral bisphosphonate for osteoporosis.

The problem doesn’t appear to be as severe with oral bisphosphonates as it is with the IV drugs, Ruggiero notes. Patients who have been receiving IV bisphosphonates should avoid having teeth pulled “at all costs,” he says.

Based on his cases, a Food and Drug Administration review posted last week on the agency’s Web site suggests that osteonecrosis of the jaw (ONJ) is a risk of all bisphosphonates, not just the IV drugs.

Bisphosphonates remain in bone indefinitely. Ruggiero speculates that their long-term use could upset the delicate balance between cells that put calcium in bone and cells that take calcium away.

The FDA review concluded that all bisphosphonate labels should mention osteonecrosis.

Novartis, maker of Zometa and Aredia, added a precaution about ONJ to their package inserts in August, although the inserts note that cancer patients have other osteonecrosis risk factors, such as their malignancies.

Merck spokesman Tony Plohoros says his company is in the process of adding information about the ONJ cases to the Fosamax label. And Terri Pedone, spokeswoman for Sanofi-Aventis, which markets Actonel with Procter & Gamble, says, “We are currently addressing the FDA’s request to update the label” with information about ONJ.

Rugierro says he has now seen a total of 12 or 13 cases of ONJ in patients treated with an oral bisphosphonate. Robert Marx, chairman of the division of oral and maxillofacial surgery at Florida’s University of Miami, says he’s aware of at least 40 or 50 cases of ONJ nationwide in patients who had taken Fosamax.

That’s a infinitely small fraction of the approximately 3 million women in the USA who are taking the drug, although most experts agree that only 1% to 10% of adverse events linked to drugs are reported.

Interestingly, some doctors have prescribed IV bisphosphonates “off label” for osteoporosis. And Roche and GlaxoSmithKline announced in December that they are seeking FDA permission to market an IV form of their oral bisphosphonate, Boniva, for osteoporosis.

Fosamax (alendronate sodium) is an osteoporosis drug manufactured by Merck to treat bone loss. Fosamax is prescribed to millions of people to reduce the risk of bone fractures, primarily involving the hip. Hundreds of Fosamax lawsuits have already been filed by consumers who experienced severe side effects from taking Fosamax. These side effects included a rare decay of the jawbone known as osteonecrosis of the jaw, or ONJ.
Updated: March 9, 2010 — Recently, a medical study linked Fosamax to a rare type of bone fracture in the femur.

Fosamax Osteonecrosis of the Jaw (ONJ) Lawsuits

A significant number of Fosamax lawsuits have been filed on behalf of patients who have experienced a severe Fosamax side effect known as osteonecrosis of the jaw, ONJ or “Dead Jaw.” Osteonecrosis of the jaw is a condition marked by pain, swelling, infection, exposed bone and potential deterioration of the jaw bone, oftentimes requiring the removal and reconstruction of the jaw.

For more Fosamax information, see also: Fosamax Osteonecrosis of the Jaw Lawsuits

Fosamax Femur Fractures Lawsuits

A medical study in the Journal of Orthopedic Trauma links Fosamax to a rare type of fracture in the femur. The study looked at 70 patients who experienced low-energy femur fractures, which occur when someone falls from a standing height or less. Of the 70 patients with fractures of the femur, twenty-five of the patients (36%) were taking Fosamax for and average of four years or more.

For more Fosamax information, see also: Fosamax Femur Fracture Lawsuits

Speak to a Fosamax Lawyer

If you took Fosamax and suffered osteonecrosis of the jaw (ONJ), a broken leg, or femur fracture, we encourage you to contact a Fosamax attorney at our law firm immediately. An experienced product liability attorney can assist you in a legal action against the makers of Fosamax. Contact our law firm and learn more about your legal rights and the options available to you and your family.