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Special Warning Regarding Hazardous Drugs and Products

We’d like to take the time to do you a favor, and tell you about a few of the harmful drugs and products that are currently circulating on the medical market. If you didn’t already know, the popular anti-depressant drug Paxil has been linked to severe birth defects, and taking the anti-diabetic drug Avandia can increase your risk for heart attack.

As far as products are concerned, there was a recent recall on two hip replacement devices made by DePuy Orthopedics & Stryker. The defective designs caused many patients to experience significant pain and other unpleasant symptoms. You deserve to be informed about what you put into your body!

Paxil and Birth Defects

In several extensive studies, the anti-depressant drug Paxil was found to have many severe birth defects on babies with mother’s taking the drug. Premature birth and heart defects were the most frequent.

Premature Birth

Studies have linked mother who take Paxil have a 40% increased risk of premature birth.

Cardiac Defects on the Baby

Studies conducted in the U.S. and Sweden point to an increased risk of Paxil-related cardiac birth defects, in babies whose mothers use the drug during pregnancy.

Women who take Paxil during their first trimester are one and a half to two times more likely to have a baby with a heart defect, than women who were taking other antidepressants or not taking any antidepressant.

Studies have shown that the use of selective serotonin reuptake inhibitor (a class of drugs which includes Paxil) in the first trimester of pregnancy increase the risk of cardiac defects in babies by 60%.

Women who took Paxil in or after their second trimester were six times more likely to have a baby with a rare birth defect known as persistent pulmonary hypertension, or PPHN.

Other Specific Paxil-related Birth Defects Found

  • Heart malformations / congenital heart defects/(VSD)(ASD)
  • Persistent pulmonary hypertension (PPHN)
  • Abdominal defects (Omphalocele
  • Cranial defects (Craniosynostosis)

If You’ve Been Negatively Effected by Paxil, You’re Not Alone!

In July 2010, rather than go to trial, Paxil’s maker GlaxoSmithKline, agreed to pay in excess of $1 billion to settle hundreds of lawsuits over birth defect claims. Who knows how many other families have suffered though.

These settlements came four years after the Food & Drug Administration instructed all antidepressant makers to revise their labels to include the risk these drugs pose to expectant mothers and their babies.

The Harmful Effects of Avandia

I talked about the dangers of Avandia in a recent blog post, but the word needs to be spread more extensively, about just how harmful it is!

What It is

Avandia (or rosiglitazone) is a popular anti-diabetic drug manufactured by the United Kingdom-based pharmaceutical company GlaxoSmithKline.

What It’s Supposed to Do

It is designed to increase the body’s sensitivity to insulin and used to treat type-2, non-insulin dependent diabetes – a serious, life-threatening disease that affects about 18 to 20 million Americans – Avandia has been on the market since 1999.

Cardiac Defects

Since its release, the FDA has been monitoring Avandia’s link to several heart-related side effects (including fluid retention, edema and congestive heart failure).

One study concluded that individuals taking Avandia were 43 percent more likely to have a heart attack. These conditions can all be debilitating, and they can all lead to the death of a patient.

The FDA is advising patients who are taking Avandia – especially those who are known to have underlying heart disease or who are at high risk of heart attack – to talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

Other Specific Avandia-related Side Effects Found:

  • Weight gain
  • Liver problems
  • Anemia
  • High cholesterol, and most seriously
  • Heart Attack

You’re Not Alone!

In 2007, the U.S. Food and Drug Administration (FDA) announced that due to concerns over serious side effects, Avandia® would carry a “black box” warning.

Furthermore, the FDA issued a safety alert on Avandia. This release noted that “safety data controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”

DePuy Hip Replacement Recall

In September of 2010, DePuy Orthopaedics issued a recall of its ASR XL Acetabular System and ASR Hip Resurfacing Platforms.

The recall was brought about by data that showed a revision surgery rate of about 13 percent for those with the ASR XL system and of about 12 percent for those with the ASR resurfacing system, reports the news provider.

DePuy Orthopaedics, issued a voluntary recall of its ASR XL Acetabular System and ASR Hip Resurfacing Platforms that were implanted after July 2003. If a patient had a hip surgery prior to July 2003, those patients are not affected by the recall.

Reasons for the Recall

DePuy cites that the reason for its recall is the unexpected number of complaints of pain and other symptoms by patients who have received either a total hip replacement or an ASR Hip Resurfacing Platform.

DePuy states that their studies have shown that 1 in 8 patients who received the ASR resurfacing device required a second (revision) surgery, while 1 in 8 of patients who received the total hip replacement surgery required a revision surgery.

Common Complaints

The defective design of the ASR hip replacement cup, which is shallower than similar hip replacement devices, is responsible for many of the product’s problems. The ASR hip replacement cup doesn’t always affix to the bone as intended. Too often, this results in a “loose cup” that must be revised, or removed and replaced by a corrective surgery.

The DePuy ASR hip replacement implant is a metal-on-metal hip replacement system. These defective hip implants can shed metal particles and debris into the body as they wear. That debris can cause severe inflammatory reactions in some patients, damaging muscles and soft tissue and lead to bone loss. As a result, a second corrective hip replacement surgery is often required to replace the defective hip device soon after implant.

If you or your loved one has been negatively effected by any of these drugs or products, don’t hesitate to call or contact me to get the justice you deserve. Personal Injury is all we do!

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