Jun 11, 2015

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History of the FDA and Power Morcellators

The Food and Drug Administration (FDA) is typically prominent when it comes to dangerous drugs, medical devices, and consumer products. It is, after all, the regulatory body that approves the introduction of these products to the general public. This includes medical devices such as power morcellators, that it cleared for medical use for the first time in 1991. In that particular instance, events unfolded that prompted the FDA to stand and take notice.

More than two decades after giving it the go-ahead, the FDA has issued a succession of safety communications to the public regarding the dangers of laparoscopic power morcellators for hysterectomies and myomectomies. By this time, the instrument had become commonly used, and thousands of women exposed.

The first warning came in April 2014, which discouraged doctors from recommending morcellation for these routine procedures, and manufacturers from marketing it. The data they analyzed indicated that one out of 350 women on which the morcellators are used develop uterine sarcoma. It is speculated that it resulted from cutting up unsuspected sarcomatous (cancerous) uterine fibroids. Immediately following this warning, Johnson & Johnson stopped sales of its laparoscopic power morcellators.

In July 2014, the FDA consulted with the Obstetrics and Gynecology Devices Panel to determine the at-risk populations with the use of morcellators. The discussion also revolved around how to mitigate these risks.

An Immediate in Effect second warning was released on November 24, 2014, and this time included recommended labeling guidelines for boxed warnings and safety statements on contraindications. The boxed warning specifically stated that unsuspected cancer cells may be lurking in uterine tissue, and that open morcellation can speed up its spread. Specifically, it should not be used for the removal of uterine fibroids in post- or peri-menopausal patients, or any gynecological procedure where cancer is suspected.

According to a website about morcellator lawsuits, however, the manufacturers should have known about these dangers much earlier in the day. The FDA warnings came out much too late for thousands of women that have succumbed or currently suffering the consequences of this oversight. If they had known the risks they were taking, they would probably have elected for a different way of getting the surgery done.

If you acquired uterine sarcoma or other complication linked to power morcellators, you may be a candidate for a dangerous product lawsuit. Consult with a morcellator lawyer in your area and find out more.

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Apr 16, 2015

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The Dangers Associated with the Use of Zofran

Before a drug gets approved by the US Food and Drug Administration for distribution, its manufacturer will first need to prove through tests that it is safe and effective and state the risks associated with its abuse or wrong use.

One particular drug that was approved by the FDA is Zofran, with generic name Ondansetron, for the prevention and treatment of nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Manufactured by London-based GlaxoSmithKline, this effective antiemetic agent belongs to a group of medicinal pills known as 5-HT3 receptor antagonists, which block serotonin, the body’s natural substance which can cause vomiting.

Zofran is included in the list of medicines that are necessary in the basic health system; this list was prepared by the World Health Organization. In 2006 it also became the 20th highest-selling drug in the United States.

Due to Zofran’s efficacy in treating the condition it was approved for, its manufacturer became confident enough to recommend the drug even for non-label use. Even doctors followed suit, prescribing the drug to pregnant women, especially those who are on their first trimester of pregnancy, to relieve them of the discomfort caused by severe morning sickness.

Besides not being meant to treat the vomiting experienced by pregnant women, a very natural occurrence during the first three months of pregnancy, Zofran has never been tested on pregnant women, thus, the absence of notes that would show whether the drug is safe or can cause risks to the mother and her unborn child.

The adverse effects of Zofran soon became evident, though, as different types of birth defects all began to be linked to the drug. According to the website of the Zofran lawsuit attorneys at Williams Kherkher, these include heart ailment, cleft lip, cleft palate, mouth deformities, musculoskeletal anomalies, and others.

Birth defects are not the only complaints about Zofran, however, for other patients also complain of irregular heartbeat, dizziness, swallowing difficulties, body swelling, shortness of breath, rashes, and so forth.

Prescribing Zofran for off-label use, despite the absence of proof regarding its total safety, can be seen as an example of medical malpractice, which claims about 225,000 lives in the US annually. According to the website of law firm Habush Habush & Rottier S.C. ®, medical malpractice victims have a right to pursue justice and file a case against the liable doctor.

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