Treatments Sometimes Cause Serious Health Conditions

One drug that is included in the World Health Organization’s list of medicines necessary in the basic health system and which, in 2006, became one of the top selling drugs in the US, is Zofran. Generically known as Ondansetron, Zofran was formulated to prevent and treat nausea and vomiting in patients who have just had surgery, radiation therapy or cancer chemotherapy – the same purpose for which this drug was approved by the US Food and Drug Administration in 1991.

Due to Zofran’s efficacy in blocking serotonin, a natural substance inside the body that causes vomiting, its manufacturer, London-based GlaxoSmithKline (GSK), confidently endorsed it for off-label use, specifically for relief from morning sickness, which pregnant women feel during the first trimester of their pregnancy. Aside from this, GSK, as affirmed by the US Department of Justice, also rewarded doctors who prescribed Zofran for morning sickness.

One major issue that involved GSK, Zofran and pregnant women (even prior to Zofran being recommended to treat morning sickness) was the fact that GSK had never tested Zofran on pregnant women, thus the absence of records which will show if the drug is actually safe or harmful to the mother or her unborn child or to both. It seems, however, that the truth behind this issue of being safe or harmful has been known by GSK as early as 1992 due to lawsuit based on birth defect that was filed against it. Despite this knowledge, said manufacturer continued to promote Zofran to treat morning sickness.

There are many different side effects linked to Zofran, including swelling of the body, fainting, difficulty in breathing and/or swallowing, drowsiness, tiredness, dizziness or lightheadedness, constipation, headache, and irregularity in heartbeat. However, none of these side-effects can outweigh the severity of harm which is birth defect (such as cleft palate, cleft lip, or congenital heart defects) which also happens to be the basis of so many lawsuits against GSK.

There are many other things that Zofran users need to understand about this drug, including details about the birth defects linked to it, its history with the FDA, what this product really is, and the legal rights of individuals harmed by it. Information about other defective pharmaceutical products can be found at www.williamskherkher.com/practice-areas/defective-pharmaceuticals/.

While it is the duty of drug and medical supply manufacturers to ensure the effectivity and safety of all their products, they are not given the right to market these products for off-label use. Even if a product is intended as treatment for only one type of health condition, manufacturers still have the legal and moral obligation to test it to clearly determine who can use it safely and who can be harmed by it.

It is alarming, therefore, to know that tens of thousands of patients remain to be harmed either by prescription drugs or medical devices every year. Zofran is just one of the hundreds of drugs found and proven to cause adverse effects; with regard to medical devices, one recently identified harmful product is the power morcellator, a medical device designed to cut large tissues into tiny pieces.

Morcellators were introduced in the 1990s and were intended to aid physicians perform a laparoscopic surgery (such as hysterectomy and myomectomy) that is as painless and bloodless as possible, besides being a fast procedure. Furthermore, unlike in open surgery, the traditional way of performing surgeries, an abdominal incision that was about six to nine inches long is required, while in a laparoscopic surgery, which is a minimally invasive procedure and which makes use of a morcellator, four very tiny incisions, each measuring about 0.5 – 1cm. are all that is required.

Myomectomy is the surgical removal of fibroids from the uterus, while hysterectomy is a procedure wherein the entire uterus, or womb, is removed due to any of the following conditions:

  • Cancer of the uterus, cervix, or ovaries
  • Severe pains due to endometriosis, a condition wherein the tissues lining the uterus grow outside of it instead or in an abdominal or pelvic organ, like the ovary, or fallopian tube
  • Uterine prolapse, a condition wherein the uterus drops into the vagina as the tissues that hold it in place have become weak
  • Growth of large uterine fibroids (or benign/non-cancerous tumors) which cause bleeding, chronic pelvic pain, and bladder pressure
  • Pelvic inflammatory disease
  • Adenomyosis, a condition wherein the wall between the lining of the uterus (called endometrium), and the uterus’ muscle is broken, causing the endometrial glands to grow into the uterus’ muscle; this further results to the enlargement of the uterus

Despite the benefits and advantages provided by morcellators, the US Food and Drug Administration issued a safety communication notice to doctors on April 17, 2014, to discourage them from the further use of the device in surgical procedures, especially in fibroids removal through myomectomy. Morcellators, as studies show, caused the development of leiomyosarcoma, a deadly type of cancer, during the morcellation/cutting of these fibroids. The actual reason behind the development of leiomyosarcoma is the spread of the almost undetectable cancerous tissues called uterine sarcoma, which usually grows with fibroids and which also gets cut into very small pieces (along with the fibroids).

The first company to respond to the FDA’s safety communication notice was Ethicon, a unit of Johnson & Johnson and which happens to be the largest manufacturer of power morcellators around the globe. While Ethicon’s move to cease the manufacture, promotion and sales of its morcellators may be considered as a really positive move, it may have come late as thousands of women have already been treated with the device.

Definitely, not all of those who have been treated with a morcellator will develop leiomyosarcoma since not all those with fibroids also have uterine sarcoma. For those who have been diagnosed with the deadly cancer, however, consulting with a morcellator lawsuit attorney may be in their best interest. A website with address, www.williamskherkher.com/practice-areas/defective-pharmaceuticals/morcellators/ offers substantial information which someone diagnosed with leiomyosarcoma may just want to know.

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