Defective Drug News: 3 Drugs Currently Under Scrutiny

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When it comes to your health, you can never play it too safe. If you’re behind on defective drug news, read on to learn about the three most scrutinized drugs this year.

Xarelto – Bayer and Johnson & Johnson

This blood thinner is the subject of over 5,000 lawsuits involving 500 patient deaths. The Food and Drug Administration approved the drug after 14,000 patients participated in a three-year clinical trial. The results of that study are now highly suspect since one of the blood-testing devices apparently malfunctioned.

Anticoagulants prevent clotting and keep blood flowing to vital organs. Doctors normally prescribe in doses specific to each patient, but Xarelto is sold in just one uniform dose.

Below are some of the injuries and complications at the heart of the lawsuits:

• Uncontrolled bleeding resulting in death
• Intestinal, rectal and internal bleeding
• Hospitalization
• Stroke
• Brain hemorrhaging
• Anemia
• Embolism
• Blood clots
• Leakage and infection requiring surgery after knee or hip replacement

It might be one of the biggest names in defective drug news, but Xarelto boasted almost $2 billion in U.S. sales in 2015. The FDA recently rejected a proposed antidote for the drug.

Taxotere – Sanofi-Aventis

Taxotere is a chemotherapy drug prescribed primarily for breast cancer. Last year, the FDA forced the manufacturers to include its most serious package warning. Using Taxotere may result in permanent hair loss, a condition called alopecia.

Patients can expect hair loss during treatment, but it’s almost always temporary. According to one study, more than 9 percent of patients treated with Taxotere suffered alopecia that lasted at least 10 years. Even eyelashes and eyebrows are affected, and the damage appears to be irreversible.

In a growing number of lawsuits, patients claim that they were not warned about the severity and permanence of their hair loss. Alopecia is a devastating disfigurement, especially for women. Depression is already a problem for chemo patients. When embarrassment, poor self-image and loss of confidence are added to the mix, healing can be adversely impacted.

Taxotere is not without other negative side effects that occur in up to 30 percent of patients:

• Nausea
• Diarrhea
• Fluid retention, weight gain and swelling
• Mouth sores
• Discoloring or loss of nails
• Anemia
• Numbness
• Joint, bone or muscle pain

Zofran – GlaxoSmithKline

Women will try just about anything to get through the first weeks of pregnancy. Nausea and vomiting can range from mild to quite severe. At worst, dehydration and malnutrition pose a threat to both the baby and the mother.

Zofran and its generic variety, ondansetron, were only approved for patient use following surgery, radiotherapy and chemotherapy. Doctors, however, soon began prescribing them for unapproved uses. When the manufacturer learned that they were being used to treat morning sickness, it began to market Zofran for that purpose. Sales skyrocketed to hundreds of millions of dollars a year even though the FDA had never given the green light.

Over the last few years, Zofran and spinoff drugs have been linked to congenital birth defects in the children of mothers who took them. Lawsuits against GlaxoSmithKline allege that the maker lied about the risks of taking Zofran during pregnancy. The labeling indicated that it posed no danger to humans, but a number of studies have resulted in evidence to the contrary.

Serious birth defects linked to Zofran include the following:

• Heart dysrhythmia
• Mental Problems
• Vision and hearing problems
• Webbed toes
• Cleft lip or palate
• Skull deformities

For your safety and the safety of your family, it pays to stay informed and keep up with defective drug news.


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