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Zofran Use During Pregnancy Has Been Associated With Cleft Palate

Author Brian Finehout-Henry

A study using data from the National Birth Defects Prevention Study found that use of ondansetron, the generic name for Zofran, during pregnancy doubled the risk of the baby being born with a cleft palate, according to a report from PediatricNews.

About Zofran

Ondansetron, which is sold under the brand name Zofran, was approved by the Food and Drug Administration, FDA, in 1991 for the prevention of nausea and vomiting following cancer treatments.

Zofran, manufactured by GlaxoSmithKline, works to treat nausea and vomiting by blocking a specific serotonin receptor, the 5-HT3 receptor, and is listed by the FDA as a pregnancy category B drugDrugs.com reports that category B drugs lack adequate human pregnancy safety data and that animal studies have not found any adverse effects.

Zofran use during pregnancy to treat morning sickness is “off-label,” this is the term used to describe the use a drug for a purpose not approved by the FDA.

In 2012 the United States Department of Justice announced that GlaxoSmithKline, also known as GSK, had pleaded guilty and paid a $3 billion fine to settle criminal and civil complaints that GSK had illegally marketed its prescription drugs for off-label uses.

A recent study found that during the 2000’s, the off-label use of ondansetron, the generic name for Zofran, during pregnancy increased by more than double and that by 2013, 1 million women per year took ondansetron during pregnancy.

Zofran Use During First Trimester of Pregnancy Linked to Birth Defects

A study conducted by scientists at the Sloane Epidemiology Center and the Centers for Disease Control and Prevention that found using ondansetron during pregnancy increased the risk of the fetus developing a cleft palate by 2.37 times.

This study used data from the National Birth Defects Prevention Study and assessed the risks for non-cardiac birth defects. Two other studies, looking at all birth defects, found that use of ondansetron, generic name for Zofran, during pregnancy increased the risks of a baby being born with a heart defect.

Nausea and vomiting of pregnancy, commonly called morning sickness, typically occurs early in the pregnancy, during the first trimester, and resolves as the pregnancy progresses, according to the American College of Obstetricians and Gynecologists.

Johns Hopkins Medicine reports that during the first trimester, which is the time when women may be prescribed Zofran for morning sickness, is when the fetus is the most vulnerable to developing birth defects.

Surgeries and Therapy Can Be Required to Treat Cleft Palate

The National Institutes of Health informs that cleft palates are birth defects affecting the roof of the mouth. The roof of the mouth forms between the 6th and 9th weeks of pregnancy and a cleft palate occurs when the two parts of the palate do not fuse together, according to the CDC.

The Mayo Clinic reports the following complications with cleft palates:

  • Trouble feeding
  • Reduced weight gain and development
  • Ear infections
  • Hearing loss
  • Dental Problems
  • Problems with speech

The Mayo Clinic reports many different treatments may be required in order to fix the cleft palate and the resulting complications:

  • Multiple surgeries to fix the cleft palate
  • Surgeries to improve cosmetic appearance
  • Surgery to place “tubes” in the ears to address ear infections
  • Hearing aids
  • Speech Pathology

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Teleflex Expands Humidifier Recall

Author Jarod Cassidy

Teleflex has expanded a Class 1 recall for its Maquet Servo 163 humidifiers following the discovery of cracks in some of the devices.

About the Humidifier Recall

The humidifiers are used to warm and humidify gases inhaled by patients who have undergone tracheotomy.

According to Mass Device, the cracks could prevent patients from receiving the correct ofmounts of gases such as oxygen.

Class 1 recalls are reserved for recalls in which the use of a device can result in serious injury or death.

Details of the Recalled Maquet Servo 163 Humidifiers

  • The recall was initially issued on December 4, 2014 and covered only three lots which were distributed in Florida, Kansas, Michigan, and West Virginia.
  • The updated recall, issued January 12, was expanded to cover a total of six lots.
  • The FDA states all the affected lots were manufactured between September 2012 and September 2013.

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Lawsuits Filed in UCLA CRE Exposure Event

Author Jarod Cassidy

Lawsuits have been filed against medical device manufacturer Olympus on behalf of two patients who were infected with a drug-resistant “superbug” while undergoing an endoscopic procedure at UCLA Ronald Reagan Medical Center.

Details of the Olympus Lawsuits

According MassDevice, the lawsuits were filed on behalf of an 18-year-old high school student who remains hospitalized, and another patient, identified as Antonia Cerda, who died of after being infected.

Both patients underwent a procedure which made use of Olympus’ reusable duodenoscope – the lawsuits allege the procedure exposed the patients to Carbapenem-Resistant Enterorbacteriaceae (CRE). The lawsuits further allege Olympus’ duodenoscope is unsafe due to the product’s sterilization protocols not being updated following a recent redesign.

The suits are seeking unspecified damages for Olympus’ alleged fraud and negligence. The plaintiffs and UCLA both maintain that medical staff followed Olympus’ current cleaning protocols.

About the CRE Exposure Event

  • UCLA has notified and sent test kits to 180 patients who were potentially exposed to CRE during endoscopic events.
  • In all, seven infections have been confirmed and two patients have died.
  • CRE infection carries a mortality rate between 40% and 50%.
  • In a similar event that occurred in Seattle in 2012, 32 patients were infected and 11 died.

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