Breaking Down the Debate: Is Zofran Safe for Pregnant Women?

A recent news report by Valley News Live brought attention to a 2-year-old girl named Arianah Reisen who was born with a congenital heart defect requiring her to undergo surgery. Her mother, Kylee Riesen, points to the drug Zofran as the main culprit. She tells the news outlet of the time she was prescribed the anti-nausea drug used to treat chemotherapy patients when she suffered from severe morning sickness.

Arianah’s mother isn’t alone in making this assertion. The Zofran lawyers of Williams Kherkher point out on their website that they have been investigating several other cases that show the possible links between the occurrence of serious fetal injuries and the use of Zofran during pregnancy. Aside from congenital heart defects, they found that Zofran could also lead to cleft lip and palate.

With potential risks like these, it’s easy to wonder why Zofran is still a common choice for morning sickness medication. A quick Google search will show conflicting messages about the safety of the drug. One news report will assert that Zofran is completely safe, while another will tell readers to be wary of its dangers. Is there a definitive answer that can end this debate and help ease the anxieties of worried mothers-to-be?

Unfortunately, the short answer is no. While there have been plenty of reports circulating about the dangers of Zofran, the medical community has yet to find a conclusive answer that can help settle this debate. A lot of the scientific research examining the links between Zofran and birth defects has yielded different conclusions. For example, a study published by The College of Family Physicians of Canada in 2012 concluded that using the drug resulted in increased risk of major fetal malfunctions. On the other hand, a study commissioned by Danish Medical Research Council in 2013 found no sufficient evidence to link birth-related issues with the drug. In the same year,

Despite the lack of a conclusive answer, it’s best for pregnant women to err on the side of caution. As a safety precaution, the Food and Drug Administration (FDA) issued a statement warning the public about potential safety issues concerning the drug. It’s important to note that taking Zofran during pregnancy counts as “off-label use”, meaning it was never approved by the FDA for this specific purpose. Medical professionals suggest alternative treatments to treat their symptoms. If you are suffering from severe morning sickness, talk to your doctor about options aside from Zofran.

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Paxil Lawsuits

The first whiff of major trouble that UK-based GlaxoSmithKline (GSK) would have with its paroxetine-based drug Paxil was when a qui tam (whistleblower) lawsuit was filed by four of its employees, including quality manager Cheryl Eckard in 2004. While there had been ripples in the water prior to this, such as the successful Tobin case, this started the ball rolling not only for Paxil but also for other GSK products, finally resulting in a $3 billion bill from the U.S. Justice Department.

The qui tam suit alleged that GSK made false claims of the safety and effectiveness of products included in Medicare and other federal health programs. Eckard had warned GSK about the problems with the manufacture of the products but instead of fixing the problems, she was fired for her efforts. GSK settled the case, paying $750 million in civil and criminal penalties.

Barely had the qui tam case been filed when GSK again came under federal fire for its aggressive marketing campaign of Paxil as a non-addictive drug. Based on numerous reports that Paxil in fact caused withdrawal symptoms prompted the judge to order GSK to cease and desist making misleading and inaccurate claims to the public.

In 2008, GSK was again hauled into court to face allegations of concealing vital information about the adverse effects of Paxil from the government, physicians and patients. There is documentary evidence that GSK knew that paroxetine increased the risk of suicide by 8 times way back in 1989, but only alerted the public in 2006. The investigation leading to this allegation began in 2003, when reports of Paxil-induced teenage suicides began coming in. Although Paxil is not approved for pediatric use, GSK had been actively marketing the drug to physicians for child depression. In 2004, the Food and Drug Administration required Paxil to have a black box warning regarding the risk of suicide for teens.

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Redness, Vessels & Rosacea: Symptoms, Sub-types are Treatment

While many individuals worry about wrinkles and smile lines or nasolabial folds, both of which are part of the aging process, so many more, especially those who have reached the age of 30, are concerned with the chronic and more likely life-disruptive facial skin disorder that is called Rosacea.

Many individuals, aged above 30 years old, begin to notice that they blush or flush more often. Surprisingly, however, the redness, which become more persistent and ruddier overtime, also tend to affect not only their cheeks, but their chin, nose, forehead, scalp, ears, neck and chest too. Worse, besides the redness, blood vessels, likewise, begin to become more visible.

This facial redness is the first sign of rosacea, which usually affects fair skinned individuals who easily flush or blush. And while women develop it more than men, it is in men that the symptoms of the disorder are diagnosed to be more severe. In some instances, even the eyes become affected, causing feelings of eye irritation and appearing bloodshot or watery.

Leaving rosacea untreated can lead to the development of pimples and bumps; it can also make the nose grow swollen and bumpy, a condition called rhinophyma. The cause of rosacea is unknown, thus no cure is known for it; it can be controlled, however, and its signs and symptoms, reversed or controlled.

One of the most effective ways of treating the facial skin disorder is through Intense Pulsed Light (IPL) photofacial treatment. Treatment of rosacea depends on the patient’s skin type and usually requires 3 – 5 sessions that are spaced 4 weeks apart from each other – this is for optimal redness reduction. While each session takes only minutes, the effect can last for months or years, depending on how well the patient complies with the use of recommended sunscreens.

Those who suspect that they may have the facial skin disorder are advised to see a dermatologist an aesthetic doctor for the appropriate treatment. According to a consensus arrived at by a committee of 17 medical experts from around the world, rosacea has primary and secondary symptoms. Its primary signs include flushing, persistent redness, bumps and pimples and visible blood vessels, while its secondary symptoms may include eye irritation, burning or stinging, dry appearance of facial skin, plaques or red patches, skin thickening, facial swelling, and redness on the scalp, ears, neck and/or chest.

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Medical Product Liability: Defective Pharmaceutical Products

All those who are engaged in the pharmaceutical industry are morally and legally obliged to make sure that every product they manufacture, whether drugs intended to treat serious health conditions or medical devices meant to enhance, support or replace damaged or missing biological structures, are effective and more so, totally safe. This is why every product that is introduced will have to undergo clinical tests first, to determine how it will actually affect patients, before the US Food and Drug Administration approves it for public use. All types of medicine and medical devices, anyway, are produced to control and treat bodily ailments or to help maintain people’s good health.

There have been many instances, though, wherein certain prescription drugs and medical devices have caused adverse effects or have put patients in greater risk of developing a new severe illness, rather than providing the cure that they seek (for their original health complaint). And worse, use of some pharmaceutical products have even been linked to the death of patients.

Concerning prescription drugs, specifically, it is absolutely necessary that doctors know everything about a patient’s total health condition, which includes history of illnesses, allergies, other medications taken, and so many others, before actually making any prescriptions. This is because individuals have different levels of bodily immunity, thus, a medicine that may work effectively to one may serve as poison to another – a really great risk that all doctors need to watch out for.

Reports of adverse effects are forwarded to the FDA which, after proving the veracity of such reports and their link to the drug specified, will advise the manufacturer to include in the drug’s prescription label the risk/s associated to its use. There are also times when, due to the severity of the harm caused by a drug, the FDA would issue a block box warning, the most serious warning given on drugs.

Adverse effects of drugs are often incredibly damaging. In some cases, drugs give patients suicidal thoughts, or in others cause unborn children to suffer physical mutations. Even though adverse effects may not be intended, instances of an individual suffering from them can make the drug’s manufacturer liable for whatever injury and damages the victim will suffer from. This is because whatever harm that may arise due to the use of defective pharmaceutical products is considered as personal injury, which is injury resulting from the negligent or careless act of another, the manufacturer will also be obliged to compensate that victim for whatever financial consequences the harm will lead to.

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