Zofran Study Says its Safe for Pregnant Women—But Maybe Not

A two-year-old study made about Zofran (ondansetron) concluded that there was no evidence that the drug posed any risk of birth defects in children of women prescribed with it for severe nausea and vomiting of pregnancy (NVP) or morning sickness. However, an extension of the same study by another group of researchers concluded the opposite. So which is it?

The study Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes was published in the February 2013 issue of the New England Journal of Medicine. It made use of records from the Danish Birth Registry between 2004 and 2011, where each of the 1,970 women exposed to ondansetron were matched to 4 control cases. The researchers concluded that no adverse fetal outcomes were associated with ondansetron use.

This was welcome news for women that had already taken the drug in the first trimester of their pregnancy. However, the same study was presented to the International Society of Pharmacoepidemiology in Montreal six months later using a larger number of women over a longer period of time (1997 to 2010) from the same registry. The results of that study indicated that there was a two-fold risk of adverse fetal outcomes associated with ondansetron.

Which study should be believed? At this point, it is a toss up. Common sense dictates that pregnant women should avoid Zofran altogether until there is a definite conclusion either way. There are alternative medications to alleviate the symptoms of NVP that are safe for pregnant women. At any rate, the Food and Drug Administration (FDA) does not approve Zofran for NVP, so that should be an indication to stay away.

However, according to the website of Williams Kherkher, if this warning comes too late, you can still address the issue. If you were prescribed with Zofran while pregnant and your child has birth defects, contact a dangerous drug lawyer in your area immediately to discuss how to get compensation.

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Surprising Signs of Depression

Most everyone knows depression is usually indicated by extended sadness. However, each individual copes with their depression differently, making the illness hard to identify for some people. If you have experienced a behavioral change lately, here are signs it may be attributed to depression.

Drastic Increase in Exercise

If you have taken to exercising for several hours a day, or multiple times a day, when you didn’t before, this may indicate depression. Your body may be craving endorphins due to extended sadness. Clearly, exercising is a great habit—but a sudden, almost compulsive desire to hit the gym may be a warning flag.

Change in Eating Habits

Any major difference in eating habits may indicate depression. A depressed individual may pick at food when he or she usually has a healthy appetite—or, on the other hand, binge eat. Depression may even lead to eating disorders.

Thrill-seeking

Those who are fighting away depression often engage in thrill-seeking behavior, including an increase in sexual activity. Likewise, they may gamble or make drastic life choices, such as quitting a job or getting a tattoo.

Aggressiveness

Those entering depression may be more likely to start fights. Minor conflicts could be an excuse for them to yell and discharge feelings of anger and sadness.

Detachment/Lack of Emotion

Individuals may display a marked lack of interest. They may seem “flat”, or display less emotion. Depressed people may avoid hobbies and people they love, isolating themselves. They may not show any signs of sadness—or any other emotion.

Lack of Focus

If you or a loved one are constantly daydreaming—to the point where daily activities seem nearly impossible due to an inability to focus—this may indicate depression.

These hints are not a clinical diagnosis. If you or someone you know is experiencing several of these signs, it may be wise to seek psychiatric assistance. Only a psychiatrist or a doctor can prescribe medication, and serotonin re-uptake inhibitors (SSRIs) such as Prozac have been known to assist depressed people with their disease. However, there are instances where a person should not take SSRIs due to certain complications that may arise. For example, women who take Prozac during pregnancy may risk birth defects in their developing child. Additionally, SSRIs are not meant to be a cure on their own; they work best when coupled with therapy.

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Personal Injury with Dangerous Drugs

Modern Western medicine relies heavily on pharmaceutical preparations in treatment or health management protocols. Many drugs have been developed over the years that have undoubted benefits, although they are unfortunately too often offset by side effects. Historically, these side effects are revealed on a trial-and-error basis, and dangerous drugs such as cocaine have been withdrawn from the market when the health risks outweighed the benefits.

Regulations are currently in place to minimize the risks posed on the general public by these drugs. Before a new drug or formulation is approved for use, agencies such as the Food and Drug Administration require that drug companies comply with procedures designed to determine the safety and efficacy of the products. This includes clinical trials that should reveal what side effects it may have. In general, drug companies observe their duty of care and follow these procedures. Sometimes, though, they breach this duty out of greed or inadvertence.

Take the case of Granuflo. First introduced in 2003, it is a dry acid formulation designed to improve the acid neutralizing capacity of bicarbonates during dialysis. It was marketed to facilities that cater to patients with reduced kidney function, and a dialysis machine is used to clean the blood of toxins in lieu of the kidney. An overdosage of Granuflo could lead to potentially fatal cardiac problems, including but not limited to metabolic alkalosis. According to the website of Williams Kherkher, the real problem that led to lawsuits filed against manufacturer Fresenius Medical Care (FMC) is that the company failed to inform non-FMC dialysis centers about these dangers even as they circulated a memo to FMC centers about it.

When personal injury results from the failure of drug companies to warn about dangerous side effects or to take the necessary steps to ensure the safety of their patients, this can be construed as negligence. Consult with a product liability lawyer experienced in civil litigation cases involving dangerous drugs to see if you have an actionable case.

If you have been hurt because of a dangerous drug, make sure to contact a personal injury lawyer as quickly as possible. An attorney will be able to help you through your case and make sure that you are justly compensated.

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