Articles Posted in Product Liability

I remember kids in elementary school in the ’70s with asthma. It seemed rare back then. Not anymore. Statistics seem to bear this out. The prevalence of asthma is increasing worldwide and in particular in the United States.

The one thing you have to keep in mind in this article is the conventional wisdom is that there is no connection between asthma medication and birth defects or other injuries to the fetus.  The use of albuterol and other asthma medications are often necessary to keep the fetus healthy. So keep a pin in that as you read on.  Also remember the best thing you can always do is talk to your doctor about the risks.

Pulmicort and Pregnancy

Asthma has risks for all who suffer from it, but people are paying a lot more attention to the issue of pregnancy and asthma and whether asthma medications can cause injury to the expectant mother or the unborn child. Specifically, people are questioning whether asthma drugs like budesonide (Pulmicort) that contained glucocorticoids increase the infant’s risk of developing metabolic and endocrine disorders.

Does this mean you should not ever use Pulmicort while pregnant? Of course not.  But you need to understand all the risks and talk to your doctor about them so you get on the path that causes the least risk.

Many Women Use Asthma Medication During Pregnancy

Between 4 and 12% of pregnant women have asthma and 3% use asthma medications during pregnancy. Women with asthma are at an increased risk of complications during pregnancy due to inadequacy in controlling asthma and/or some medications used to manage asthma.

A Fetus Needs Oxygen

Certainly, doctors are in a Catch 22. Poorly controlled asthma can result in an inadequate supply of oxygen to the fetus. Asthma during pregnancy can lead to preterm labor, cesarean section, and hypertensive disorders, including preeclampsia and placental previa. Severe asthma can result in maternal mortality, fetal mortality, or both.

The Key Is Understanding the Risk

Therefore, management of asthma during pregnancy may be necessary to improve the mothers’ asthma, even if risks are present with the use of such medications. It is always important to weigh the potential risks to the fetus against the benefit of the mother. To do this accurately, drug companies have to tell us what the risks of asthma and pregnancy are. What are they? We don’t know what the drug companies know, but what we do know is mixed.

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In the United States, the FDA is responsible for the legitimacy of the claims on product labels. The FTC is responsible for regulation of product advertising. Not many people understand this and the two do step on each other’s toes at times. What the FTC has advertised, approval must be obtained from the FDA in order to make treatment or prevention claims.

People that make weight loss drugs are not scared of the FDA and FTC. The FDA and FTC have issued 7 joint warning letters to companies marketing over the counter (OTC) drugs advertised as homeopathic for weight loss. Warning letters have been issued as the claims are unsubstantiated (thus fraudulent), unapproved and in violation of federal regulations.

The weight loss product at issue contains human chorionic gonadotropin (HCG), a hormone found in the urine of pregnant women, produced by the human placenta. This alone should scare you off. HCG is currently only approved in the US as an injectable drug for the treatment of certain cases of female infertility and hormone therapy in men. The products subject of the current advisory are available as oral drops, sprays and pellets.

Diagnosis of malignant pleural mesothelioma is difficult and can often be mistaken for pneumonia, leading to a delay in treatment. But there is a new hope. Diagnosing mesothelioma with a simple breath test may be on the horizon.

A study recently published in September 2011 (e-pub ahead of print), has presented a novel test which analyzes exhaled breath using an electronic nose to detect malignant pleural mesothelioma. The concept for this analyzer was based on previous research that demonstrated electronic devices that could analyze exhaled breath and distinguish constituents in the breath which were characteristic in patients with lung cancer, due to characteristic “breath prints”. The recently reported study in malignant pleural mesothelioma patients demonstrated that the breath in patients exposed to asbestos who had malignant pleural mesothelioma, could be distinguished from the breath of patients exposed to asbestos who did not have malignant pleural mesothelioma, and from the breath of control patients who were not exposed to asbestos, with a sensitivity of 92.3% and specificity of 85.7%. Not a perfect test. But a great start.

These results suggest that such an analyzer may be beneficial in the diagnosis of malignant pleural mesothelioma or may be used as a screening tool to determine patient groups that may require further diagnostic testing. This preliminary research is very encouraging. Follow up validation tests will be the next steps that will need to be conducted prior to integrating into current diagnostic practices for malignant pleural mesothelioma.

Plavix (clopidogrel) is a prescription anti-platelet medication used to prevent stroke and heart attack in patients with cardiovascular disease. Plavix works by making blood platelets less likely to form clots.

It is generally taken in tablet form, once per day by mouth. Plavix is one of the best selling drugs worldwide, with over $8 billion dollars in annual sales.

As with many medications, Plavix may cause serious side effects, including:

Common Side Effects of Plavix

1. Bleeding: This is the most common side effect and can range from minor bruising to more severe bleeding.
2. Bruising: Increased tendency to bruise due to reduced blood clotting ability.
3. Nosebleeds: More frequent or prolonged nosebleeds.
4. Gastrointestinal Issues: Including stomach pain, diarrhea, indigestion, or heartburn.
5. Headaches: Mild to moderate headaches.
6. Dizziness: Feelings of lightheadedness or vertigo.
7. Itching or Rash: Skin reactions such as itching or rashes.

Serious Side Effects of Plavix

1. Severe Bleeding: Including gastrointestinal bleeding, brain hemorrhage, or bleeding within the eyes.
2. Thrombotic Thrombocytopenic Purpura (TTP): A rare blood condition involving blood clots forming throughout the body.
3. Hemorrhagic Stroke: Bleeding in the brain, especially in patients who have had a recent brain injury or surgery.
4. Ulcers or Holes in the Stomach or Intestines: Manifesting as severe stomach pain, bloody stools, or vomit that looks like coffee grounds.
5. Allergic Reactions: Symptoms may include rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
6. Liver Problems: Symptoms such as yellowing of the skin or eyes, dark urine, or persistent nausea/vomiting.
7. Low White Blood Cell Count: Leading to increased susceptibility to infections.

Drugs come with side effects. We all get that. So that is not the question. Instead, the question is whether the maker of Plavix knew that people who are unable to metabolize Plavix adequately were at greater risk for a heart attack. Since Plavix will not work until it is metabolized in the body, these individuals are at a greater risk for heart attack and stroke.

This increased risk is so great that in March of 2010, the FDA added what is known as a “Black Box Warning” to Plavix to alert both patients and physicians that the drug can be less effective in those patients who are unable to metabolize it into the active form. It is estimated that as many as 14% of the U.S. population are poor metabolizers of Plavix.

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The Food and Drug Administration (FDA) is urging Healthcare professionals to remain vigilant about reporting cases of malignancy in patients treated with TNF blockers to MedWatch. This comes after the FDA has continued to receive reports of a rare cancer of white blood cells, known as Hepatosplenic T-Cell Lymphoma or HSTCL.

The FDA updates on Tumor Necrosis Factor (TNF) blockers

HSTCL is an aggressive cancer and is usually fatal. The majority of the reported cases were in patients that are being treated for Crohn’s disease or ulcerative colitis, but also include a patient that is being treated for psoriasis and two patients that are being treated for rheumatoid arthritis. The FDA is now updating the number of reported cases of HSTCL. Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

Researchers have uncovered a link between breast cancer treatment and type 2 diabetes. According to a study conducted by The University of Toronto, it has been discovered that therapy with the drug Tamoxifen has been linked to a significant increase in the development of diabetes in older survivors of breast cancer.

Tamoxifen, an oral medication used in women with breast cancer, is one of the most widely prescribed drugs to prevent a recurrence in women who have been treated for the condition. Tamoxifen disrupts the female body’s production of estrogen, which promotes breast cancer in women. Research now suggests that the drug may contribute to an increased risk of developing type 2 diabetes. Researchers state that no one taking Tamoxifen should discontinue their use of the medication, but they and their doctors should know the association.

For the study, the researchers examined the medical records of 14,360 women over the age of 65 who had been diagnosed with early-stage breast cancer, and had survived. The results, which were published in the journal “Cancer”, showed that Tamoxifen patients are 25 percent more likely to develop type 2 diabetes.

Accutane lawsuits arise out of the allegation that Accutane, an acne medication that has been available for almost 30 years, causes serious bowel problems, Crohn’s Disease, and Stevens-Johnson Syndrome. Our lawyers are reviewing these claims. For a free consultation, call 800-553-8082 or get more information online.

Accutane lawsuits have been going on for some time now. But interest in these lawsuits rose dramatically after a $25 million verdict against the manufacturer of Accutane earlier this year. The lawsuit played out like a novel. The Plaintiff got a $2.62 million verdict only to have an appellate court take away the verdict. A new jury heard the case and tacked on an additional $23 million. That is a strong message.

There are over 1,000 Accutane lawsuits now pending. If you think you may have a claim, find out if we can help you. Get a free online no obligation consultation.

The Journal of the American Medical Association reports that Spiriva HandiHaler patients may face an increased risk of heart attacks or strokes and other cardiac problems.

Concerns with Spiriva

The Spiriva HandiHaler (generic: tiotropium bromide inhalation powder) is an inhaler for long-term treatment of bronchospasm linked with chronic obstructive pulmonary disease (COPD). This disease is commonly described as emphysema and chronic bronchitis.