The Food and Drug Administration has announced that propylthiouracil (PTU), a drug used to fight Graves' disease, has been linked to over 30 cases of liver damage in both adults and children. In the warning issued June 3, the FDA reported adverse affects that killed 12 adults and caused five more to need liver transplants. Ten cases involved children, in which six required transplants and one child died.

Graves' disease is a disorder that causes hyperthyroidism, caused by the body's immune system attacking the thyroid gland. It causes hypertension, irritability, weakness, fatigue, problems sleeping, and rapid heartbeat.

Symptoms of liver damage include jaundice, stomach pain, dark colored urine, light colored stool, nausea and vomiting, and rapid heartbeat.

PTU is thought of as a "second line" treatment in combating Graves' disease, and is usually given to the patient if they are allergic to methimazole. Women with Graves' disease who are in their first trimester of pregnancy are also given methimazole. The drug has been prescribed since 1947 to thousands of people.

The FDA has asked health care professionals to monitor their patients already on propylthiouracil. While they have stated that it may still be better for women to continue taking the medication if they are in their first trimester, contact your physician to discuss your options.

If you or a loved one suspect you may have developed liver damage as a result of taking propylthiouracil for Graves' disease, please contact the defective drug attorneys at Stipe, Harper, Laizure, Uselton, Belote, Maxcey & Thetford for an initial consultation.

The Food and Drug Administration has notified the public that 23 cases of liver damage have been tied to the popular dietary supplement called Hydroxycut. This listing includes several cases of serious liver injury, as well as one reported death. Iovate Health Sciences, Inc. has voluntarily recalled the affected Hydroxycut products, and the FDA has asked consumers to cease taking this defective product. Although Hydroxycut has been withdrawn, the liver damage caused by the product is progressive.

If you or someone you know has been taking Hydroxycut, here are some symptoms to be aware of:

• Nausea or vomiting
• Itching
• Weakness or pain in muscles
• Jaundice
• Dark colored urine
• Light-colored stool
• Stomach pain
• Fatigue
• Shortness of breath

If you have any of these symptoms and have been taking Hydroxycut, you may have suffered liver damage. Stop taking this product immediately and see your physician as soon as possible. If you have stopped taking Hydroxycut, but have any of these symptoms, you may still have liver damage.

If you believe you or a loved one may have damaged your liver as the result of taking Hydroxycut, you may be entitled to compensation. Please contact the experienced product liability lawyers at Stipe, Harper, Laizure, Uselton, Belote, Maxcey & Thetford for an initial consultation.

Before being given approval by the Food and Drug Administration (FDA), a prescription medication must be proven to be "safe and effective for its intended use." However, the current rules of the Center for Drug Evaluation and Research (CDER) allow the prospective drug manufacturer, known as the "sponsor," to design and perform the research. This often includes designing the experiments, picking the doctors or scientists to perform the experiments, compiling the experimental data, and reporting that data to the CDER. Because the experiments are designed with the hopes of approval and scientists are often chosen based on their relationship to the sponsor (often including an investment in the drug they are evaluating), drug trials tend to promote the possibilities of a drug while downplaying potential side effects.

As a result, many drugs are approved without a full appreciation of many potentially dangerous characteristics and can end up being products liability cases. Dangerous effects include:

• Serious side effects
• Long-term exposure effects
• Dangerous drug interactions
• Quality control issues

Once a defective drug has made it to the market, it is often accompanied by a big marketing push, similar to any other product, with doctors being invited to promotional seminars on using the new drug and given free samples to distribute. This generosity ensures that a new drug is often widely distributed, sometimes in situations where it is of dubious value. Now that it is being taken by thousands or even millions of people, the real trial begins.

Researchers have to compile evidence proving the danger posed by the drug, but once this connection is proven, the FDA may not issue an immediate recall. Sometimes, as in the case of Trasylol, many people can die between the time that researchers report a dangerous side effect, and when the FDA and the manufacturer decide to issue a recall.

There are many reasons why a defective drug may enter the marketplace, including the simple fact that the human body is an incredibly complex machine and it is impossible to predict all the effects of a drug. But product liability/defective drug lawsuits play an important role in refining the approval process by making it unprofitable for drug manufacturers to market drugs they know to be dangerous.

If you live in Oklahoma City or anywhere in Oklahoma and have been harmed by a dangerous product, please contact product liability attorneys Stipe & Belote, LLP today to schedule a confidential consultation.

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