FDA INVESTIGATING WEIGHT-LOSS DRUG: COULD LAWSUITS FOLLOW?

The U.S. Food and Drug Administration (FDA) announced on August 24 that it is investigating reports of liver damage among patients taking orlistat, a popular weight loss drug marketed as prescription Xenical and the over-the-counter Alli.

Though orlistat in its prescription form appeared in 1999, Alli became the first non-prescription drug approved in America to treat obesity in 2007. The difference between the two versions is dosage – 120 milligrams versus 60 milligrams. Though diet drugs are becoming increasingly popular, some doctors have noted that the benefits of this particular one may be rather modest – a weight loss of perhaps ten pounds in conjunction with diet and exercise.

The FDA has so far received 32 reports of adverse liver effects in patients taking the drug in the past ten years, including instances of jaundice, weakness, and stomach pain. There is not yet any definite link between orlistat and these symptoms, and the FDA has not recommended that patients taking either Xenical or Alli should discontinue use – but did note that anyone experiencing these symptoms should consult a doctor.

Diet drugs and supplements have proven to be a persistent problem for the FDA, and a persistent presence in the legal community. Earlier this summer, the recall of Hydroxycut was also prompted by concerns about liver damage, and of course, lawsuits over fen-phen are still ongoing. There have already been tens of thousands of cases concerning the now-banned diet drug, including a one billion dollar award for one plaintiff. Will Xenical and Alli prompt similar lawsuits? Only time will tell.

MICHAEL JACKSON’S DEATH RULED A HOMICIDE

Permanent link

After two months of speculation about the circumstances surrounding Michael Jackson’s death, the Los Angeles county coroner has ruled it a homicide. An anonymous law enforcement official told the Associated Press that the ruling was based on the discovery of a combination of anesthetic propofol and sedatives in the pop star’s system.

The finding could result in criminal charges for Jackson’s doctor, Conrad Murray, who had been caring for Jackson in a Los Angeles mansion at the time of his death.

An affadavit used to outline probable cause for search warrants for the offices of doctors who may have treated Jackson detailed a timeline of drugs administered to him before his death. It listed at least five doctors and a nurse practitioner, all of whom had recently treated him.

Some are speculating that Dr. Murray could be charged with involuntary manslaughter. This crime carries a maximum sentence of four years under California law. The statute defines “manslaughter” as “the involuntary killing of a human being without malice.” To be “involuntary,” the act must occur either during a lawful act or during an unlawful act that does not amount to a felony. Typically it would involve negligence of some sort, “without due caution or circumspection.”

However, it is unclear at this point whether Jackson’s death can be attributed to a single night or the single doctor’s actions, or whether the potential negligence of multiple physicians over a period of time could be to blame.

Reglan Overview

Over 2 million people in the United States each year take Reglan, a drug commonly used to treat gastrointestinal disorders. However, the Food and Drug Administration (FDA) has warned that for patients using Reglan, tardive dyskinesia (TD) could be a potential danger. This debilitating movement disorder has prompted a number of Reglan lawsuits since the FDA advisory in March 2009.

The medicine is composed of metoclopramide, a dopamine receptor antagonist, as well as an antiemetic. It has been used to treat a variety of gastrointestinal disorders like heartburn and diabetic gastric stasis since its introduction in 1982. It has also been prescribed to those suffering from gastroparesis, or partial paralysis of the stomach. In this disorder, food is slowed significantly in the digestive track, causing a variety of side effects such as heartburn, upper abdomen pain, nausea, vomiting, and weight loss.

However, despite the FDA’s warning, many people are still unaware of the potential metoclopramide side effects, since various versions of the prescription are still available. The agency has noted that occurrence of TD is “directly related to the length of time a patient is taking metoclopramide and the number of doses taken." The director of the Center for Drug Evaluation and Research, Janet Woodcock, advised that "chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.” Older women appear to be at increased risk, as well as those with these pre-existing conditions:

• Diabetes
• Psychosis
• Substance abuse
• Organic brain atrophy/dysfunction
• Genetic predisposition

Reglan-induced tardive dyskinesia can be a debilitating disease with no known cure. It presents with a variety of symptoms, but most sufferers report:

• Repetitive, involuntary movements of the arms and legs
• Lip smacking and other mouth and lip movements
• Rapid blinking
• Diminished movement of the fingers

These movement problems primarily affect the mouth and face, including frequent and uncontrollable biting motions with the jaw and puffing up of the cheeks. While involuntary motion typically begins as mild, it can become more severe over time. These difficult symptoms often cause mental, as well as physical stress and strain. TD most commonly occurs when the medication has been taken for longer than 12 weeks.

Particularly troubling is the fact that the drug is sometimes prescribed to infants who suffer from gastroesophageal reflux. This condition can be very painful, and prevent them from getting the nutrition that they need to grow. However, the FDA has not approved metoclopramide for use in children, and unfortunately, there has already been reported cases of infant tardive dyskinesia. Because the signs are already difficult to recognize, it often remains undiagnosed in babies.

Additionally, approximately .2% of people who take neuroleptics contract neuroleptic malignant syndrome. This disease typically progresses from muscular rigidity to high fever and instability of the autonomic nervous system, including irregular blood pressure, cognitive problems, marked agitation and restlessness, delirium, and coma. These signs may be mistaken for mental illness and go undiagnosed – but without treatment, the disease can be fatal.

The FDA now requires that the label and Reglan information include a “black box” warning. This type of alert is named for the black border that surrounds the notice, and indicates that medical studies have shown that the drug carries a significant risk of serious or life-threatening adverse effects. This is the strongest warning that the agency can require.

It should be noted that some Reglan side effects are minor and generally no cause for concern. These include decreased energy, diarrhea, dizziness, drowsiness, headache, nausea, restlessness, fatigue, and trouble sleeping. However, the side effects of Reglan can also be more severe, and anyone experiencing these symptoms should seek immediate medical attention. These include severe allergic reactions, difficulty breathing or skin irritation, confusion, abnormal thinking, unusual weight gain, sudden and increased sweating, shortness of breath, hallucinations, loss of bladder control, decreased sexual ability, changes in heart beat or heart rhythms, seizures, mental and mood changes such as increased depression or anxiety, and suicidal thoughts or actions.

TD can also been known to occur in conjunction with a variety of other antipsychotic drugs and neuroleptics such as Thorazine (Chlorpromazine), Clozaril (Clozapine), Haldol (Haloperidol), Seroquel (Quetiapine), Loxitane / Loxapac (Loxapine), Mellaril (Thioridazine), Navane (Thiothixine), Prolixin / Modecate (Fluphenazine), Piportil (Pipotiazine), Trilafon (Perphenazine), Orap (Pimozide), Stelazine (Trifluoperazine), Risperdal (Risperidone), Serentil (Mesoridazine), and Zyprexa (Olanzapine). There are also related non-neuroleptics, including Prozac (Fluoxetine), Zoloft (Sertraline), Nardil (Phenelzine), Elavil (Amitriptyline), Asendin (Amoxapine), Sinequan (Doxepine), and Tofranil (Imipramine).

Since the March 2009 Reglan warning, many of those who have been negatively impacted by this drug have sought legal assistance. Finding a lawyer with experience is essential, and a directory like LegalTube can help connect you to a Reglan law firm that will be able to assess whether your case fits the profile of metoclopramide lawsuits. If you are looking for information about Reglan and tardive dyskinesia, browsing these articles will help you learn more.