Drug Defects: May 2009 Archives

May 8, 2009

Potential Medical Malpractice for Prescriping Drugs That Increase Suicidal Thoughts

The U.S. Food and Drug Administration (FDA) has warned that antiepileptic (or anti-seizure) drugs such as Topamax, Lamictal, and Lyrica can increase the risk of suicidal thoughts and behaviors.  Because these drugs are so widely used throughout the United States, the warnings pose an intriguing question as to who is responsible to warn and monitor the patients that take these potentially deadly medications and when a failure to either warn or monitor becomes medical malpractice.

Generally, when speaking of prescriptions drugs, the manufacturer's duty to warn of potential risks and side-effects is limited to adequately advising the prescribing doctor of any risk that may result from the patient's use of the drug.  This is because the prescribing doctor acts as a "learned intermediary" and considers both his understanding of the patient's condition and the potential risks of a drug when making a decision to either prescribe the drug or not.  However, the knowledge the doctor has available to him is not static and changes when new tests and studies become available as seen in the case of antiepileptic medications.  Failing to inform patients already prescribed a certain medication of newly discovered risks associated with that drug may result in medical malpractice.

Doctors have a duty to disclose the risks associated with medications or courses of treatment.  This duty can include explaining to the patient what is at stake when taking the medication, any alternatives, what goals the doctor is attempting to achieve, and the risk of the treatment and the risk of no treatment at all.  Florida law requires doctors to explain the serious risks and the possibility of serious harm taking the drug entails so that an intelligent choice can be made by the patient by balancing the possible risks and the possible benefits.  Therefore, when new risks are made known to the doctor by the manufacturer or other source, the argument can be made that it is medical malpractice not to inform the patient of the new risk so that they may make an informed and intelligent decision based on the new information.

Doctors also have a duty to monitor their patients during their course of treatment.  Obviously, a failure to monitor a patient prescribed a drug that increases suicidal thoughts and behaviors could be deemed malpractice.  It is important for the prescribing medical professional to closely monitor a patient taking antiepileptic medications to ensure the risks of suicidal behavior do not begin to outweigh the benefits of the drug.  Failure to properly monitor a patient could have devastating effects including death or serious injury.

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May 6, 2009

Dangerous Diet Pill Hydroxycut Causes Injury And Death

Florida residents should immediately stop using the potentially defective dietary supplement, Hydroxycut, according to the U.S. Food and Drug Administration (FDA) which recently warned of serious injuries associated with the product across the U.S.  The FDA has tracked 23 cases of people reporting health complications after taking Hydroxycut including jaundice, liver damage, seizures, cardiovascular disorders, and rhabdomyolysis.  One death linked to the dietary supplement has also been reported to the FDA.

Dietary supplements are not regulated by the FDA until after they have reached the market.  Unlike prescription drug manufacturers, dietary supplement makers are self-regulated and responsible for ensuring their products are safe and effective and contain the proper warnings prior to coming on the market.  Once on the market, the manufacturers are responsible for reporting known health hazards caused by their product, and the FDA takes action against products found to be harmful or adulterated.  Hydroxycut is the latest in a long line of dietary supplements tracked by the FDA found to either cause serious health issues or contain undeclared, active pharmaceutical ingredients.

If you have the associated symptoms or develop new symptoms after taking Hydroxycut, you should see your doctor as soon as possible.

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