Accutane

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The Importance of Reporting Drug Side Effects:

It is important to report any adverse drug event whether the information comes from a patient or healthcare provider. Reports should be made to the FDA and the manufacturer. This can make a difference in the overall safety of a drug after it has been approved by the FDA for use in the population. Reports of drug side effects are the fastest way of getting information out and identifying new and serious medical complications unforeseen in clinical trials. Once the FDA has been informed, the agency can evaluate and act on the problem to update the medical community, manufacturer, and patients.

Believe it or not, healthcare providers in the United States are not required to report drug side effects. In fact, physicians rarely report side effects.

Drug side effect reports can draw attention to important safety issues. If the FDA has this information early on, they can make changes on how a drug is used and advertised, and perhaps determine quickly whether the drug should be recalled.

The question of drug-related birth defects is particularly ...
... important and difficult to address. Doctors must be observant and report anything suspicious. Major birth defects occur in the general population at an approximate rate of 3-5%. The FDA is dependent on alert doctors who identify potential defects and report this information quickly. In the case of isotretinoin (Accutane effects), reports early in its marketing allowed the FDA to enact the iPLEDGE program to prevent Accutane from being used in pregnant women. Unfortunately, this was not the case with other Accutane effects such as Inflammatory Bowel Disease, suicide, depression, heart attack, and seizures.

FDA Laws:

According to the FDA, Manufacturers are required by law to report all side effects associated with their drug to the FDA regardless of whether or not they consider them causally related. If the events are new (i.e. not in the product label) and are serious (defined as resulting in death, hospitalization, prolongation of hospitalization or illness, or birth defects) they must be reported within 15 days from the time the company becomes aware of the event. This also applies to literature reports ---- when the manufacturer identifies side effects through routine literature searches, they must report them in the same manner. Reports that are neither new nor serious are provided to the FDA in periodic reports (every 6 months in the first 3 years after marketing, then yearly).

The FDA requires that a drug may be approved with at least 2 randomized controlled clinical trials that show the drug is effective. The safety of an approved drug is determined by pre-clinical studies in the lab and on animals, particularly for cancer and birth defect risk, and human clinical trials up to the time of approval.

There are certain limits to clinical trials, including the fact that patients are healthier than individuals who will be taking the drug, the fact that the drug is not tested in special populations (i.e. pregnant women, children, elderly), and the fact that serious side effects occur infrequently. For example, liver failure is found in 1 in 5,000 to 20,000 people, but when the drug is used by millions, this rare occurrence translates to a sizable number of cases.

Among other methods, researchers use the rule of 3 to determine clinical trial sample size to detect side effects. For example, if a side effect has a rate of 1/5000 then it is necessary to evaluate 15,000 patients to have a 95% chance of detecting 1 case. Therefore, many thousands more patients need to be studied to identify cases for study.

As there will be cases of side effects in special populations not demonstrated in clinical trials that will be observed after marketing the drug, healthcare providers are often placed as watchdogs over a new drug's response in the population. It is imperative that both clinicians and patients report any new event promptly.

If you have experienced Accutane effects, you may be entitled to financial compensation. You may want to see if you qualify for an Accutane lawsuit.

Author Bio.

Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research. Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising. To learn more about Accutane effects or Accutane lawsuit please visit www.ConsumerInjuryLawyers.com