Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

As the Justice Department charged Forest Laboratories Inc. in February with illegal marketing of its antidepressants Celexa and Lexapro, the U.S. Food and Drug Administration (FDA) approved the use of Lexapro for use in children.

Forest Laboratories Inc. marketed the drugs for use in children and adolescents even though it had no FDA approval for such use. The civil complaint filed against the company alleges that:

• Executives at Forest promoted favorable results from one clinical trial to purport that the drugs were effective in children. The trial, conveniently enough, was financed by the company. Another study, that did not result in such favorable findings, was concealed and the company failed to share the results of that study.
• The company awarded pediatricians who prescribed the drugs. There were ski vacations, gift certificates, fishing trips, and spa visits dangled before doctors to coax them into prescribing Celexa and Lexapro.
• Forest conducted trials that were simply marketing campaigns in the guise of studies. Doctors are not prohibited from prescribing drugs for unapproved uses; drug makers, however, are not allowed to promote off label or unapproved uses of drugs. In recent weeks, Eli Lilly settled an off label use promotion suit and Medtronic had a medical injury lawsuit filed against them for off label promotion of its Infuse bone growth product.

The allegations that Forest Laboratories Inc. concealed studies showing unfavorable results for Lexapro and Celexa seem to have received no attention by the FDA. On March 20th, the agency approved the use of Lexapro for use in adolescents. Lexapro is only the second antidepressant approved for use in younger patients.

Medical Injury Attorneys

Often, pharmaceutical companies indulge in unethical and illegal marketing of products that have not been approved for certain uses. Forest Laboratories' illegal marketing of Lexapro and Celexa for use in younger patients even before they were approved for such use, could have placed children and adolescents at risk of antidepressant abuse. Antidepressant medications, when not used as they are prescribed, can cause suicidal fantasies or worsen symptoms of depression. Unfortunately, we often see pharmaceutical companies ignoring health risks posed by unapproved uses of drugs to increase profits without thought of the risks of medical injuries.

Patients injured by unapproved use of a drug can consult a medical injury lawyer to file a lawsuit against the company, if it was engaged in promoting such off label use.

If you or a loved one has been injured by the use of Celexa or Lexapro, contact a medical injury lawyer at Arnold & Itkin LLP to learn about your options for compensation.

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As the Bush administration prepared to vacate office, the Food and Drug Administration (FDA) issued new guidelines that ease restrictions on promotion of off-label drug use by pharmaceutical companies. The rule has been severely criticized because it may lead to more dangers when pharmaceutical drugs are used in ways not approved by the FDA.

It is illegal for pharmaceutical companies to promote off-label use of their drugs, although physicians are allowed to prescribe drugs for purposes not approved by the FDA. Doctors are allowed and often do rely on published medical research to prescribe drugs for unapproved uses to their patients. In its new rule, the FDA allows pharmaceutical companies to cite medical journal research supporting off-label uses of a drug. The biggest problem with relying on medical journal articles is that such research does not go through a strict screening process. It is hardly meant to be used as a substitute for the rigorous approval procedures conducted by the FDA.  Plus, there is also the risk that pharmaceutical companies may pay medical researchers and scientists for articles that recommend promotion of the drug for off-label use, which clearly would not be genuine, in-depth research articles.

The new guideline has been criticized from both within and outside the Bush administration. The Department of Veterans Affairs, patient advocacy groups, state prosecutors and medical injury lawyers around the country stand adamant that the new guidelines will weaken an already unstable FDA and expose patients to the omnipresent dangers of off-label drug use.

Off-label drug use continues to be a major danger to patients at risk of side effects from such drugs. Recently, Eli Lilly and Company agreed to a mammoth settlement over civil and criminal lawsuits arising from off-label drug use promotion. Also, Medtronic currently faces a lawsuit arising from the same unethical practices related to its Infuse Bone Graft. The threat of massive civil and criminal liability is the only thing preventing mass off-label promotion by drug manufacturers.  In the absence of rules completely prohibiting such promotion, drug manufacturers will have the freedom to place patients at risk in order to multiply their profits.

Promotion of off-label drug use by pharmaceutical companies can expose patients to unknown side effects simply because off-label uses are not researched as extensively as approved uses and, therefore, have little research to provide help in the case of adverse effects. In such cases, patients who have been injured can file a medical injury lawsuit against the company with the help of a medical injury lawyer.

If you have been injured by the use of a defective pharmaceutical drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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