Drug Defects: July 2009 Archives

July 23, 2009

Study Shows Asthma Drug, Xolair, May Increase Heart Failure Risk

The U.S. Food and Drug Administration (FDA) recently released an "Early Communication" concerning the asthma drug, Xolair.  According to the report, patients taking Xolair have a disproportionate increase in heart failure, arrhythmias, enlarged hearts, stroke, and other vascular conditions compared to patients not taking the drug.  Xolair, also known as Omalizumab, is an injected medication used to treat moderate to severe asthma that cannot be controlled by inhaled corticosteroids.

Xolair was approved by the FDA in 2003 and now accounts for $517 million in revenues for its manufacturer, Genentech.  Genentech merged with the international pharmaceutical behemoth, Roche, in March.  Genentech and Roche have both had recent setbacks with drugs such as Xolair and Accutane.  Accutane was recently pulled from the market and Xolair received a black box warning in 2007 for the potential risk of anaphylaxis.

Although the FDA advises patients to continue to take Xolair as prescribed and refrained from issuing prescribing changes, it continues to investigate the potential causal connection between the drug and the reported adverse health risks.  The final results of the study are anticipated to be available to the FDA in 2012.

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July 14, 2009

Acne Drug, Accutane, Pulled from Market

The drug company, Roche, has pulled its acne medication, Accutane, from U.S. markets citing economic reasons and stiff competition from generic competitors. The removal comes, however, amidst numerous jury verdicts against the drug company for failing to warn of the medication's dangerous side effects. In 2007, a Florida jury found against Roche in the amount of $7 million for failing to warn of potential health risks. The removal of Accutane adds U.S. markets to a list of eleven other countries that have also seen the potentially dangerous drug removed from circulation.

According to reports, nearly 13 million people have taken Accutane since its release in the early 1980s. There are currently 5000 personal injury suits involving Accutane stemming from Roche's failure to warn of potential inflammatory bowel disease. Other serious safety concerns surround Accutane including causing psychosis, depression, suicidal thoughts and actions, birth defects, miscarriage, and premature birth.  Cases involving the dangerous health risks of Accutane continue to be litigated across the United States.

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July 7, 2009

Potentially Dangerous Drug Darvocet Gets Black Box Warning

The U.S. Food and Drug Administration (FDA) announced today that it will require manufacturers of drugs containing propoxyphene, such as Darvocet and Darvon, to include boxed warnings on their products which emphasize the risk of death and injury from overdose associated with the drug. This action comes after a British study and other data linked propoxyphene and fatal overdoses. The FDA is also requiring that manufacturers provide information with the drug stressing the importance of taking the medication as directed.

According to reports, the FDA refused to order a phased withdrawal of the potentially fatal drug from the market, despite an advisory panel's decision in favor of removing the product from circulation. Rather, the FDA decided to require further safety studies of the product to determine the effects of propoxyphene at higher than recommended doses.

Critics of the drugs argue that propoxyphene, a member of the group of drugs known as opioids and used to treat mild to moderate pain, poses a greater risk of addiction and fatal overdose than warranted by its arguable benefits. An estimated 21 millions prescriptions for propoxyphene-containing drugs were written in 2007 and reports indicate that 503 deaths were associated with the drug Darvon including 20% from suicides.

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