Xolair Drug Safety Risk Alert From the FDA

FREECASE EVALUATION

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, Xolair Drug Safety Risk Alert From the FDA

Xolair Drug Safety Risk Alert

, Xolair Drug Safety Risk Alert From the FDA

The U.S. Food and Drug Administration (FDA) has reported potential risks associated with the drug Xolair (omalizumab) after a five year study submitted by the drug’s manufacturer, Genentech, a unit of Roche Holding AG, and 25 clinical trials that compared Xolair to a placebo.

Xolair was originally approved in 2003 as an injectable asthma medicine for patients (12 years and older) who suffer from moderate/severe recurrent allergic asthma and whose condition could not be controlled by inhaled steroids. The drug is used in asthma patients who have elevated levels of a substance called IgE in their blood and has also been approved to treat a form of chronic hives in both adults and children. It is marketed jointly by Roche and Novartis AG.

The study found several significant issues with patients who were treated with the asthma drug Xolair (omalizumab) compared to patients who were not treated with Xolair. They included:

  • a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear
  • slight increase of potential problems involving the heart and blood vessels supplying the brain
  • a greater risk of pulmonary hypertension, or high blood pressure in the arteries of the lungs
  • There was no significant difference in cancer rates between patients who use Xolair and those who don’t. However, since the study was only 5 years, the FDA determined they cannot rule out a potential risk of cancer with the use of Xolair. This warning was added to the Warnings and Precautions section of the drug label.

As a result, FDA has added the above information to the drug label. They also suggest patients taking Xolair should continue with the medication as prescribed by their doctor and talk with their health care professionals about any questions or concerns.

Healthcare professionals and patients are asked to report any adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

 

The FDA concluded that although the data suggests a serious safety signal, weaknesses in how the safety study was designed and carried out mean it is “unable to definitively confirm or determine the exact increased level of these risks with Xolair.”

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