FDA Says Risk of Dangerous Avastin Breast Cancer Drug Side Effects Outweighs Benefits

FDA Says Risk of Dangerous Avastin Breast Cancer Drug Side Effects Outweighs Benefits | Pintas & Mullins Law Firm

Defective drug lawyers at Pintas & Mullins Law Firm are warning of the dangerous side effects that breast cancer patients may experience if they are using Avastin to control their tumors. The FDA recently revoked its provisional approval of the drug for the treatment of metastatic breast cancer amid concerns that it causes serious health complications such as hemorrhaging, high blood pressure and heart attacks.

Avastin was first approved in 2004 to treat colon cancer, and has since become one of the best selling cancer drugs in the world. It is also one of the most expensive drugs on the market, bringing in about $6 billion a year for the pharmaceutical company Roche. The FDA approved Avastin for advanced breast cancer as part of its accelerated approval program, which allows patients access to new drugs subject to further confirmation of their effectiveness.

An initial study of Avastin showed that it delayed the progression of breast cancer by about 5 months when combined with different chemotherapy drugs, even though patients did not live significantly longer and many of them suffered severe side effects. Subsequent studies reported in the New York Times showed that the drug delayed the disease by as little as one month and the significant risk of potentially fatal side effects did not justify its use.

Although Avastin is no longer approved to treat breast cancer patients, our concern is that it will still remain on the market. Physicians can still prescribe the drug to treat colon, kidney, lung, and brain cancers, along with any other uses they see fit. This includes prescribing the drug off-label for the treatment of breast cancer. Although most insurers have already stopped paying for Avastin for the treatment of advanced breast cancer, coverage will still be available through Medicare.

Our experienced drug injury lawyers are warning all cancer patients taking Avastin that they may be at risk for life-threatening complications. Some patients may develop holes in their colon, leading to internal bleeding and impaired wound healing. Heart failure and kidney damage are also possible side effects. When Avastin is combined with other chemotherapy drugs, the results may be even more dangerous. In 2006, several cancer patients suddenly died while being treated with a combination of Avastin and Xelox.

Breast cancer patients and all cancer patients taking the drug can file an Avastin lawsuit for their drug-related injuries. With the help of an Avastin attorney, the drug’s manufacturer may be held liable for failing to warn of the serious side effects associated with Avastin use. Failure to warn can also subject physicians to liability, because the law requires that medical professionals explain the risks of medications that they prescribe. 

Prescribing drugs for off-label use is also a source of increasing liability for physicians. Although physicians generally do not have a duty to disclose the FDA regulatory status of a drug to patients, courts have found that failure to provide information about the off-label nature of the drug can be used to show that the physician deviated from the standard of care if an injury occurs. Therefore, Avastin breast cancer patients may still be able to recover compensation by showing that prescribing the drug off-label deviated from the acceptable standard of practice, since it was not shown to be safe or effective for this use.

By filing an Avastin lawsuit, injured patients may be entitled to compensation for medical expenses, loss of income and pain and suffering. It is important to contact an Avastin lawyer as soon as possible, because the period of time to file an Avastin lawsuit is limited. Our defective drug lawyers can explain your legal rights and options, and help guide you through the litigation process.