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Herceptin Heart Side Effects & Birth Defects

Research shows the anticancer drug trastuzumab—sold under the brand name Herceptin—causes serious heart-related problems and birth defects. The Rottenstein Law Group compassionately advocates for those who have suffered side effects as a result of having taken dangerous drugs. If you’ve taken Herceptin and believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Herceptin recalls and Herceptin class action lawsuits. We might be the Herceptin law firm you are looking for.

What Is Herceptin and What Is Prescribed For?

Herceptin is the brand name for the drug trastuzumab. Made and sold by Genentech, a subsidiary of the Swiss pharmaceutical giant F. Hoffman-La Roche, this prescription medication received Food and Drug Administration (FDA) approval for treating adjuvant breast cancer, metastatic breast cancer, and metastatic gastric cancer. Its first approval occurred in 1998, and Genentech sells it as an intravenous solution dosed at 21 mg/mL.

An antibody is an immune agent that attacks foreign substances in the body, such as viruses, bacteria, protists, fungi, and other pathogens. Researchers create a monoclonal antibody by duplicating immune cells from a single parent cell and then collecting the antibodies they create. Herceptin disrupts the activities of a protein in the cell membrane called “HER2 receptors,” which control cell survival, differentiation, and growth. The HER2 receptors in breast cancer cells cause them to grow out of control, and by interfering with them Herceptin hampers tumor growth.

In July 2012, the British medical regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), discovered during a routine investigation that Roche had failed to inform the government of 15,000 drug-related deaths and another 65,000 side effects caused by Herceptin and other drugs. According to the Daily Mail, adverse events that were reported to Genentech via a call center were not passed up to Roche’s offices in the United Kingdom for the previous 15 years, even though pharmaceutical companies have a legal duty to disclose to regulators all adverse events reported to them. It is unknown what actions the MHRA will take against Roche, but the manufacturer claims that the non-reporting was unintentional.

Herceptin is very profitable for Genentech, and in 2007 it brought the biotech firm $327 million in revenue. A full course treatment can cost $70,000. Genentech claims the high costs are due to the research required to create the drug.

Herceptin Might Cause Heart-Related Side Effects

Herceptin’s drug label contains a black box warning, the FDA’s most serious alert, concerning cardiomyopathy and pulmonary toxicity. According to the “Warnings and Precautions” section, Heceptin can cause:

  • Left ventricular cardiac dysfunction;
  • Arrhythmias;
  • Hypertension;
  • Disabling cardiac failure;
  • Cardiomyopathy;
  • Cardiac death; and
  • Asymptomatic decline in left ventricular ejection fraction.

Herceptin increases the likelihood of these events by four to six times, and the highest absolute increase in heart-related side effects occurs in women who take Herceptin with anthracycline, a chemotherapy drug.

Herceptin’s black box warning also advises physicians to remain on alert for “fatal infusion reactions and pulmonary toxicity.” Symptoms of infusion reactions include:

  • Fever;
  • Chills;
  • Nausea;
  • Vomiting;
  • Pain;
  • Headache;
  • Dizziness;
  • Dyspnea (shortness of breath);
  • Hypotension (low blood pressure);
  • Rashes;
  • Asthenia (weakness and fatigue);
  • Bronchospasm (sudden constriction of muscles in bronchial walls of the lung);
  • Anaphylaxis (allergic reaction);
  • Angioedema (facial swelling); and
  • Hypoxia (lack of oxygen in the body).

In postmarketing reports, fatal infusion reactions occurred between a few hours and days of onset of symptoms. Although the FDA has not done much research on the subject, it notes that a majority of infusion reactions happened to women who were also taking antihistamines or corticosteroids.

Infusion reactions often trigger pulmonary toxicity, which has similar symptoms to infusion reactions:

  • Dyspnea;
  • Interstitial pneumonitis (a type of pneumonia);
  • Pulmonary infiltrates;
  • Pleural effusions (excess fluid in the lungs);
  • Non-cardiogenic pulmonary edema;
  • Pulmonary insufficiency and hypoxia;
  • Acute respiratory distress syndrome; and
  • Pulmonary fibrosis (excess growth of fibrous tissue in the lungs).

A study conducted in the medical journal, Annals of Oncology, found that Herceptin increases the risk of heart problems in elderly users. Prior patient history of heart disease and diabetes worsens the drug’s effects. The study investigated 45 women between the ages of 70 and 92 who used Herceptin, and of them 12 percent displayed symptoms of heart problems traceable to Herceptin use. The researchers calculated that 33 percent of women with a history of heart disease showed symptoms as opposed to 9.1 percent of women who had no such history. Similarly, 33 percent of women with diabetes who used Herceptin developed heart-related problems as opposed to 6 percent who did not have diabetes.

Herceptin Might Cause Birth Defects

Herceptin’s black box warning also advises doctors and users that the drug causes “Embryo-Fetal Toxicity.” The primary birth defect is oligohydramnios, a deficiency of amniotic fluid surrounding the gestating fetus. This condition can lead to pulmonary hypoplasia (incomplete development of the lungs), skeletal abnormalities, and neonatal death.

RLG’s Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Herceptin lawsuit on your behalf if necessary. RLG will also keep you up to date on any Herceptin class action lawsuits, FDA Herceptin warnings, and Herceptin FDA recall announcements.

If you have taken Herceptin and believe it harmed you, contact RLG today.

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