- Category: Side Effects Lawsuit
Carboplatin Side Effects Lawsuit Information
Chemotherapy drug Carboplatin, used by hundreds of patients in their fight against cancer, can create a number of life-threatening health complications. Sold under the trade names Paraplatin by Bristol-Myers Squibb and generic Carboplatin, the cancer drug leads the list of adverse events associated with chemotherapy medication. At least 376 adverse event reports were registered with the FDA MedWatch system in 2011 while the manufacturers received complaints of more than 150 instances of serious Carboplatin side effect injuries. The 2011 QuarterWatch surveillance report on prescription drug side effects prepared by the Institute for Safe Medication Practices ranks the drug No. 4 on the list of most reported medications for side effects.
Often considered to be a safer drug, with less side effects, compared to more powerful chemotherapy drug Cisplatin, Carboplatin is associated with the increased risk of myelosuppression, immune system problem, and adverse hematologic effects. In the past one decade, the FDA has received a large number of complaints linking the chemotherapy drug to several complications, such as lower respiratory tract infection, pathogen-linked infections, hematology disorders, renal disorders, and decreased WBC count. Carboplatin can also cause fatal health problems, including interstitial lung infection, pyrexia, myelodysplastic syndrome, reduced platelet count, sepsis, and malignant neoplasm progression.
History of Carboplatin
Carboplatin Fact File
Generic Name: Carboplatin, Trade Name: Paraplatin
Carboplatin Use: Chemotherapy drug to treat ovarian cancer and secondary use to treat lung, neck, and other types of cancers
Manufacturer: Bristol-Myers Squibb, NYC, USA
Year of Approval: March 1989; generic version in October 2004
MedWatch Complaints: 376 directly and 140 by manufacturers
Major Carboplatin Side Effects: Nephrotoxicity, myelosuppression, neutropenia, kidney problems, immune system problem, ear damage, respiratory tract infection, gastrointestinal perforation, etc.
Carboplatin Warning: FDA dosage communication October 2010;
Carboplatin Recalls: Hospira Carboplatin injection recall, July and Dec 2012, following discovery of crystals
Carboplatin Side Effects History
Carboplatin was first discovered in the 1970s following a research study conducted at Michigan State University to find the efficacy of platinum compounds in subduing cancer. The London-based Institute of Cancer Research, in its quest to develop platinum-based chemotherapy drug with lesser side effects compared to Cisplatin, developed Carboplatin. In 1981, the first clinical trial of Carboplatin was carried out, and Bristol-Myers Squibb acquired the patent for it. In March 1989, the FDA allowed BMS to market Carboplatin chemotherapy drug under the trade name Paraplatin. The federal regulator gave its approval for introduction of the generic version in October 2004.
Carboplatin is a platinum-based alkylating agent. It interferes with cancer cells at molecular level by damaging their DNA. The drug follows a methodology called apoptosis or self-destruction of cancer cells. Its chemical reaction with amino nitrogens led to the formation of aquated spcies that destroy DNA of cancer cells and prevent their growth.
The FDA approved Carboplatin intravenous chemotherapy drug for the treatment of ovarian and lung cancer. However, the drug is widely used alone or in combination with other drugs to treat cancer, affecting breast, head, neck, bladder, testicles, esophagus, the lymph system, brain, and certain types of skin and eye cancers.
Carboplatin Side Effects
Carboplatin inhibits bone marrow activity that results in reduced blood cell count. Fall in the white blood cell and platelet count may starve cells of oxygen and expose them to infections. Patients experience fever due to infections, anemia, myelotoxicity, fall in platelet counts, and neutropenia, and leucopenia. Deficient blood production exposes the patients to various hematologic side effects.
Immune System Deficiency
Myelosuppression leads to low WBC count, which weakens the immune system. As a result, patients face the risk of recurrent infections that can be life threatening. Intestinal, lung, respiratory tract, and sepsis infections often attack patients.
Reduced Platelet Count
Carboplatin causes reduction in blood platelet count. This impacts the blood clotting ability of our body. Abnormally low platelet count put patients at the risk of bruising, internal bleeding, and loss of blood. Reduced platelet count may also cause dizziness and fatigue.
Nervous System Damage
Carboplatin damages nerves and tissues, which impacts the normal functioning of the central nervous system. Cancer patients treated with the chemotherapy drug experience numbness, tingling sensation, injection site pain, peripheral neuropathy, skin sensation, and cumulative neurotoxicity.
Low Electrolyte and Toxicity
The drug has been linked to falling electrolyte level in the body caused by wastage of magnesium, calcium, and phosphate. Carboplatin also creates peripheral neurotoxicity, nephrotoxicity, and audiologic toxicity that can be fatal for senior citizens.
Patients treated with Carboplatin are at a risk of hypersensitivity manifesting in breathing difficulty, hypotension, skin problems, and increased heart beat. People treated with six or more chemotherapy cycles are more at the risk of hypersensitivity side effects.
Renal side effects of Carboplatin include kidney impairment, creatinine and urea abnormalities, and other reversible complications. The drug can also cause acute renal failure aided by limited nephrotoxicity. The risk is greater for those above 65 years.
Other Carboplatin Side Effect Injuries
- Loss of vision and blurred vision
- Interstitial Lung Disease
- Ototoxicity and hearing loss
- Liver abnormalities
- Gastrointestinal puncture and hemorrhage
- Myelodysplastic Syndrome
- Cerebral Infarction
- Cardio-respiratory Arrest
- Septic Shock
- Acute Respiratory Distress Syndrome
- Chest Discomfort
- Gastrointestinal Necrosis
Carboplatin FDA Warnings and Recalls
In October 2010, the FDA issued new guidelines on Carboplatin dosage depending on serum creatinine measurement of patients. It warned the US oncology professionals that failure to adhere new guidelines was likely to cause inappropriate dosing which could result in kidney impairment.
In July and October 2012, the FDA asked Hospira Inc. to recall certain lots of Carboplatin injections following discovery of crystal-like particles in vials.