GranuFlo, a concentrate used in the treatment of dialysis patients, is responsible for increased risk of heart attack and other serious health problems, according to lawsuits filed against the manufacturer. The drug maker is also accused of concealing the health risks.
GranuFlo and NaturaLyte have been linked to abnormally high blood-levels of bicarbonate, which can cause metabolic alkalosis. Patients and families who believe they have suffered a medical emergency while using GranuFlow should consult a North Carolina law firm experienced in handling medical malpractice and dangerous pharmaceutical lawsuits.
Metabolic Alkalosis is a medical condition that has been linked to heart attack, low blood pressure, problems with heart rhythm and death. The Food and Drug Administration began investigating earlier this year. In May doctors were warned to use caution with dialysis concentrates due to medical error and high bicarbonate levels. And in July, a Class I recall of GranuFlo and NaturaLyte was issued because of the links to heart problems.GranuFlo is an acid concentrate used as an additive in dialysis treatments. It’s administered to patients with severe kidney problems or total kidney failure.
An Alabama man’s GranuFlo lawsuit filed this autumn may be the first nationwide. The suit was served on Fresenius USA INC, and names the GranuFlo manufacturer and several of its subsidiaries. The wrongful death lawsuit alleges the death of the plaintiff’s family member was a direct result of the administration of GranuFlo.
The lawsuit alleges makers of GranuFlo knew about the increased risk of heart attack and other health risks a year ago (November 2011) but did nothing to warn the FDA or GranuFlo patients.
Unfortunately, this is far from an isolated case of a potentially dangerous drug being administered to patients. The FDA approval process has been questioned by patient advocates for decades. Advocates claim that the government watchdog relies upon safety studies and clinical trials performed by drug manufacturers that stand to make billions from drug approval. Advocates also claim that many of these clinical trials occur in Third World countries, far from the prying eyes of regulators.
Johnson & Johnson came under fire earlier this year after being accused of not reporting problems with its insulin pump, which resulted in patients suffering dangerously high blood sugar and respiratory failure. And earlier this year the Government Accountability Office reported that the FDA also needs to increase its oversight of medical products, including stints and artificial joints.
Fresenius USA INC is headquartered in Walnut Creek, California and has about 1,600 employees.
For what it’s worth, FDA approved drugs are often safer than the alternative. NBC News reports the government continues to be concerned about counterfeit drugs and the use of online pharmacies — both by consumers and by clinics and other medical centers.
Too often, these drugs are fake, or contaminated, or expired, according to the government warning issued last month. A survey conducted earlier this year by the FDA found 1 in 4 Internet shoppers had bought prescription drugs online. And there have been several high-profile cases of counterfeit drugs being used to treat patients in the last year. For example, this past spring, cancer clinics nationwide determined they were using fake Avastin, an injectable cancer medicine.
If you have taken GranuFlo or have been harmed by a recalled drug or device or counterfeit drug in North Carolina, contact Grimes Teich Anderson LLP. Call 1.800.533.6845. No Attorney Fees Until You’ve Been Paid.