Two different medications from the same manufacturer will get a “black box” warning from the FDA, the Washington Post reported Dec. 11. The FDA issued the warning for OsmoPrep and Visicol, drugs used to clear out the bowels before a colonoscopy, after discovering a strong association between the drugs and acute phosphate nephropathy (acute kidney damage). Both drugs are made of sodium phosphate by Salix Pharmaceuticals. The FDA has ordered the manufacturer to distribute materials informing patients of the problem and conduct a new clinical trial of the drugs.
According to an FDA doctor quoted in the article, the agency has received 20 reports of kidney injury associated with OsmoPrep, with an onset ranging from several hours to 21 days after use of the drug. The agency in 2006 warned patients with kidney problems to avoid the drugs, and has now added children, older patients and patients with certain health problems or taking certain medications to that list. Patients and their doctors can choose alternative drugs not containing sodium phosphate.
It is interesting to me, as a dangerous drug lawyer in Missouri and Southern Illinois, that this is the second warning in two years about this drug and acute kidney damage. The article doesn’t say whether or when Salix and the FDA knew that the high levels of phosphates in the drug could be harmful for everyone. But in general, pharmaceutical companies have a legal and ethical responsibility to disclose serious health risks of their drugs as soon as they know of them. All too often, they choose not to because of concerns about how bad PR could affect their profits.
When manufacturers place their profits over patient safety, they are legally liable for any deaths or injuries that result. Patients who are harmed in this way have the right to file a defective drugs lawsuit to recover their financial costs (including medical costs and time off work they wouldn’t have otherwise incurred), as well as compensation for a wrongful death or permanent disability.
At the Lowe Law Firm, our experienced dangerous drug lawyers have handled many such cases, including a large confidential settlement for six clients who suffered permanent heart damage from using diet drug Fen-Phen. If you or someone you love has been hurt by a drug whose dangers you believe were covered up and you’d like to discuss your case with us, please contact us for a free initial consultation. We offer house calls and hospital calls for potential clients who are not able to travel.
