Lotronex Lawyer: Lotronex Side Effects LawsuitWritten by Anna Henningsgaard
Even in clinical trials, Lotronex displayed a tendency towards causing ischemic colitis in patients. From February in which Lotronex was approved until June, FDA received seven reports of serious complications of constipation leading to hospitalization. Surgery was required to relieve some cases of extreme Lotronex constipation. Lotronex Medication Guides were issued under regulations that became effective in 1999 when Lotronex patients ended up in hospitalization and requiring surgical procedures for constipation. Since Lotronex is a drug used to treat diarrhea, these surgeries were obviously not necessary to treat conditions held before taking drug.
Despite FDA’s issuing of this safety information about Lotronex, patients kept filing severe adverse event reports of ischemic colitis, complications of constipation, death reports, and complications requiring blood transfusions. The FDA recalled Lotronex on November 2000, just nine months after approval.
In 2002, FDA announced approval of a supplemental New Drug Application that allows restricted marketing of Lotronex to treat only women with severe diarrhea-predominant irritable bowel syndrom. The approval of Lotronex includes a risk management program to ensure patients and physicians are fully informed of risks and possible benefits of Lotronex. Patients using Lotronex must sign a contract with their doctors stating that they understand risk of serious constipation that could result in surgery, blood transfusion, or death.
Lipitor Lawyer: Statin Drugs Cause Muscle Damage in 98%Written by Anna Henningsgaard
Doctors have been encouraged to prescribe cholesterol-lowering drugs called statins quite liberally. Patients who suffer heart attacks often have elevated levels of cholesterol, so statins like Lipitor are prescribed to lower cholesterol. There have been no conclusive studies to prove full effectiveness of these drugs, however, and some doctors worry that reducing cholesterol simply takes away warning signs of heart disease. The drug companies also claim that statin drugs have a low, nearly nonexistent incidence of side effects. These claims are based on trials of drug on a carefully screened group of people, hardly a representative selection of general public. Considering rigorous selection process for drug trials, it is hardly a surprise that 51% of prescription drugs found to have serious adverse side effects not detected prior to FDA approval.
As many as 98% of people using Lipitor or similar statin drugs experience muscle weakness. This is because statins break down muscle tissue. A similar drug, Baycor, was removed from market earlier this year after it caused muscle breakdown so severe that patients’ muscles broke down and flooded their kidneys with toxins. Twenty-six Baycor users died from muscle failure.
Though muscle damage, sometimes debilitating muscle pain and disintegration, is most common side effect, statins have been found to cause many other serious adverse effects. Patients taking Lipitor have had a higher incidence of cancer, neuropathy, heart failure, dizziness, memory failure, and depression. The extent of these problems is far greater than anybody realizes because doctors often diagnose these side effects as problems relating to original risk of heart disease, not drug prescribed to treat it.