Supreme Court to hear Wyeth’s Vermont preemption case
WASHINGTON The Supreme Court has granted review to Wyeth in regards to a case where the state of Vermont awarded a $6.8 million verdict to a woman whose arm had to be amputated after being injected with the company’s anti-nausea drug Phenergan, according to published reports.
This will be the second case heard by the Supreme Court regarding the Food and Drug Administration’s approval of drug labeling and whether that preempts state law. In the first case, Warner-Lambert v. Kent, patients who claimed to have suffered personal harm from the Type 2 diabetes drug Rezulan alleged that the drug company concealed the safety information from the FDA.
Wyeth is stating that it should not have been subjected to the lawsuit because the company had approval from the FDA for the warning label that accompanied the drug.
Wyeth has even said the company recommended a label change to the FDA, but the agency told it to keep the existing language.
Lawyers for the drug industry have said that the FDA and not jurors should have the role of deciding when drugs can be used safely.
Study shows positive results from adding Lipitor early to blood pressure treatment
NEW YORK According to a new study, when Lipitor was added as an early treatment to lower blood pressure, the drug showed a 36 percent reduction in the risk of fatal or non-fatal heart attacks over five years.
The study, entitled Anglo-Scandinavian Cardiac Outcomes Trial, was conducted over a five-year period in Europe with over 19,000 patients, with the first three years being dedicated to comparing Lipitor, a Pfizer product, with a placebo. The additional two years were used for post-study follow up. At the start of the study, patients had high blood pressure and additional cardiovascular risk factors but no coronary heart disease.
“This study highlights the importance of initiating medical treatment for both blood pressure and cholesterol as soon as possible, and raises questions about medical guidelines that do not focus on early intensive treatment of multiple risk factors, notably blood pressure and cholesterol, in patients with moderate cardiac risk,” according to Bryan Williams, chairman of the British Hypertension Society Guideline working party and professor of medicine, University Hospitals NHS Trust, Leicester, United Kingdom.
Patients in ASCOT-LLA had normal to mildly elevated cholesterol levels, were not candidates for lipid-lowering treatment at the time of the study initiation, and received Lipitor 10 mg or a placebo at the outset of the trial.
At the end of the follow-up period, LDL-C or bad cholesterol levels were similar in both groups as a result of Lipitor treatment and the average blood pressure level was significantly reduced from 164/95 mmHg to 137/78 mmHg with the blood pressure lowering therapy.
Taro submits Flo-Pred application to FDA in new PLR format
WASHINGTON Taro Pharmaceuticals applied Thursday to the Food and Drug Administration seeking approval for its new oral solution, Flo-Pred.
Flo-Pred (prednisolone acetate oral suspension) is an anti-inflammatory or immunosuppressive agent indicated for a variety of diseases and conditions, including allergic, dermatologic, gastrointestinal and hematologic.
The medication also enjoys the distinction of—pending approval—being the first oral steroid label in the FDA’s new physician labeling rule format. The PLR format, which went into effect June 19, requires new content, new structure and new highlights information, as compared to the former structured product labeling.