FDA declines to approve Takeda diabetes drug
DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.
Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.
A complete response letter means that the FDA has finished reviewing a drug approval application, but questions remain that preclude approval. In this case, the agency requested additional data about the drugs, which Takeda said it would supply from clinical trials.
Takeda drug Actos has been linked to bladder cancer and this is still being investigated by the FDA
Quest Diagnostics: Rx misuse recorded among majority of Americans
MADISON, N.J. — A recent Quest Diagnostics "Health Trends Report" released Wednesday found that more than 3-in-5 patients (63%) misused their prescription drugs.
After analyzing nearly 76,000 laboratory tests for monitoring prescription drug use, Quest Diagnostics said the findings suggested many Americans take prescription medications in ways that put their health at risk, including such behaviors as missing doses to combining medications with other drugs without a clinician’s oversight. The study found high rates of inconsistency with clinician orders among all specific drug classes tested, including opioid pain medications, such as oxycodone (including OxyContin) (44%); central nervous system depressants, including alprazolam (as well as Xanax) (50%); and the stimulant amphetamine (such as Adderrall) (48%). What’s more, high rates of misuse were found in men and women across all ages, income levels and government and commercial health plan coverage.
Specific findings included:
As many as 70% of children ages 10 to 17 years and 73% of adults ages 18 to 24 years were inconsistent with clinician orders. Older patients also were at risk of misuse, with inconsistent results found in 50% of adults ages 65 years or older that were tested;
Men and women were as equally likely to misuse drugs, with inconsistency rates of 63%, although males used illicit drugs more, with 2-in-10 (21%) testing positive for cocaine, marijuana or PCP, compared with 15% of females;
Inconsistency rates were similar for low-income areas (median income of $29,000 or less) and high-income areas (median income of $80,000 or more), although patients at the lowest income level were more likely to test negative for their prescription drug(s) than those at the highest income level (42% compared to 35% inconsistency, respectively). The findings suggest that less affluent Americans may be more likely to limit or forgo using their prescribed medications for financial reasons. Median income was based on 2010 U.S. Census data by ZIP code;
Evidence of misuse was found in 72% of samples of Medicaid beneficiaries, compared with 60% of patients in Medicare and 62% in a private health plan.
"The current study from Quest Diagnostics, involving a large nationally representative sample of patients undergoing urine drug testing, suggests that many patients do not take potentially dangerous prescription medications as prescribed," said Keith Heinzerling, assistant professor with the UCLA department of family medicine and UCLA Center for Behavioral and Addiction Medicine. "The study provides a unique perspective on the problem of prescription drug misuse by comparing what the doctor indicates is the patient’s prescribed medication to what is actually in the patient’s urine test. These results are sobering, and suggest that changes in prescribing medications — and educating patients in appropriate prescription drug use — are urgently needed."
The entire report now is available at QuestDiagnostics.com/HealthTrends.
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Report: Preliminary injunction to block ESI-Medco merger denied
PITTSBURGH — The U.S. District Court for the Western District of Pennsylvania on Wednesday denied a preliminary injunction filed by pharmacy trade groups in an effort to block the merger between pharmacy benefit managers Express Scripts and Medco.
According to a Reuters report, U.S. District Judge Cathy Bissoon, who said earlier this month she would rule "later" on whether to block or allow a merger between the PBMs, declined to issue the preliminary injunction, which would require ESI to divest or separate Medco. A decision regarding a permanent injunction has not yet been made.
As previously reported, the Federal Trade Commission approved the deal despite efforts from the National Association of Chain Drug Stores, the National Community Pharmacists Association and several other retail pharmacy companies to block the merger. Consumer groups, including the Consumer Federation of America, the National Consumers League, the National Legislative Association on Prescription Drug Prices and U.S. PIRG (a federation of 28 nonprofit, nonpartisan state Public Interest Research Groups), filed an amici curiae on behalf of retail pharmacy plaintiffs in their suit to dismantle the ESI-Medco merger.
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