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Glaxo Hypertension Drug Made at Novartis Plant Recalled
GSK has recalled 394,230 bottles of its DynaCirc CR hypertension drug from the U.S. market after the manufacturer, Novartis, reported inconsistent packaging practices. The generic drug is manufactured at a Novartis plant in Lincoln, Nebraska.
Although Glaxo has received no reports of adverse events and no complaints of contamination or tablet mix-ups, they decided on the recall as a precautionary measure. The London-based company said it does not know when the Novartis facility will resume operations. A GSK spokesman said alternative treatments are available to patients currently being treated with DynaCirc.
http://www.trust.org/alertnet/news/glaxo-recalls-hypertension-drug-made-at-novartis-plant
FDA Rejects Prochieve
The FDA has rejected a vaginal gel from Watson Pharmaceuticals and Columbia Laboratories aimed at reducing the risk of premature birth, the companies said on Monday. The FDA told the companies that the data was insufficient to support approval of Prochieve and that they needed to do additional clinical studies.
The progesterone vaginal gel is for women with a short cervix, who have a higher risk of premature birth. A similar drug called Makena, from K-V Pharmaceutical Co., is already approved to prevent premature birth in women who have a history with the condition.
http://www.reuters.com/article/2012/02/27/us-fda-birth-drug-idUSTRE81Q1LO20120227
Avastin Counterfeits Contained Salt, Starch, and Other Chemicals
Counterfeit Avastin found in Europe and the U.S. earlier this month contained salt, starch, and a variety of chemicals, but none of the life-extending medicine or any other biotech drug, Roche said. Roche analyzed three of the vials and found that they contained none of the injectable cancer medicine's active ingredient or any protein or biologic drug.
http://uk.reuters.com/article/2012/02/27/us-avastin-idUKTRE81Q29X20120227
FDA Exploring Expansion of Rx-to-OTC Switches
The FDA has announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status. The announcement stated:
These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. For example, some conditions of safe use could be designed to assist patients in self-selection of an appropriate medication or provide for follow-up monitoring during continued use. The conditions of use could include requiring pharmacist intervention to ensure appropriate nonprescription use.
Other innovative technologies could include diagnostics approved for use in a pharmacy setting. The FDA stated:
For example, some diseases or conditions might require confirmation of a diagnosis or routine monitoring using a diagnostic test (e.g., a blood test for cholesterol levels or liver function) that could be available in a pharmacy.
http://www.drugstorenews.com/article/fda-exploring-how-expand-eligible-rx-otc-switches-utilizing-pharmacy?utm_source=GoogleNews&utm_medium=Syndication&utm_campaign=ManualSitemap
Added Warnings to Cholesterol-lowering Drugs
New warnings are to be added to the labels of widely used cholesterol-lowering drugs, such as Lipitor, to say they may raise levels of blood sugar and could cause memory loss. This includes the labels of statins such as Pfizer Inc.'s Lipitor, AstraZeneca's Crestor, and Merck & Co.'s Zocor that are taken by tens of millions of people.
More than 20 million Americans were taking some form of statin last year, according to IMS Health. "These are nuances, tiny little tweaks to the label, and the bigger picture doesn't change," said Steven Nissen, chief of cardiology at Cleveland Clinic. Asked what prompted the label changes, FDA spokeswoman Erica Jefferson said they were based on the agency's review of medical literature, clinical trial data, and reports of adverse events.
http://www.reuters.com/article/2012/02/28/us-fda-statins-idUSTRE81R1O220120228
FDA Issues Warning to APP Pharmaceuticals
APP Pharmaceuticals has received a warning letter from the FDA. The FDA inspected the plant in July, citing several "significant violations," including insects found in vials of finished product, products with missing labels, a failure to follow quality-control procedures, and improper investigating of customer complaints. The latest FDA letter says APP failed to properly address or correct the violations in its July response to the inspection. According to the warning letter, APP is manufacturing certain prescription drugs without an approved application.
http://www.buffalonews.com/business/article744342.ece
Legitimate Patients Hurt by DEA Crackdown
A stigma has been placed on pain management as a result of the epidemic of patients selling or misusing their drugs and has caused many doctors to be unwilling to accept legitimate pain patients. Physicians need to be provided with the training to differentiate between legitimate patients and those who would use the medications illegally, especially since studies have shown that the majority of pain patients do not misuse their medications. Some physicians refuse to take on pain patients because of the crackdown, and others refuse because they have too many patients already or they lack the expertise to handle a pain patient's needs.
http://www.pharmacistelink.com/index.php/drugs-and-treatment/1035-crackdown-on-painkiller-epidemic-hurts-legitimate-patients
U.S. Judge Allows DEA to Suspend Cardinal License
A federal judge has allowed the government to suspend Cardinal Health's license to distribute potentially addictive drugs from a Florida facility, part of the DEA's battle against prescription drug abuse. This ruling was an initial victory for government efforts to force drug wholesalers to play a bigger role in fighting drug abuse, and may adversely impact Cardinal's business for the next 12 months.
The Lakeland facility serves about 2,700 drugstores or hospitals and said it was appealing the decision to the U.S. Court of Appeals for the D.C. Circuit. "We want to be part of a new, more effective solution to stop prescription drug abuse, without disrupting legitimate use," the company said in a statement.
http://www.reuters.com/article/2012/03/01/cardinal-idUSL2E8DTDG520120301
http://blogs.wsj.com/corruption-currents/2012/03/01/pharma-code-revamp-follows-us-industry-sweep/
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