FDA safety review

FDA Evaluates Hip Implant Safety Issues Affecting 500,000 Americans

Recently, the news has been filled with stories of individuals who have been forced to suffer because their metal-on-metal hip implants failed.  This failure has been happening at rates far greater than would be acceptable to the medical community, and the problem became so rampant that recalls were issued. Now, the Food and Drug Administration [...]

Eliquis Approval Delayed Until More Drug Trial Information is Given

A blood thinner that could benefit those suffering from a certain heart condition has had its approval delayed for the time being by the Food and Drug Administration. The drug in question is Eliquis, which is jointly produced by Pfizer and Bristol-Myers Squibb.  The drug aims to reduce the risk of blood clots which lead [...]

Genotoxicity Testing Gets New Guidance From FDA

The Food and Drug Administration is offering new guidance that pharmaceutical makers will be required to follow in order to get their items approved for use. The new guidance is labeled as Genotoxicity Testing and Data Interpretation for Pharmaceuticals.  It will replace two previous guidances called S2B Genotoxicity, a Standard Battery for Genotoxicity Testing of [...]

FDA Worried About Efficacy and Safety of Carfilzomib Cancer Treatment

The Food and Drug Administration has expressed concerns that a drug seeking approval might be more trouble than it’s worth. The drug being considered for approval is known as carfilzomib.  Its makers, Onyx Pharmaceuticals, were hoping that they could get the drug approved for the treatment of multiple myeloma, a rare type of cancer that [...]

Outlook Not Good on FDA Approval of Semuloparin Blood Thinner

The Food and Drug Administration needs more information before they can approve a new drug for the prevention of blood clots in individuals who are in the process of undergoing chemotherapy. The drug being considered is a blood thinner known as semuloparin.  Produced by the Paris-based Sanofi, it was hoped by the company that the [...]

FDA To Consider Approval of Laser Labeling For Produce

If you’ve been to the grocery store to buy produce, you’ve no doubt come across the stickers that are placed on each item to designate what kind of fruit it is.  But if a new report is any indication, those stickers could soon become a thing of the past. The Food and Drug Administration has [...]

FDA Proposes New Labels To Be Placed on Drugs With Albumin

The Food and Drug Administration is planning on adding new warning labels to certain types of drugs.

The comment period has opened up on the FDA’s proposed plans to mandate various labeling requirements on drugs that contain what’s known as albumin.  Any drugs which have albumin, which is derived from plasma, will now have to have labels that reflect the FDA’s worries about the transmission of various viral diseases.

In 2010, the FDA added various labeling requirements for blood transfusions.  These labels targeted the potential risk of spreading Creutzfeldt-Jakob Disease (CJD).  This latest decision extends those warnings even further to the aforementioned albumin products.

If the FDA decision becomes final, then drugs that have albumin derived from plasma will carry a similar warning about Creutzfeldt-Jakob Disease, as well as a warning regarding the transmission of other viral diseases.  Any risk appears to be incredibly remote, but the FDA looks to be erring on the side of caution.  In fact, the new labels will specifically talk about how the risk is only theoretical at this point.

Products that don’t contain albumin but are still derived from plasma get a slightly stronger warning.  Since such items are created using human blood, the new labels will reflect the risk of the transmission of viruses, infections, and CJD.

Concerned individuals have until September 10 to provide comments to the FDA.

FDA Calls Out Deficiencies in Sapien Heart Valve Clinical Trials

A new medical device is facing a potential hurdle following a Food and Drug Administration review that called into question the safety of the item.

The product in question is the Sapien heart valve manufactured by Edwards Lifesciences Corporation.  The Sapien is intended to be used as an alternative to surgery in order to correct a condition known as aortic senosis.  Aortic senosis is what occurs when a restricted valve impedes the blood’s pathway to the aorta.  Currently, the Sapien is approved for use in patients who are unable to get open-heart surgery, but its makers are seeking approval for patients who are eligible for surgery yet face a heightened risk of an adverse condition.

The FDA worried that the trials that were conducted may have been biased at the categorization level.  Eligibility seemed to vary depending on the location that each trial was held at, and certain researchers may have stood to gain financially from the approval of the device.  Those researchers could be responsible for bringing in 30% of all patients enrolled.  In addition, an inordinately large number of people either died or withdrew prior to the implantation of the device.

There also appears to be a heightened risk of stroke in the first 30 days, or the first year in cases where patients opt for an arm incision rather than a leg incision.  If the study is eventually approved, the FDA has recommended a post-approval study to monitor patients.

Reports of Adverse Drug Reactions Rise From Previous Levels

Adverse reactions from drugs are on the rise.

According to a new report from the Institute for Safe Medication Practice’s Quarterwatch surveillance program, 179,855 reports came flooding in to the Food and Drug Administration regarding serious or fatal reactions to drugs last year.  This is a marked increase of 9.4% from the previous year, when there were 15,000 fewer reports.  Of the 2011 reports, just over 21,000 came from consumers or medical professionals, while the rest came from manufacturers, who are required by law to report any adversity to the FDA within 15 days of learning of a problem.

Of the drugs that topped the list in terms of the most reported adverse events, many are also incredibly popular and widespread among patients.  Those drugs that topped the list of reports from consumers and physicians include Zocor, Carboplatin, Zestril, and Bactrim.  Topping the list with 3,781 adverse reports was Pradaxa.  Included amid these reports were 542 deaths and 2,367 reports of a hemorrhage taking place.

The increase in reports of adverse drug events may have to do with the advent of the internet and various other communications platforms.  Because manufacturers now have the ability to communicate directly with consumers and healthcare professionals alike, it’s becoming easier for these companies to hear more about adverse events, thus leading to increased reporting numbers.

FDA Panel Advises Against Xarelto Approval

Going against the opinion of one of the Food and Drug Administration’s drug reviewers, an advisory panel opted to vote against the approval of a potential blood thinner medication.

The drug in question is called Xarelto (rivaroxaban).  Already on the market for a couple other conditions, its maker was hoping to gain approval to to market the drug for use in preventing blood clots in those individuals who suffer from acute coronary syndrome.  In documents that came to light earlier this week, an FDA drug reviewer advised approval of the drug.  Despite a potential increase in internal bleeding, the reviewer thought that trial data successfully proved a decrease in cardiovascular death.

But an advisory panel that met yesterday disagreed with his conclusions.  In a 6 to 4 vote, they voted against allowing the drug to be marketed in this new way.  They believed that there weren’t sufficient amounts of data which showed the definitive benefit that the product would have.

The panel worried that minor bleeding events weren’t considered in the research conducted to prove the drug’s efficacy.  They thought that, although not necessarily fatal, these events would still require medical treatment that could include rivaroxaban therapy.

Although they voted against approval, that’s not the end of the line.  The FDA will meet and likely make a final decision by June 29.  They are not required to heed the advisory panel.


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