Posts Tagged ‘FDA’

iGuard Medication Alerts

09/18/2008 , 9:29 AM by Alex Sicre

Do you know about iGuard? I never want to sound like a salesperson, but it is a great service “launched in 2007 as a startup venture funded by Quintiles Transnational…to promote better communication and research about drug safety.” Huh? A little bit of hype, and you wonder, how are they going to do that?

On the surface, iGuard is a DDI checker, “a healthcare service that helps monitor the safety of your medications (including prescription drugs, over-the-counter drugs, nutritional supplements and herbal extracts)” like ePocrates, DoubleCheckMD and PharmaSurveyor, but has a lot of other benefits as well. FD I know and have spoken with representatives from all of these companies – and they all do more than just check for drug interactions. I am just placing them in this category for now.

I signed up for iGuard a few months back, seeing if there was any synergy with Intelecare and kind of forgot about it, as I know the drugs I take do not have any interactions with each other. A few days ago I was twittering about another Health 2.0 company, and a VP of Quintiles pinged me to ask if I had heard of iGuard. I replied I had an account and went back to look at it again.

Users add the medications they are taking, and their health problems to see if there are any side effects, and then can get information about said meds and conditions. The interface for the medications is very user friendly with Wikipedia content, prescribing info, indications, fact & figures, side effects, as well as charts based on other users on the same drug and feedback from other patients.

For Niaspan ER, the health information is very straight forward: “This product is used in the treatment of patients with high lipid levels (including cholesterol). It’s exact mechanism of action is not well understood.” I did not know that researchers and MDs did not know how Niaspan works! Learning already. My risk rating is 2, meaning no harmful long-term side effects or interactions. 2,630 patients using iGuard take Niaspan, 53% have side effects (flushing being the most common), 7.0 satisfaction score (mine is a 9), etc… Point being, lots of great information, and a anonymous comment board to post.

This is what got me thinking about them today however, an email from them that stated the FDA is stopping the import of medicines from Ranbaxy Laboratories due to the concerns they are not following US standard for good manufacturing practices. Here is part of the email:

“Although Tricor is one of the medications manufactured by Ranbaxy, drug shortages are not expected because, in most instances, there are enough other suppliers that can help meet demand for Tricor.

For more information, please visit:

http://www.fda.gov/cder/drug/infopage/ranbaxy/qa.htm

* * * *
WHAT DOES THIS MEAN?

This alert will have very little impact on most patients. However, you should be aware that your pharmacy may dispense Tricor manufactured by a different generic company the next time you get your prescription filled.  The effectiveness and safety of generic medication is equal, but some tablets or capsules look different depending on the manufacturer. If your prescription ever looks different, it is always a good idea to ask your pharmacist why the tablets or capsules look different.

This alert is not related to any safety concerns with Ranbaxy products currently distributed in the United States. If you are using medicine covered by this alert you should continue to take it as directed – the risk of suddenly stopping this medication is likely to be greater than any risk associated with their manufacturing. If you have any additional questions about how this FDA alert affects your medications, please talk with your pharmacist.”

I got this email at 7:45 pm last night, after I had “shut down” for the day – and stopped inputing information via the web. I read this around 11 pm and thought wow, this is great. Of course I could get this news with the information I read throughout the day, however it was presented to me before the news broke, and provided me with a calm, knowing that I would be OK with my Tricor.

FDA To Hire More Staffers for Generic Application Processing

10/09/2007 , 11:19 AM by Alex Sicre

just thought this was interesting. Off the AP Wire.

WASHINGTON_The Food and Drug Administration on Thursday unveiled a plan to speed up the approval of generic drugs and address a backlog of hundreds of applications.

FDA officials outlined a half dozen recent changes that it said will streamline how the agency processes applications for cheaper versions of branded drugs.

Perhaps most significantly, FDA said it would immediately begin processing applications for generic drugs that have lost patent protection. Previously these applications would sit in a queue behind applications for drugs that might still be patented for years.

FDA also said it hopes to hire additional employees beyond the 215 staffers who currently review generic drug applications. Whether FDA has funding to hire new reviewers depends on whether Congress approves the agency’s budget request later this year.

Unlike makers of traditional drugs, generic drug companies do not pay user fees to help offset the cost of hiring drug reviewers. Efforts to set up generic drug user fees have been opposed by the Generic Pharmaceutical Assocation, whose members include Barr Pharmaceuticals Inc., Mylan Laboratories Inc. and Teva Pharmaceutical Industries Ltd.

The industry group reacted coolly to FDA’s initiative, saying the best way to speed up generic drug approvals is to outlaw tactics which branded companies use to protect their drug patients.

“For years, the agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results,” said Kathleen Jaeger, the group’s president. “There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market.”

More ADHD Adherence News

09/06/2007 , 10:58 AM by Alex Sicre

I picked this blip up from spiritindia.com, which calls itself “an amazing health tech site”. I’ll look into it more.

The Food and Drug Administration approved Alliant’s Methylin Chewable Tablets and Methylin Oral Solution and the pediatric specialty pharmaceutical company said the goal is to increase compliance.

Dr. Lyndon Waugh of Emory University said children often have difficulty swallowing pills so the new offerings could help ensure they take their medication. It’s estimated up to 26 percent of the general population has difficulty swallowing tablets and capsules and the percentage is considered higher for children.

ADHD is a brain disorder that causes children to exhibit inappropriate impulsivity or inattention. It is estimated that 7 percent of school-age children and 4 percent of adults suffer from ADHD, one of the most commonly reported behavioral problems.

My Comment

When I was young (34 now), I had the Flintstone chewable vitamins, as well as the St. Joseph’s aspirin, so does this really come as a shock that kids have a difficult time with tablets and pills? Luckily I never suffered from ADHD or any deficit disorders, but hasn’t that been the “easy” diagnosis for doctors for many years now? But 7% doesn’t seem that high. Maybe I’m confused with ADD?

I know the parameters for diagnosing autism in children have gotten less stringent, raising the diagnosed numbers. But shouldn’t ADHD be higher as well?

All I know if that anything pharma does to increase adherence is OK in my book.