Adverse Event Report

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Bobbie
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Adverse Event Report

Postby Bobbie » Sat Mar 22, 2014 5:20 pm

If a medication contributed to your case, please fill out an Adverse Event Report online at: http://www.fda.gov/Safety/MedWatch/default.htm. Under "Resources for You," in left-hand column, click on "Report a Serious Medical Product Problem Online." (Allison provided this information.)

magnaboy
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Re: Adverse Event Report

Postby magnaboy » Sat Feb 13, 2016 5:20 am

Those of us in Australia can report adverse events here: http://www.tga.gov.au/report-side-effect-medicine

Bobbie
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Re: Adverse Event Report

Postby Bobbie » Sat Feb 13, 2016 3:07 pm

Thx for the info.

PattieF
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Re: Adverse Event Report

Postby PattieF » Thu Sep 22, 2016 12:01 pm

I'd be curious to know how many people got C-diff from medication like Clindamycin. Perhaps we could do a survey on this site? And subsequently, if there has been any thought as to lawsuits? I am very angry about having this illness for going on 5 months now - which was totally preventable! I blame myself too for not being more aware too. However, doctors and pharmacists should not prescribe or dispense this medication without STRONG warnings about the possible consequences.

iamsick
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Re: Adverse Event Report

Postby iamsick » Thu Sep 22, 2016 3:32 pm

Patti, your story sounds like mine. Clindamycin cased my cdiff also and I was angry with my doctor of 20 yrs and pharmacist for not warning me of the dangers of this drug. They did however warn me after I contracted cdiff and was place on Flagyl, DO NOT DRINK ALCOHOL WHILE TAKING THIS OR YOU WILL GET VERY SICK! What the hay! I have yet to visit my primary doctor since and am still stewing.
Teresa_68

Ril
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Re: Adverse Event Report

Postby Ril » Thu Sep 22, 2016 3:54 pm

I also got c diff from clindamycin taken for a skin infection from an insect bite prescribed because I am allergic to tetracycline. Worst yet, as a nurse I know the danger. The danger of c diff is listed in possible complications in the pharmacy handout and manufacturer's warnings, as it is for all broad spectrum antibiotics. I suspect that legally that covers it. Mine was prescribed by an urgent care dr and phoned to the pharmacy.

AllisS
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Re: Adverse Event Report

Postby AllisS » Thu Sep 22, 2016 4:17 pm

I was also a victim of clindamycin. I think the idea of a survey is a good one, though not sure how it could be set up on this site. As for legal action, Rita, you may be correct that the fact the package insert lists C.diff as a possible side effect would preclude manufacturer liability. However, per FDA's own information at http://www.fda.gov/downloads/ForConsume ... 107976.pdf, a black-box warning "appears on the label" of the drug, not merely on the package insert, which uses type font of about .0000005! To my knowledge, the C. diff warning for clindamycin is not yet of the black-box type. Can anyone who has an Rx for it on hand confirm this? If accurate, I think it's worthwhile to continue to urge everyone on this site who contracted C. diff from clindamycin to fill out an Adverse Event Report. It would also be interesting to "talk with a human" at FDA (if there are any) and try to find out what it considers a critical mass of people who have been harmed by a drug before requiring the black-box warning.
If your illness was preceded by use of a medication, e.g., an antibiotic, please fill out an FDA Adverse Event Report at http://www.fda.gov/Safety/MedWatch/default.htm

roy
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Re: Adverse Event Report

Postby roy » Thu Sep 22, 2016 4:18 pm

USA recorded victims are close to 500,000 a year. (Probably more).
The legal side is covered by the pack insert that says it may cause c.diff.
BUT until you get it you don't know what it is or why you got it!

PattieF
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Re: Adverse Event Report

Postby PattieF » Fri Sep 23, 2016 12:16 pm

Roy, 500,000 a year? After taking Clindamycin? Or total episodes. Regardless it's too much.
Thanks everyone for the response. I usually read all the info on my prescriptions and don't remember seeing the warning about c diff. I hope the powers that be take the information in our Adverse Event reports seriously. Still doctors and pharmacists should provide strong warnings. My husband picked up the Rx and probably declined when asked if he wanted to talk to the pharmacist (a little bit of anger in me for that.. ) but the pharmacists should insist on this medicine. I did talk to her later and she said she would have warned me about it. Hindsight, sigh.
Survey results on this site would be interesting...

tonia
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Re: Adverse Event Report

Postby tonia » Fri Sep 23, 2016 2:30 pm

Hi Pattie. I also am a victim of clindamycin. Only 2 pills set off this chain of events for me. The real kicker is, I should never even have been given it. I had visited a family member for an hour in a hospital setting. We later found out he had bacterial meningitis. My dr in his infinite wisdom said if I did not take the clinda, I could end up in a coma like the family member. Turns out, what he had was not even contagious. My dr panicked and I paid the price. Also, no warnings about this med and I had never heard of c diff to know to question it. So sorry you have to go through this too.

PattieF
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Re: Adverse Event Report

Postby PattieF » Sat Sep 24, 2016 1:00 am

Tonia, I had never heard of c diff before either and wish I hadn't! Clindamycin should not be prescribed so readily. From what I have gathered here it has caused a lot of misery - perhaps more than any benefit or relief.
Allis, a black box warning on the label would be the least that could be done for sure.
Iamsick, I haven't had any alcohol since all of this started... I'm pretty sure my gut couldn't tolerate it. The list of things I can eat is pretty limited. I can relate to the anger.
Ril, I guess legally the manufacturer is covered. But if there is more they could/should do then they better get on it.
I'm sorry anyone has had to deal with this and I wish us all health and vitality!

georgina
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Re: Adverse Event Report

Postby georgina » Sat Sep 24, 2016 3:18 am

Pattie , totally agree with you , i would love to see Clindamycin removed from the drug market , or at least the dentist to stop prescribing it for any small tooth infection that doesn't even require antibiotic treatment. It has put many in hospital and some are even dead because of it : Peggy Lillis for example .

PattieF
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Re: Adverse Event Report

Postby PattieF » Sat Sep 24, 2016 12:46 pm

Georgina... it is sad and needless. Which is why we need to get the word out. I don't share my personal health struggles on Facebook, but I did share that Clindamycin should be avoided at all costs! A friend of mine who is in the pharmaceutical industry said that it is one of the only drugs that can be used for MSRA. I say, save it for that. I am telling all my friends, doctors and pharmacists. If the manufacturer can't provide better information or stronger precautions - then we must! I do wish we could sue them - just to get them to warn people and physicians better! Alas...

MKW
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Re: Adverse Event Report

Postby MKW » Tue Sep 27, 2016 7:04 pm

I wanted to add here, I also developed C Diff after taking Clindamycin from my dentist. The truly sad part is that I probably didn't even need to take it. During a standard dental cleaning my very inadequate hygienist complained to the dentist she saw possible infection in my gum around a tooth. It didn't even hurt. So the dentist said I probably had gotten something stuck in gum, but here.. take this.. and she wrote me a Clindamycin prescription. She then said if I developed diarrhea to give her a call. I saw the warning label and read it. But I think we are all used to rare side effect warnings with drugs and usually ignore them. And here I am, starting Vanco after a second recurrence of C Diff which I have been dealing with for 2 months now. I was perfectly healthy before this - age 45, fit, on no medications. What I have discovered since is that C Diff from Clindamycin is extremely common. And obviously dentists are prescribing it too commonly and unnecessarily. I would love to see a survey done on this site also.

AllisS
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Re: Adverse Event Report

Postby AllisS » Tue Sep 27, 2016 11:47 pm

I hope you find a different dentist. This one sounds like bad news.
If your illness was preceded by use of a medication, e.g., an antibiotic, please fill out an FDA Adverse Event Report at http://www.fda.gov/Safety/MedWatch/default.htm


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