Wockhardt receives Us Fda approval for cardiac drug

Jul 23, 2010 Full story: Hindustan Times 16

First Published: 15:49 IST Last Updated: 15:55 IST Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration for marketing the cardiac drug.

Full Story
Cassie Scrivner

Ralls, TX

#1 Oct 29, 2010
I have used the generic brand Metoprolol for three years. Three weeks ago my pharmacy changed to their distributor to Wockhardt USA. I was informed the pills would look different.
When I began Wockhardt's version of this med, I started having a heavy feeling in my chest and heart palpatations so severe that I felt as if I were going to pass out.
I contacted my pharmacist and was told to see my doctor. I instead asked for the brand name, Toprol to see if it was the "new" generic causing my symptoms. After only a few hours of taking the brand name Toprol, I was feeling much better.
j o shelby

Sarasota, FL

#2 Nov 15, 2010
I have not had the same reactions but I had taken generic metoprolol for about 15 months when I was changed to this manufacturer's version. My blood pressure is up considerably and I am having irregular heartbeats more consistently than I have in the past.
Sam O

AOL

#3 Dec 16, 2010
I believe Wockhardt USA metoprolol ER is manufactured in INDIA, and got the ok from US FDA.
The quality is not there, the pills dissolve in your mouth before you swallow them. Problem with blood pressure up also and short of breath with this mfg. generic toprol brand called metoprolol ER
Barbara Sartin

United States

#4 Jan 1, 2011
I have had a heartattack 3 years ago had one stent then and have had one more a year later. The Metoprolol Tartrate 25 mg. that I was taking (two a day) about killed me. At work when I stood I could not walk across the room without hanging on something. My legs were so weak and felt as though they would fall out from under me. Several times I almost fell and passed out. I quit taking the metoprolol because I could not figure out what was wrong and I feel better than before. My heart still palpitates and I have continuous chest pain.Please start a law suit. I felt like I was dying and if I had not taken myself off of the medicine I believe I would have been dead today.
Barbara
Richard E Steinberger

Haledon, NJ

#5 Jan 5, 2011
Was having severe BP fluctuations and resting tahcycardias last year, when the FDA pulled existing generic metoprolol succinate ER off the market.A workup including serum catecholamines, renal dopplers, etc discovered no basis for having a secondary cause for this BP control problem. Upon return to the brand RX, my problems resolved. Then, in 2010, generics were again permitted. The first batches I received, from another mfr. were tolerated without incident.
My drug supplier (Medco) has now switched to the Wockhardt( India ) formulation, and I am now experiencing the same problem as before: very poor BP control + AM tachycardia --- I strongly suspect bio-availability and quality control/compounding issues. I am going to discuss this with my MDs to see if a return to the brand (Astra Zeneca) is warranted.
In addition, I will need to discuss advisability of obtaining brand-name Altace(Ramipril)-- however, the current generic is being mfr.'d by Roxane , a subsidiary of Boehringer-Ingleheim. I suspect that is not related to my current difficulties.
(PS: I happen to be an MD, so I do not believe my suspicions are un-merited.)
annette

Cumming, GA

#6 Jan 7, 2011
Boardreader: I have the proof that metropolo killed my mother and the reports and pharma.... records. Now instead of discussing this lets just go after them. We all have some problems lets stop this drug from hurting or killing others. Yoyu can email me at annette.santangelo@gmailcom.
Cheryl Atlanta Ga

Acworth, GA

#7 Mar 8, 2011
After 1 hr, noticed over 35 point increase in systolic BP, heaviness in chest, an increased heart rate, and lightheadedness. Called pharmacist and reported and had prescription changed to metoprolol made by a different drug manufacturer made in the USA. Symptoms went away.
Angie - Texas

Killeen, TX

#8 Mar 11, 2011
Wockhardt lisinopril should be off the market. Blood pressuer spiked, chest pains and headaches. Target said it was their new mfg. and unable to get my old mfg. anymore. I thought I was having a heart attack! Tried my husband's Bp meds. and back to normal in 3 days. Now I have to find a pharmacy who does not sell this brand! Please make sure your doc. marks on prescip. not to use this brand!
Liz kalisiak

Buffalo, NY

#9 May 6, 2011
I have taken metoprolol for a couple of years and did fine. The drug store changed brands to the Wockhardt brand and I feel like my blood pressure is worse than before I started taking blood pressure pills. i hope they will replace the rest of the 90 day supply i bought with something that works...
Susan

Canastota, NY

#10 May 26, 2011
I just got switched to Wockhardt again after finding a pharmacy that had Watson, and that worked okay for me. Everyplace around here has Wockhardt. I'm screwed.
Pam

Kalamazoo, MI

#11 Apr 26, 2012
Have been on Par brand Toprol for 5 years for hypertension without problems. Was switched to Wockhart brand for 3 months....started experiencing extreme fatigue, chest discomfort and shortness of breath. Felt unsteady on my feet at times and would stumble easily. Was driving when I experienced what felt like a sudden drop in heart rate, lasted a few seconds but felt like I was going to die. I have stopped this Wockhart brand and am back on my previous generic. The above symptoms have resolved. Very frightening!!!!
Fred

Arlington, VA

#12 Apr 21, 2013
I take metoprolol for a condition called Hypertrophic Cardiomyopathy (not for my blood pressure). My insurance company's (Cigna) mail order pharmacy recently switched from the Par Lab generic to Wockhard. I immediately noticed a difference -- fatigue, palpitations, and a higher heart rate.

When I was originally prescribed the drug years ago, I was told to only use either the brand name version (Astra Zeneca) or the Par Labs generic version (which is identical to the AZ version). I now see why.
D Resseguie

Tucson, AZ

#13 Apr 29, 2013
Has any one had ringing in the ears?
Jan

Falls City, NE

#14 Aug 15, 2013
My pharmacy recently switched from the Par brand of Metoprolol to the Wockhardt brand. Within 24 hours I started experiencing heart palpitations and a very distinct discomfort in my chest. At first I thought it was just a one time event, then the palpitations got worse and I had pains up into my carotid arteries in my neck, like a pressure. It did occur to me that this brand may be of lesser strength, so I took 2 one day. Wrong thing to do. Condition worsened...palpitations more uncomfortable, became light headed and dizzy, could not sleep. I had my B/P checked and it was OK, higher than previously, but not overly high. My pulse felt like it was pounding, it was faster than previously, but not overly. I quit taking the pills after suffering through 8 days of this. I felt like I might die. I asked my pharmacy if they could get the Par brand back for me and they did order them for me. I would not trust this brand ever again.
Chitreana

North Little Rock, AR

#15 Dec 1, 2013
I am so tired of this companies since I starts taking metropolol made by Woodhardt for my hypertension. I have been having a lot of chest pains as well as shortness of breath for which I have complain to my doctor about the problems but it turned out that on September 27 the USFDA banned Wockhardt who are the makers do metropolol now I have been change to another company , I think it's very sad that in March of this year there. Warning letter sent to the. In regards to this particular company and they took all this time to banned that company what in the worlds is wrong with this people? Is the peoples life that you are playing with it's my life too ,my blood pressure medicine has been change about four times and now I found out that the one I was taking was just as wrong as the previous ones NOT FAIR
sunny

Santa Rosa, CA

#16 Jan 6, 2014
WE ALL HAVE TO REPORT THE HAIR LOSS SIDE EFFECT TO THE FDA. I asked my pharmacist at Kaiser about the hair loss side effect. He looked up his protocol and said there was no side effect of hair loss for Metoprolol. I said, "I am on a blog with hundreds of people who are having serious hair loss!" He looked again and said, oh now he sees it. The company doesn't report it but there are some complaints filed by users." No kidding. So he said I should talk with my cardiologist about it. I have. Cardiologists don't care about your hair - they only care about your heart. Action has to come from somewhere else.

Google: How to report drug side effects to FDA.

We ALL have to do it.

"Reporting Problems Can Spur Action
If a person reports an illness or injury that appears likely to be caused by an FDA-regulated product, FDA acts immediately. Depending on the seriousness of the problem, an FDA investigator may visit the person who made the complaint, collect product samples, and initiate inspections.

"Just a few complaints can make a difference," says Joan Trankle, FDA's National CCC. For example:

CCC's in different parts of the country received three reports of allergic reactions to a type of soymilk. FDA followed up with an inspection of the soymilk company. The product did not declare the allergenic substance, milk protein, on the label, and the company recalled the product.
CCC's received two complaints in one week about skin burns after use of an adhesive patch that generates heat to relieve muscle and joint pain. "When that second complaint arrived, we sprang into action," says Trankle. "We contacted the firm and, based on our follow-up, the firm recalled the product."

Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and the information is used during a future inspection of a company to help FDA identify problem areas in a production plant. The complaints are also discussed with company management during these inspections."

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