3 comments to “Serious Concerns Raised Over FDA’s Capacity to Inspect Overseas Drug Makers”

  1. Charles D Sherman

    This report could be buttressed with an authoritative list of generic drugs pulled from the market. Valsartan, a widely used treatment for hypertension, was recalled for containing cancer-causing chemicals.

  2. Is your drug safe? — New York Personal Injury Attorneys Blog — January 15, 2020

    […] By GGCRBHS&M A lack of of FDA inspections abroad may result in unsafe drugs for patients. 60% of the drugs sold on the American market are coming from foreign countries and 80% of their ingredients are also coming from abroad manufacturing facilities. As a result the FDA send inspectors abroad to make sure drugs are manufactured in a safe environment. In 2018, 57% of the FDA drug inspections occurred in foreign countries mostly China and India. Since 2016 the number of inspections has been declining because the FDA hasn’t been able to find qualified investigators or hasn’t dedicated enough time to look for them. Additionally, investigations in India and China have been found particularly challenging with the FDA being unable to conduct unannounced inspections. Announced inspections give time to manufacturers to clean the facilities or “rearrange” their papers to pass the inspection. In some cases even though the inspection was announced, inspectors found significant problems mostly related to equipment flaws and cleaning problems. Such problems can lead to cross-contamination between drug products or to alteration of the drug products.  In 2008, 81 people died and 785 suffered severe injuries after using a tainted batch of Heparin, a blood thinner, coming from a Chinese factory that had never been inspected. Additionally, according to a recent article in Fair Warning, the FDA has a history of softening its own negative inspection findings and downgrading sanctions against pharmaceuticals. This raises the concern that the FDA is after all not that concerned as to what is going on in pharmaceutical manufacturing facilities abroad. Read the entire article in Fair Warning […]

  3. Carr

    I had used some generic brand that I don’t remember many years ago of Metatropal for heart palpitations with no side effects,and last year my nurse practitioner prescribed it to help lower my recently diagnosed high blood pressure,and I felt sick as soon as I took it,and I took it for days hoping my body would get used to it and adjust to it,but it didn’t!

    Then I asked for a different generic and I felt 100 times better, but it wasn’t lowering my blood pressure that much so the nurse practitioner prescribed 50mg of Losartan with 12.5 HCTZ, but this wasn’t lowering my blood pressure enough,and I tried 100 mg but it was too strong and upset my stomach and made feel sick,so I asked the nurse practitioner to prescribe 25 mg of Losartan without the diuretic, in addition and that only lowered it a little more.

    And my pharmacy first had given me the generic brand Alembic for the 50 mg of Losartan,which was a softer different shaped pill,and I can’t swallow pills,and this pill doesn’t have a line that I can cut with my pill cutter, so I have to wet it with a drink and bite it into two pieces,and then my pharmacy switched to another brand, I don’t what it is because they just have the abbreviation of the name,but it’s a much harder pill so it’s harder to bite it, I have to wet it longer in my mouth,and the pharmacy says they can’t get the other brand anymore.

    I had hardly slept at all in several months after being diagnosed with high blood pressure and the medications not lowering it enough, I was terrified that I was going to have a stroke or heart attack in my sleep. Finally the doctor who works in the same home MD practice came and met with me only once in February 2019 and he prescribed 25 mg of a beta blocker,Atenolol in addition to both Losartan medicines, and at first after taking it for a little while it reduced my blood pressure down to normal where it used to be not that long before when I had normal blood pressure without any medicine.

    I had no bad side effects taking this,until my pharmacy switched to another generic which made me sick,so I asked them to please get the first brand and they did and they even told me this is the brand they usually get.

    My blood pressure has gone up a little though since I had first started taking it.Just very recently after I had been taking the 25 mg of Losartan of the brand Aurobindo for 3 months which was a light green pill,my pharmacy had switched generics to a white pill that made me feel sick as soon as I took it,but I took it several days alternating with the other brand that I had about 2 weeks worth left of,hoping my body would adjust to it,but this never happens.

    It turns out that this is the same brand of Losartan,the Indian company Camber including 25 mg,with the same exact NDC number,and including a 90 day supply,that the FDA recalled just months before in February 2019 for having a cancer causing ingredient NMBA!

    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-losartan-potassium-tablets-usp-25-mg

    Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API) | FDA

    This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient …

    http://www.fda.gov

    So I called the pharmacy and told them about this and asked if they could please get the other brand back,and they said to call back in a few days after the pharmacist I spoke with said she would ask the woman who is in charge of ordering the medicines,and when I called days later she told me that they can’t get this brand anymore and suggested I call other pharmacies and see if they have it and they would transfer my prescription over to them.

    So I called CVS who I used to go to for years and who are only about a walking block away,and they do carry this generic,so I had to call my nurse practitioner and get a new prescription since it was already recently filled for a 90 day supply.But my insurance company said it was too soon to refill it,and they did this for me before when I had a situation like this,so I called my nurse practitioner and asked her to please call my insurance company and explain the situation and get an override for the new prescription,but she actually refused and said it’s my responsibility to call,and that’s not really true,most of the time the insurance company needs to have the doctor call about this.

    And this is even after the nurse practitioner had just been at my house days before checking my blood pressure,and she told me the same thing she told me before when I felt sick on the other generics,that she believes me because one of her patients was taking the same pain medication for years that was helping her with her pain,and then the pharmacy switched to a different generic and it did nothing for her pain.

    And just recently before she said I should tell the pharmacists that they should make a note of what generic brands make me sick,and I said I already did this,and she said big pharmacies don’t really care about this,private pharmacies care more.I even had told her that CVS and my insurance company said they can’t fill the new prescription with the other generic until November 5,and this was October 1, so she actually expected me to take a generic medicine for a month and 5 days that was making me feel sick,and it’s a necessary medicine that I have to take to lower my blood pressure!

    So I called CVS back and I asked them how much it would cost to pay for this prescription,and the woman I spoke to said a 90 day supply would cost a 100$ which I can’t afford,so she said do you want me to check a 30 day supply,so I said yes,she told me it would be 44$ so I asked isn’t there any discount? And she checked something with a card,and found me in their system from years ago,and said yes,there is and a month supply is 11.88 so I had to buy it out of my own pocket which is really wrong.

    My nurse practitioner had called my insurance company many months before and said she was on the phone with them almost 3 hours to get the brand name of Benicar for blood pressure because my father has been taking it for 20 years and it really lowered his blood pressure,but unfortunately it caused my IBS to act up bad and I had to go back on the Losartan,this was before the doctor had prescribed the Atenolol in addition to the Losartan medicines.

    I recently asked my pharmacy to get a different generic of Xanax because it was making me feel not well,and they did get a different brand but I only felt a little bit better, I never had a problem with other generics of it from different pharmacies in the past.Also I have IBS for 26 years now off and on with bad pain,which goes away for 4 or 5 months,but unfortunately comes back,and that’s the only symptom I ever got from it,well a GI doctor prescribed the only medicine that finally took my pain away, it was the Mylan brand of Bentyl which I took for years,and then when pharmacies switched generics I tried 3 others including a liquid and none of them took the pain away like the Mylan brand did,and I used to open up the little capsule and mix it in sugar free flavored water because I can’t swallow pills,( although recently I have been able to swallow the little capsule) and only the Mylan brand dissolved in the water.

    But the Mylan brand has been on back order for the Bentyl for so long,first they told me in January of this year they were going to have it by February,then I call in February and they now claimed they were going to get it in September,so I forgot about them and luckily I tried a new brand that also really helps with the pain,and I really hope that my pharmacy continues to get it in,they said they usually get that brand.

    Some pharmacists I have spoken with act as if they don’t know or understand that it’s a reality and fact that different inactive ingredients do have different side effects on many people,and or are not effective,but I had spoken to several pharmacists in the past who did say they know that certain fillers and inactive ingredients in different generics can do this.

    It’s really wrong and terrible that pharmacies can and do, do this to patients! I’m no longer seeing this nurse practitioner and I need a primary care doctor now.

    How Differences Among Generics Might Effect Your Patient’s Response by psychiatry and pharmacy professor Vicki L Ellingrod University Of Michigan

    https://mdedge-files-live.s3.us-east-2.amazonaws.com/files/s3fs-public/Document/September-2017/0905CP_SavvyPsych.pdf

    https://www.drugs.com/answers/different-manufacturer-generic-drugs-different-3293748.html

    Can different manufacturers of same generic drugs have different side effects?
    Absolutely!! It’s difficult to find information confirming this, on line, but I can speak from personal experience in saying that with some medications I have noticed differences in efficacy and side effects when I have had to change to a different pharmacy that uses a different manufacturer for their generics.
    http://www.drugs.com

    https://www.quora.com/How-can-the-same-prescription-drug-made-by-different-manufacturers-cause-different-side-effects

    How can the same prescription drug made by different manufacturers cause different side effects? – Quora
    While the active ingredient remains the same, different manufacturers use different inactive ingredients as the binders and fillers. Different manufacturers may also use different colorings and coatings, all which could cause different side effect…

    https://www.google.com/search?q=Can+Different+Manufacturers+of+The+same+Generic+Drugs+have+different+side+effects%3F&rlz=1C1SQJL_enUS849US849&sxsrf=ACYBGNRd1q764yVSfL9od2_EWx5Z3VMNeA:1576094925318&ei=zUzxXZT3Esi3ggfn67TYDg&start=0&sa=N&ved=2ahUKEwjUkZ-Rs67mAhXIm-AKHec1Des4ChDy0wN6BAgLEC0&biw=1139&bih=577

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