Tag: FDA

Florida drug manufacturer closes facility following lawsuits and FDA warnings

~ susie

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A Davie, Florida pharmaceutical manufacturer closed its manufacturing facility after the filing of two lawsuits related to defective products manufactured at the location, as well as numerous FDA violations following an inspection of the facility in 2017.

PharmaTech, LLC vacated its Davie plant after the FDA cited it for numerous safety, quality, and procedural violations during an inspection that began in March 2017. Prior to those violations, PharmaTech was named in two separate lawsuits, one of which involved the death of an infant in Pennsylvania and the other that involved serious personal injury to an individual who took some of its medications.

The infant, Alivia Singleton, died after she was given “Diocto Liquid”, a stool softener manufactured by PharmaTech. Alivia was in the hospital for a respiratory issue and the medicine was found to contain a rare complex of bacteria that posed significant risks to individuals suffering from chronic respiratory issues. Following this, an outbreak related to this bacteria being found in other liquid PharmaTech products resulted in a voluntary recall of Diocto Liquid, which was later expanded to all liquid PharmaTech products.  

The second lawsuit was filed by Virginia Allgood, who alleges that she suffered serious personal injury from dizziness, tremors, and seizures that resulted from her taking Hyoscyamine Sulfate which is often used to treat the symptoms of IBS that had been prescribed to her in 2016.  She continued taking the drug until she was notified by mail of a recall of the product. Testing found the medications contained both subpotent and superpotent mixtures of the drug.

In October 2017, the FDA issued a warning to all doctors and individuals to avoid any liquid medication produced by PharmaTech and to pay attention because these drugs are often distributed under different labels.  

“Situations such as these remind everyone of how much faith we put into the manufacturers of the medications we rely on for our health to produce them safely and correctly,” said Gordon J. Glover, a Marion County personal injury attorney with Glover Law Firm. “Consumers rely fully on the pharmaceutical company to take its production and quality control requirements seriously – in many cases putting their very lives in the hands of these companies. Unfortunately, PharmaCare’s negligence led to dozens of serious injury and the death of a little girl.  PharmaCare has to be held accountable for its actions, and the FDA’s recalls are just the first step.”

If you used one of PharmaCare’s drugs and suffered an adverse reaction, follow this link to file a report with the FDA to ensure that the proper authorities are aware.

We’ve seen this movie before

~ susie ~ 1 Comment

Kratom

The FDA is trying to put kratom, a Southeast Asian plant, on Schedule 1, like heroin — just like they did with marijuana so long ago.

Here’s an interesting article from Rolling Stone. I strongly suggest you read it, because you’ll hear a lot of misleading information as the FDA gears up.

Read this typical post from the American Council on Science and Health, a pro-industry group that is famous for things like pushing formula over breast milk, for the kind of thing we can expect.

I’ve been using kratom for about a month for my knees. (My doctor offered me oxycontin; I said no thanks.) It also makes it possible for me to write without severe carpal tunnel pain — and my teeth don’t hurt.

And here’s the thing: Many, many people use kratom to get off heroin and other opioids. They say the withdrawal is mild, like quitting coffee. (It also helps people stop drinking.) But Big Pharma is gearing up to make a killing (ha ha!) on their own drugs, made especially to get people off their other drugs.

It would be just my luck to discover something really helpful right before they outlaw it.

https://twitter.com/KratomNurse/status/978384547476791296\

And yes, I know about salmonella and e.coli. Reputable distributors test their supply. I’d be more worried about a McDonald’s burger.

FDA: Breast implants can cause rare type of cancer

~ susie

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The Food and Drug Administration (FDA) recently announced that breast implants can cause a rare form of cancer. The agency is currently reviewing more than 350 reports it has received that link both saline and silicone breast implants with anaplastic large cell lymphoma (ALCL), a non-Hodgkin’s lymphoma. The FDA reports that there have already been nine deaths linked to the breast implants.

According to national statistics, breast implants is the second most popular cosmetic surgery. Liposuction is number one. There are more than 300,000 procedures performed each year.

In 2011, the FDA concluded that half of all women who get implants after a mastectomy and 20 percent of women who get implants for cosmetic reasons need to have the implants removed within 10 years.

It was also the same year that the FDA began receiving reports about the possible link between ALCL and breast implants. As the agency was investigating the increasing number of reports being filed, the World Health Organization (WHO) also began to study the possible link. WHO has confirmed that breast implants cause ALCL in a recently published report.

According to both the FDA and the WHO report, it can take approximately 10 years after an implant procedure for the cancer to begin developing. Typically, the cancer stays in the area of the implant, but it can break out and metastasize.

The FDA reports that there appears to be more of risk of developing the cancer for women who received textured implants compared to smooth implants. The first indication there may be an issue is if pain and swelling develops. Treatment involves removing the implants and following up with radiation and chemotherapy.

Upon hearing of the FDA announcement, Attorney Boyk commented, “There have been so many medical issues over the past several years for women who have had implants, including cancers and autoimmune diseases. Any woman who is considering this surgery really needs to do through research and find out all the risks truly involved. Anyone who has had issues with breast implants, or any other type of medical device, should seek medical treatment right away.”