Loading...

Follow Drug Injury Watch on Feedspot

Continue with Google
Continue with Facebook
or

Valid
UK Drug Safety Regulator MHRA Imposes Lemtrada Use Restrictions And Mandates Patient Monitoring For Side Effects

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In May 2019 the UK's Medicines and Healthcare products Regulatory Agency (MHRA) took regulatory action regarding Lemtrada establishing new use restrictions and requiring increased monitoring of patients using this multiple sclerosis (MS) drug.

From the introductory part of this May 17, 2019 MHRA Drug Safety Update, "Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements",
we get this summary:

While an urgent [European Union (EU)] safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function before and during treatment. All patients on alemtuzumab for multiple sclerosis should be alerted to these risks and what to do if symptoms occur.

For some background on the EU safety review of Lemtrada mentioned above, we refer you to our April 2019 article "Lemtrada Review By European Drug Regulatory Agency Covers Various Serious Side Effects In MS Patients".

Returning to the May 2019 Lemtrada Drug Safety Update from the UK's MHRA, we have compiled this list of serious side effects which have been reported in MS patients using Lemtrada "particularly within 3 days of dosing":


Cases of cardiovascular reactions

  • Pulmonary hemorrhage
  • Myocardial infarction
  • Arterial dissection
  • Stroke (hemorrhagic and ischemic)


Cases of immune-mediated disorders

  • Autoimmune hepatitis
  • Hemophagocytic lymphohistiocytosis


We will continue to watch for reports of serious cardiovascular events and immune-mediated reactions involving Lemtrada.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
Serious Cases Of Hepatic Injury Some Of Which Have Resulted In Liver Transplant Or Death Reported As Side Effects

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 21, 2019 we posted this article, "Risk Of Actemra Associated Liver Injury Being Assessed By Health Canada, With Drug Label Change Likely To Follow", which ended with this sentence:  "We will watch to see whether the FDA issues a similar drug safety warning about Actemra-related liver injury and mandates a drug label change here in the US."

Now, about three weeks later, we have our answer as regards an Actemra label change which adds warnings about the increased risk of liver injury.

The FDA sent an email on June 13, 2019 about Drug Safety-related Labeling Changes (SrLC) which alerted us to a revised version of the Actemra Prescribing Information document used in the US. Upon review of this new section added to the "Warnings and Precautions" part of the June 2019 Actemra drug label (accessed 6/13/19):

5.3 Hepatotoxicity

Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous ACTEMRA. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation with [Actemra (tocilizumab)]. While most cases presented with marked elevations of transaminases (> 5 times ULN), some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases….

Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. In this clinical context, if the patient is found to have abnormal liver tests (e.g., ALT greater than three times the upper limit of the reference range, serum total bilirubin greater than two times the upper limit of the reference range), ACTEMRA treatment should be interrupted and investigation done to establish the probable cause. ACTEMRA should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.


__________________________________________________________________

Actemra Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

Here are a couple of other earlier Actemra articles we posted on Drug Injury Watch:

We are currently investigating cases of these Actemra side effects as possible drug injury lawsuits against Genentech, Inc., the responsible drug company.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
Serious Cases Of Hepatic Injury Some Of Which Have Resulted In Liver Transplant Or Death Reported As Side Effects

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

On May 21, 2019 we posted this article, "Risk Of Actemra Associated Liver Injury Being Assessed By Health Canada, With Drug Label Change Likely To Follow", which ended with this sentence:  "We will watch to see whether the FDA issues a similar drug safety warning about Actemra-related liver injury and mandates a drug label change here in the US."

Now, about three weeks later, we have our answer as regards an Actemra label change which adds warnings about the increased risk of liver injury.

The FDA sent an email on June 13, 2019 about Drug Safety-related Labeling Changes (SrLC) which alerted us to a revised version of the Actemra Prescribing Information document used in the US. Upon review of this new section added to the "Warnings and Precautions" part of the June 2019 Actemra drug label (accessed 6/13/19):

5.3 Hepatotoxicity

Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous ACTEMRA. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation with [Actemra (tocilizumab)]. While most cases presented with marked elevations of transaminases (> 5 times ULN), some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases….

Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. In this clinical context, if the patient is found to have abnormal liver tests (e.g., ALT greater than three times the upper limit of the reference range, serum total bilirubin greater than two times the upper limit of the reference range), ACTEMRA treatment should be interrupted and investigation done to establish the probable cause. ACTEMRA should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.

Here are a couple of other earlier Actemra articles we posted on Drug Injury Watch:

We are currently investigating cases of these Actemra side effects as possible drug injury lawsuits against Genentech, Inc., the responsible drug company.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
Serious Side Effects For Xeljanz 10 mg Dose Found In Pfizer Post-Marketing Study Leads To New European Drug Safety Regulatory Action

(Posted by Tom Lamb at DrugInjuryWatch.com)

The serious side effects associated with Xeljanz related blood clots first came to our attention in February 2019, at which time we wrote this earlier article, "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism".

Less than a week later this February 25, 2019 FDA Drug Safety Communication was issued "Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate".

Then last month, in May 2019, there was more drug safety regulatory action, this time from Europe, as reported in this news report, "EMA Puts Temporary Restrictions on Tofacitinib Due to PE Risk":

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) is temporarily advising physicians not to prescribe the 10-mg twice-daily dose of tofacitinib (Xeljanz, Pfizer) to patients at high risk for pulmonary embolism (PE).

These include patients with heart failure, cancer, inherited coagulation disorders, a history of venous thromboembolism, either deep venous thrombosis (DVT) or PE, as well as patients taking combined hormonal contraceptives or hormone replacement therapy or who are scheduled to have major surgery.

Prescribers should also consider other factors that may increase the risk for PE, including age, obesity, smoking, or immobilization, the EMA said in a news release.

In addition, there is this Drug Safety Update article issued by the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), "Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing".


__________________________________________________________________

Xel­janz Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

A good summary of the practical effect of the action taken in Europe is presented by this news report, "EU regulators slap safety restriction on Pfizer’s Xeljanz":

European safety regulators have placed restrictions on Pfizer’s Xeljanz, saying it should not be used in the higher dose in patients with ulcerative colitis because of concerns of increased risk of blood clots on the lung and increased mortality.

Xeljanz (tofacitinib) is approved at the higher dose of 10 mg twice daily in patients with ulcerative colitis, although this can be reduced to 5 mg twice daily in patients who respond well.

The decision means that as the 10 mg twice daily is the starting dose for all patients, no new patients should be started on the drug in ulcerative colitis....

Xeljanz is not approved in rheumatoid arthritis in Europe at the higher dose, but is available in that dose in the US, and Pfizer’s data came from a cardiovascular post-marketing safety study required by the FDA as a condition of its licence.

We point out that Xeljanz is also approved as a treatment for psoriatic arthritis that calls for a twice daily Xeljanz 5 mg dose, which is not affected by the present drug safety concerns for Xeljanz.

We will continue to monitor developments with respect to the drug safety profile of Xeljanz in the US and Europe.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
Drug-Induced Liver Injuries Reported In Patients Using Actemra, Including Cases Of Acute Liver Failure Requiring A Transplant

(Posted by Tom Lamb at DrugInjuryWatch.com)

In May 2019 we learned that Actemra has been associated with drug-induced liver injuries, which can be serious, life-threatening, or even fatal. This is according the Canadian drug regulatory agency, Health Canada, which issued this Dear Healthcare Professional Letter, "Important Safety Information on ACTEMRA® (tocilizumab) - Risk of Hepatotoxicity", on May 21, 2019.

From this Health Canada document we get the following:

ACTEMRA is known to cause transient or intermittent mild to moderate elevation of hepatic transaminases. This risk is increased when ACTEMRA is used in combination with potentially hepatotoxic drugs (e.g., methotrexate).

Following Health Canada’s request, [Hoffmann-La Roche Limited] performed a cumulative, comprehensive assessment of serious hepatic injury including hepatic failure reported with ACTEMRA across all available clinical and post-marketing data sources, including data from the Food and Drug Administration Adverse Event Reporting System (FAERS) and Eudravigilance (EV) databases and from the literature. Eight cases of ACTEMRA-related moderate to severe [drug-induced liver injury (DILI)] were identified. These events occurred between 2 weeks to more than 5 years after initiation of tocilizumab with median latency of 98 days. Two of these 8 cases required liver transplantation. The total world-wide ACTEMRA exposure is estimated to be 1,066,849 patients (corresponding to 882,370.3 Patient Years) up to April 10, 2018.


__________________________________________________________________

Actemra Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

As background, Actemra is a prescription medicine used to treat:

  • adults with moderate to severe rheumatoid arthritis;
  • adults with giant cell arteritis, an inflammation in the arteries, especially the ones in the temples; and,
  • children older than 2 years with certain types of arthritis.

We have written about Actemra safety issues twice previously:

  1.   "Actemra Side Effects: Pulmonary Hypertension, Interstitial Lung Disease, Pulmonary Alveolar Proteinosis" (August 2018)
  2.   "Despite The High Number Of Actemra - Pancreatitis Cases Reported To FDA, No Warning Added To Drug Label" (June 2017)

We will watch to see whether the FDA issues a similar drug safety warning about Actemra-related liver injury and mandates a drug label change here in the US.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
Serious Infection In The Genital Area Seems to Be A Drug Class Side Effect Of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

A new FDA analysis article published in May 2019 provides more evidence that a class of diabetes drugs which includes Invokana, Jardiance, and Farxiga can cause a serious infection in the genital area known as Fournier’s gangrene.

As we reported in this September 2018 article, “Newer Diabetes Drugs Side Effect: Fournier’s Gangrene, Serious Infection Of Genital Area”, the FDA had previously mandated a drug-class label change with new warnings about this adverse drug reaction, which is also known as necrotizing fasciitis of the perineum.

From the Abstract for “Fournier Gangrene Associated With Sodium–Glucose Cotransporter-2 Inhibitors: A Review of Spontaneous Postmarketing Cases”, published in May 2019 by the medical journal Annals of Internal Medicine, we get these details:

The FDA identified 55 unique cases of [Fournier gangrene (FG)] in patients receiving SGLT2 inhibitors between 1 March 2013 and 31 January 2019. The patients ranged in age from 33 to 87 years; 39 were men, and 16 were women. Time to onset after initiation of SGLT2-inhibitor therapy ranged from 5 days to 49 months. All patients had surgical debridement and were severely ill. Reported complications included diabetic ketoacidosis (n = 8), sepsis or septic shock (n = 9), and acute kidney injury (n = 4). Eight patients had fecal diversion surgery, 2 patients developed necrotizing fasciitis of a lower extremity that required amputation, and 1 patient required a lower-extremity bypass procedure because of gangrenous toes. Three patients died.

____________________________________________


Invokana / Farxiga / Jardiance Free Case Evaluation

Strictly Confidential, No Obligation.


____________________________________________

 

Among the Fournier’s gangrene cases identified in this article, 21 cases were associated with Invokana (canagliflozin), 18 cases were associated with  Jardiance (empagliflozin), and 16 cases were associated with Farxiga (dapagliflozin).

Lead author Susan Bersoff-Matcha, MD, of the FDA's Center for Drug Evaluation and Research in Silver Spring, Maryland, and her colleagues emphasized that clinicians should carefully watch patients on SGLT2 inhibitors for signs of Fournier’s gangrene.  Further, they pointed out in their article: "Serious complications and death are likely if [Fournier gangrene (FG)] is not recognized immediately and surgical intervention is not carried out within the first few hours of diagnosis."

In summary, the FDA had previously added a warning about the increased risk of developing Fournier’s gangrene, also known as necrotizing fasciitis of the perineum, to the drug labels for all SGLT2 inhibitors in August 2018, based on 12 cases reported from March 2013 to May 2018.  This new FDA analysis article presents findings from a review of 55 cases reported to the FDA Adverse Event Reporting System (FAERS) through January 2019.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
February 2019 Uloric Label Changes Include New "Black-Box Warning" To The Effect That Uloric Is Gout Drug Of Last Resort

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

As a result of recent FDA-mandated label changes for Uloric there have been lawsuits filed against Takeda Pharmaceuticals America, Inc., the manufacturer of Uloric. Those drug injury lawsuits allege that the drug company Takeda failed to warn Uloric users about the increased risks of heart attacks and strokes.

Uloric (febuxostat) tablets have been generally prescribed for the management of chronic gout since 2009.

In March 2019 we posted this article, "Uloric 'Black-Box Warning' For Increased Risks Of Heart-Related Deaths And Cardiovascular Side Effects".

This previous article explained that while there was no Uloric recall ordered, in February 2019 the FDA required its strongest safety warning, i.e., Bolded Warning or Black-Box Warning, for the Uloric drug label to inform about the increased risk of heart-related death and death from all causes with Uloric.


__________________________________________________________________

Uloric Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

In addition to this new Black-Box Warning for Uloric, the FDA required Takeda to make the following label changes:

  1. Modify the "Indications and Usage" part of their Uloric drug label; and,
  2. Add a new section (5.1) titled "Cardiovascular Death" to the "Warnings and Precautions" part of their Uloric drug label, which includes this language:
    Physicians and patients should remain alert for the development of adverse [cardiovascular (CV)] event signs and symptoms. Patients should be informed about the symptoms of serious [cardiovascular (CV)] events and the steps to take if they occur.

For more background on this relatively new Uloric drug injury litigation, you can read our earlier articles about Uloric:

Our law firm is investigating possible Uloric cases involving patients who have suffered cardiovascular problems while taking Uloric. If we can be of assistance to you or someone else as regards a personal injury or wrongful death Uloric lawsuit, you can submit an online Case Evaluation Form or call us toll-free: 800-426-9535.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
EMA Will Investigate Reports Of Associated Conditions Beyond Those That Were In November 2018 FDA Drug Safety Communication

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

We recently learned by means of this April 12, 2019 European Medicines Agency (EMA) press release, "Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing", that the multiple sclerosis (MS) drug Lemtrada (alemtuzumab) is facing more scrutiny from drug regulators.

As background, we reported in this December 4, 2018 post, "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label", that in November 2018 an FDA Drug Safety Communication was issued and there was a Lemtrada label change, which included an increased risk of strokes warning being added to the "Black-Box Warning" for Lemtrada.

From this April 14, 2019 Medscape article, "PRAC Restricts Use of Alemtuzumab for MS Pending Ongoing Review", we get these details about the latest drug safety issues associated with Lemtrada:

New reports of serious side effects affecting the heart, blood vessels, lungs, and liver of patients with relapsing-remitting multiple sclerosis (MS) who are taking [Lemtrada (alemtuzumab)] have prompted the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to launch a review and to place temporary restrictions on use of the drug while the review is ongoing.

In addition to the restrictions, PRAC has recommended an update of the product information for [Lemtrada (alemtuzumab)] to inform patients and healthcare providers about cases of immune-mediated conditions, including autoimmune hepatitis and hemophagocytic lymphohistiocytosis; problems with the heart and blood vessels that occur within 1 to 3 days of treatment, including bleeding in the lungs, heart attack, stroke, and cervicocephalic arterial dissection; and severe neutropenia.


__________________________________________________________________

Lemtrada Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

Returning to the April 2019 EMA press release about their Lemtrada safety investigation, we get the following from the "Information for patients" section:

  • New cases of side effects have been reported with Lemtrada, including some affecting the heart, blood vessels, lungs and liver.
  • You should get medical help immediately if you experience symptoms of:

-- acute (sudden) heart problems (usually within 1–3 days of receiving the medicine): such as trouble breathing and chest pain
-- bleeding in lungs: such as trouble breathing and coughing up blood
-- stroke and tears in blood vessels supplying the brain: such as drooping of the face, sudden severe headache, weakness on one side, difficulty with speech or neck pain
-- liver problems: such as yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
-- an inflammatory condition known as haemophagocytic lymphohistiocytosis: such as fever, swollen glands, bruising and skin rash.

Looking forward, the PRAC’s final recommendations about Lemtrada will be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for their consideration.

We will continue to monitor drug regulatory actions regarding Lemtrada in the US, Europe, and elsewhere.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
Concerns About Potential Cardiovascular Safety Signal As Well As Suicidal Ideation And Behavior Were Involved With Zelnorm Recall

(Posted by Tom Lamb at DrugInjuryWatch.com)

In October 2018 we wrote this article, “Waiting To See Whether FDA Approves Zelnorm In 2018 After Zelnorm Was Withdrawn In 2007 For Safety Reasons”, in which we asked this question:  Despite a possible benefit to some limited patient population, is allowing Zelnorm back on the market really warranted in view of the serious and still-lingering drug safety concerns?

While we had to wait until April 2019 to get the answer, it turned out our FDA thinks the answer should be “Yes”, and so it is.

For some details about Zelnorm being allowed back on the US market 12 years after there was an FDA-mandated Zelnorm recall, we turn to this April 2, 2019 Medscape article, “FDA OKs Reintroduction of Tegaserod (Zelnorm) for IBS-C in Women Under 65”.

[Zelnorm (tegaserod)] for [irritable bowel syndrome with constipation (IBS-C)] has had a checkered past. The drug was first approved by the FDA in 2002 for the short-term treatment of women with IBS-C. It was suspended from the US market in March 2007 due to potential cardiovascular (CV) safety concerns.

In July 2007, the FDA announced that it would allow restricted use of the drug for IBS-C and chronic idiopathic constipation in women younger than 55 years with no history of heart problems.

Last October, following a safety review, the FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) recommended overwhelmingly (11 yes, 1 no) to recommend reintroducing tegaserod for IBS-C in women without a history of CV ischemic disease and who have no more than one risk factor for CV disease.


__________________________________________________________________

Zelnorm Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

From this April 3, 2019 Healio article, "FDA approves reintroduction of Zelnorm for IBS-C in certain women", we get this significant point:

Sloan Pharmaceuticals [(the responsible drug company)], a subsidiary of U.S. WorldMeds, acknowledged in [a press release] that there remains an increased risk for cardiac events, including myocardial infarction and stroke, when using [Zelnorm (tegaserod)].

For more background on this recent development, you can read our above-referenced October 2018 article about whether the FDA should allow Zelnorm back on the market and whether this would be a good idea as regards the matter of drug safety.


DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects
 (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Read Full Article
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 
Warning Letters Sent To Companies Mentor Worldwide And Sientra For Breast Implants Safety Monitoring Failures

(Posted by Tom Lamb at DrugInjuryWatch.com)

Albeit a bit off-topic for the general focus of this Drug Injury Watch blog, we have been monitoring and writing about Breast Implant Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL) for the past two years. Over that time period, the FDA has become more and more interested in this lymphoma cancer "side effect", if you will, as well as other breast implant safety issues. This increased concern is now culminating in a two-day meeting of medical experts to be convened next week.

Specifically, there will be an FDA CDRH General and Plastic Surgery Devices Advisory Committee Meeting held on March 25-26, 2019. As the FDA Agenda document for this meeting shows, the first day will be focused in large part on the lymphoma cancer associated with breast implants, ALCL, which is a rare type of blood cancer that is classified as a non-Hodgkin lymphoma, and one of the sub-types of T-cell lymphoma.

As is customary for FDA Advisory Committee Meetings, background materials and specific panel questions were released by the FDA prior to the March 25-26, 2019 breast implants meeting. Those items are set forth below:

From the FDA Executive Summary document, titled "Breast Implant Special Topics", we get this focal point:

Breast implants are associated with BIA-ALCL, a cancer of the immune system. While most patients with BIA-ALCL may be treated only with breast implant removal, some patients have required radiation therapy, chemotherapy or both, and some patients have died from BIA-ALCL.  [See "Introduction", at page 5]

A more detailed discussion of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) can be found at pages 13-18 of this FDA Executive Summary document.


__________________________________________________________________

Breast Implants Lymphoma / Cancer Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

Moving onto a different aspect of the breast implant safety topic, on March 19, 2019 there appeared this FDA News Release, "FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements".

This excerpt comes from the start of that March 2019 FDA document:

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

For those who want to know more, you can read one or both of the FDA warning letters to those breast implant manufacturers:

As our law firm has been actively investigating BIA-ALCL cases for women as possible lawsuits against these companies and other breast implant manufacturers, we applaud the increased scrutiny that the FDA is bringing to the breast implant safety issue.

If you want to learn more about this issue, you can start at our Breast Implants Lymphoma Cancer information page.

Read Full Article

Read for later

Articles marked as Favorite are saved for later viewing.
close
  • Show original
  • .
  • Share
  • .
  • Favorite
  • .
  • Email
  • .
  • Add Tags 

Separate tags by commas
To access this feature, please upgrade your account.
Start your free month
Free Preview