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FDA Points Security Alert Concerning Intrathecal Supply of Ache Meds

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FDA: Up to date Security Alert Concerning Benzocaine-Related Methemoglobinemia


Could 23, 2018

Since 2009, 119 cases of benzocaine-associated methemoglobinemia have been reported

Since 2009, 119 instances of benzocaine-associated methemoglobinemia have been reported

Over-the-counter (OTC) oral merchandise containing benzocaine shouldn’t be used to deal with kids <2 years previous as these merchandise carry important security dangers reminiscent of the potential of methemoglobinemia, in accordance with the Meals and Drug Administration (FDA). As such, the Company is urging producers to cease advertising OTC oral drug merchandise containing benzocaine for teething to this affected person inhabitants.

As well as, the FDA has requested producers of OTC benzocaine-containing oral drug merchandise to make adjustments to the labeling with regard to make use of in adults and kids over the age of two. These adjustments embrace:

  • Including a warning about methemoglobinemia
  • Including contraindications directing customers to not use the product for teething and to not use it in kids <2 years previous
  • Revising the instructions to obviously state that the product shouldn’t be utilized in kids <2 years previous

In earlier communications, the FDA had warned the general public about experiences of methemoglobinemia in people  utilizing OTC benzocaine gels and liquids in addition to benzocaine sprays for medical procedures. “Due to the shortage of efficacy for teething and the intense security considerations we have seen with over-the-counter benzocaine oral well being merchandise, the FDA is taking steps to cease use of those merchandise in younger kids and lift consciousness of the dangers related to different makes use of of benzocaine oral well being merchandise, ” mentioned FDA Commissioner Scott Gottlieb MD. “Along with our letters to corporations who make these merchandise, we urge dad and mom, caregivers and retailers who promote them to heed our warnings and never use over-the-counter merchandise containing benzocaine for teething ache.”

Associated Articles

The FDA can be requiring producers of all prescription native anesthetics to standardize warning details about the chance of methemoglobinemia in product labeling throughout this class of merchandise. Healthcare professionals who use native anesthetics are being suggested to reduce the chance of methemoglobinemia by monitoring sufferers for indicators and signs, utilizing co-oximetry when attainable, and having resuscitation gear and drugs accessible, together with methylene blue. Sufferers at elevated threat for methemoglobinemia embrace these with respiratory issues (i.e., bronchial asthma, bronchitis, emphysema, people who smoke), coronary heart illness, sufferers with sure inborn deficits (i.e., glucose-6-phosphodiesterase deficiency, hemoglobin-M illness, NADH-methemoglobin reductase [diaphorase 1] deficiency, and pyruvate-kinase deficiency), and the aged. 

If lidocaine is used, healthcare workers needs to be acquainted with applicable dosing, correct administration methods, and security monitoring; benzocaine sprays will not be FDA-approved to numb mucous membranes of the mouth and throat or to suppress the gag reflex throughout medical procedures. A examine evaluating the relative capacity of benzocaine and lidocaine to make methemoglobin confirmed that benzocaine generated far more methemoglobin than lidocaine in a crimson blood cell mannequin.

With regard to OTC merchandise, clinicians ought to instruct sufferers trying to make use of benzocaine-containing merchandise to use solely a small quantity and to not use the product greater than four instances per day; indicators and signs of methemoglobinemia might seem inside minutes to 1–2 hours after use. Drugs, meals, and water containing nitrites and nitrates can also induce methemoglobin formation which may be additive to that fashioned with benzocaine merchandise. 

Since 2009, 119 instances of benzocaine-associated methemoglobinemia have been reported to the FDA, four of which had been deadly. The Company will proceed to observe the security of benzocaine-containing merchandise and can take additional motion if essential. Within the meantime, hostile occasions associated to benzocaine and prescription native anesthetics needs to be reported to the FDA MedWatch program.

For extra data go to FDA.gov.

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Supreme Court arguments regarding action that consumers listen to the damage allegedly caused by the generic drugs Sue could tell Parker Waichman LLP


19th (PRWEB) March 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of injured victims of defective drugs, is commenting on the latest developments in Bartlett v. Mutual Pharmaceutical Company, U.S. Supreme Court, No. 12-142, An action in which the plaintiff alleged violations of sulindac, a generic version of the steroidal anti-inflammatory drugs (NSAIDs), Clinoril. According to a Reuters report on 18 Was published in March 2013, Mutual Pharmaceutical Co. has asked the High Court, given a $ 21 million judgment plaintiff Karen Bartlett, who caused crash trying sulindac claiming a severe form of Stevens-Johnson syndrome. The Supreme Court was to hear arguments in the case yesterday, Reuters reported.


At its difficult for the consumer to sue over alleged violations of generic, Matthew J. McCauley, Senior Litigation Counsel says Parker Waichman LLP. Help decide the outcome of this case future litigation over generic medications. The national injury law firm offers free legal advice to patients allegedly injured defective drugs and medical devices.

According to Reuters

Mutual Pharmaceutical Co. has asked the Supreme Court to overturn the $ 21 million to plaintiffs Karen Bartlett on their generic drugs sulindac. Bartlett claimed sued the company in 2008 that the NSAID medication. Severe form of Stevens-Johnson syndrome, a rare hypersensitivity reaction, which allegedly caused her skin to peel off, causing burn-like lesions over two-thirds of her body Reuters reports that about it for almost two months in a hospital burn unit and has 13 eye surgeries, allegedly because sulindac. Their lawsuit alleges that the reaction left her nearly blind. With scarred lungs and a narrowed esophagus, which makes it hard to swallow The jury awarded them with $ 21 million after two-week trial.

Reuters reports that Mutual tried to overturn the award, arguing that federal law prevents lawsuits like Bartletts, because the manufacturers of generic drugs are required to wear the same design and label as their brand-name counterparts. Bartlett’s claim circumvented this restriction by claiming that sulindac itself was inherently dangerous and defective. Mutual cited the case of PLIVA, Inc. v. MENSING (Nos.09-993, 09-1039 and 09-1501), which means that generic drugmakers could not be held liable for alleged violations are excluded because they are not responsible for what is drugs on the safety label, the company claims that this logic to the design of the product and applies. However, Mai decided unanimously three judges of the first Circuit Court of Appeals in Boston, that the scheme is not to assert claims design defects. Mutual has stopped production and sale of the drug, have the court ruled. Reuters reports that the U.S. Food and Drug Administration (FDA) received reports of adverse skin reactions associated with sulindac.

can be crucial

outcome of the proceedings to determine whether generic makers are liable for alleged violations by their drugs, according to Reuters. About 80 percent of prescriptions are filled in the U.S. generic. Even if a doctor prescribed a brand name drug, state laws allow pharmacists automatically replace it with a generic. It is much harder for consumers to sue for generics makers if the court finds that state requirements are superseded by federal law.

Parker Waichman LLP is a leading mass tort, environmental damage and personal injury law firm that represents plaintiffs in personal injury lawsuits nationwide. The company has offices in New York, Long Iceland, New Jersey, Washington, DC and Florida. For more than two decades, Parker Waichman LLP has assisted thousands of clients in a fair compensation from the negligence of others. For more information on Parker Waichman LLP, please visit:. Http :/ / www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636)

Parker Waichman LLP

Gary Falkowitz, Managing Attorney??

(800) LAW-INFO

(800) 529-4636


Has a new lawsuit by users lipitor regarding missing information to users was filed about the side effects?


Has filed a new lawsuit by users lipitor regarding missing information to users about the side effects?
Last week, on the evening news, there was new information about the side effects of Lipitor … Memory loss, spikes in blood sugar and possible liver damage. These side effects, and never mentioned before anywhere, not on the label, physician, etc. Best Answer (s):

response by Betsy
Apparently more. This is a link to information about some of the complaints: http://www.krumlaw.com/press.htmlSie are not necessarily new. Most of the lawsuits involve memory loss. You could probably get more information by the law firm.

I have a question regarding the medication Lisinopril?


I have a question regarding the medication Lisinopril?
I have been taking Lisinopril for my b/p. It has been a week now. I have two questions. Has anyone taking this medication had frequent urination? Also do you know why they tell you to not take potassium? Thank you

Best answer(s):

Answer by John de Witt
I can’t imagine why it would cause increased urination to a notable degree, unless you have one of the combination pills that also contains hydrochlorthiazide.
You should only take potassium supplements under the direction and close supervision of a physician because it tends to cause potassium retention. While other blood pressure medications can cause your potassium to go abnormally low, and a low potassium level can make you feel tired and achy, this one (when taken with potassium supplements) can cause your potassium level to go abnormaly high. The minor side effect that may be your first sign of high potassium is dropping dead suddenly, and that’s generally considered bad form in medical circles.