Pharmaguy's Insights Into Drug Industry News
187.2K views | +14 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys

Another Reason for Seniors to Skip Zostavax Vaccine for Shingles: Serious Side Effects Claim Attorneys | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck & Co. could have a growing Zostavax problem on its hands. After several plaintiffs filed lawsuits claiming the drugmaker’s shingles vaccine caused serious injury and death, attorneys say more cases are on the way.

 

Plaintiffs have sued in state and federal courts in Pennsylvania alleging that Merck’s Zostavax—used to prevent shingles, the painful complication of varicella infection—caused serious side effects, including death.

 

“I think Merck has failed terribly … to warn about the very serious side effects and the failure of the vaccine to do what they claim it does,” attorney Marc Bern told FiercePharma.

 

Bern, founding partner at Marc J. Bern & Partners, said his firm has “thousands of complaints” yet to be filed in Philadelphia, with the injuries running “the gamut from contracting shingles as a result of the vaccine all the way to serious personal injuries such as blindness in one eye, individuals who have serious paralysis in their extremities, brain damage, all the way to death.”

 

In a statement, Merck said it “stands behind the demonstrated safety and efficacy” of the shot, which is licensed in 50 countries.

 

Further Reading:

Pharma Guy's insight:

Seniors have bee avoiding getting vaccinated for shingles even though the Affordable Care Act requires private insurers to cover Zostavax without co-pays for people older than 60 (read “Early Shortages, Delayed Marketing, High Prices, Other Health Priorities, Among Reasons Why Seniors Skip Shingles Vaccine”; http://sco.lt/4wT9NZ Perhaps the side effects mentioned in this article is a bigger reason.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA Warning: Hepatitis C Treatments Viekira Pak & Technivie May Cause Serious Liver Injury

FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.


FDA review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.


Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. Some of the cases occurred in patients for whom these medicines were contraindicated or not recommended (see the Drug Safety Communication Data Summary section). FAERS includes only reports submitted to FDA, so there are likely additional cases about which FDA is unaware.


BACKGROUND: Viekira Pak and Technivie are used to treat chronic hepatitis C. Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin, another hepatitis C medicine. Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.


RECOMMENDATION: Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.


Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines.

Pharma Guy's insight:

Oh my!

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

EU Bans Codeine Cough Medicines in Children. FDA Continues to "Evaluate Potential Risk."

AUDIENCE: Family Practice, Pediatrics, Surgery, Patient

ISSUE: FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing. 

Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids.

In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children under 12 years, and that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. 

FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete. 

BACKGROUND: Codeine is a specific type of narcotic medicine called an opioid that is used to treat mild to moderate pain and also to reduce coughing.  It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines.   

RECOMMENDATION: Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911.  Parents and caregivers should always read the product label to find out if a medicine contains codeine and talk with their child’s health care professional or a pharmacist if they have any questions or concerns.  Health care professionals should continue to follow the recommendations in the drug labels and use caution when prescribing or recommending codeine-containing cough-and-cold medicines to children.  

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA Warns About Serious Side Effects of Diabetes Drugs: Invokana & Jardiance

FDA Warns About Serious Side Effects of Diabetes Drugs: Invokana & Jardiance | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The US FDA has warned that drugs in the SGLT2 inhibitor class of diabetes therapies can cause a potentially serious side effect.


The class - which includes widely used products such as Invokana (canagliflozin) from Johnson & Johnson, Eli Lilly/Boehringer Ingelheim's Jardiance (empagliflozin) and AstraZeneca's Farxiga (canagliflozin) - has been linked to high levels of blood acids that could require hospitalisation.


The US regulator said doctors and patients should pay close attention for any signs of the condition - known as ketoacidosis - such as "difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness."

Pharma Guy's insight:


Diabetes drugs have been on the FDA's safety watch list for years, in part because they are used by such as high number of people but also on the back of a series of health scares. 


Most recently, the agency recommended changes to the labelling of two products in another diabetes drug class, the DPP4 inhibitors - after data suggested a link to cardiovascular complications. 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

How to Put Glossy Lipstick on the TV DTC Drug Ad "Pig"; i.e., Side Effect Warnings

How to Put Glossy Lipstick on the TV DTC Drug Ad "Pig"; i.e., Side Effect Warnings | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Julieta Smith, group strategy director, McCann Humancare -- part of the same healthcare agency that won a Lions Health 2014 GOLD award for Fictional Patient Story (not that that's a good thing compared to a REAL patient story that only won a BRONZE award) -- thinks that the same “generic” warning repeated in all direct-to-consumer (DTC) drug ads would be more effective than SPECIFIC warnings now required by the FDA.

In an article written for MM&M (here), Smith suggests ALL drug DTC ads on TV just end with this warning message:

“All drugs carry certain risks and should not be used by everyone. These risks can range from inconveniences to the risk of death. You should talk to your doctor to determine your specific risks, reasons you might not be a candidate to use this drug, and any side effects and warnings that may pertain to you personally before you take it. To learn more visit brandx.com.”

Pardon the phrase, but this is an example of “putting lipstick on a pig.” Maybe it's not PC, but I think that's an appropriate analogy.

Smith believes this is a solution to a major problem with TV DTC advertising. Find out here.

Pharma Guy's insight:


I think most marketers -- especially marketers of relatively “safe” drugs -- would not like the word “death” mentioned in their ads if that “side effect” is not part of the drug's FDA-approved label.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Mirapex, ReQuip, Etc. Should Have Prominent Black Box Warnings About Serious "Psychotic-like," Compulsive Behavior

Mirapex, ReQuip, Etc. Should Have Prominent Black Box Warnings About Serious "Psychotic-like," Compulsive Behavior | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For several years, a group of drugs used to treat Parkinson’s disease has been blamed for various unusual addictive behaviors, such as pathological gambling, compulsive shopping and sudden sexual urges. Sensational stories occasionally appeared in the media and lawsuits were filed by patients who blamed the drugs, such as Requip and Mirapex, for wreaking havoc on their lives.


Now, a new analysis suggests in JAMA Internal Medicine finds these widely used drugs. known as dopamine receptor agonists, are more closely associated with these impulse control disorders  than has been demonstrated. Consequently, the study authors are calling for stronger warnings – specifically, so-called Black Box warnings, which are the most serious type of warning – to be added to product labeling.


In reaching their conclusions, the researchers analyzed 2.7 million domestic and foreign side effects for all drugs reported to the FDA between 2003 and 2012. 


Using a statistical analysis they found the proportion of side effects involving impulse control behaviors was 277 times higher than other central nervous system drugs, such as those used to treat depression, schizophrenia and epilepsy. 


“The associations were significant, the magnitude of the effects was large and the effects were seen for all six” of the dopamine receptor agonists, they wrote. And they conclude by noting that none of these six drugs currently have boxed warnings about impulse control disorders, but that such warnings should be added based on their findings, as well as small studies indicating the reasons for the side effects may go unrecognized.


“This is a striking example of an unusual and very specific set of psychiatric side effects linked to drugs that effect a specific neuroreceptor,” lead author Thomas Moore, a senior scientist at the Institute for Safe Medicine Practices, a non-profit, writes us.“In some patient groups, 10% to 15% may experience this potentially catastrophic side effect, a rate of injury that is extremely high.”


The association was strongest for the dopamine agonists pramipexole [Mirapex] (n = 410; PRR = 455.9, P < .001) and ropinirole [ReQuip] (n = 188; PRR = 152.5, P < .001)

Pharma Guy's insight:


"Our findings confirm and extend the evidence that dopamine

receptor agonist drugs are associated with these specific impulse control disorders," say the authors. "At present, none of the dopamine receptor agonist drugs approved by the FDA have boxed warnings as part of their prescribing information. Our data, and data from prior studies, show the need for more prominent warnings."


The same companies that market these drugs -- e.g., GSK for ReQuip -- also want to market drugs that treat some of the side effects such as "Hypersexuality." GSK, for example, at one point wanted to market Paxil for Persistent Genital Arousal Disorder or PGAD (see story here: PGAD. EGAD! Another Syndrome/Disorder, Whatever!).


Somewhere way down in the ReQuip official FDA labeling, you'll find this:


"Postmarketing reports indicate that patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during treatment with REQUIP or after starting or increasing the dose of REQUIP. Other drugs prescribed to improve the symptoms of Parkinson’s disease can have similar effects on thinking and behavior. This abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium."


Pretty serious. This information should, IMHO, be placed in a black box instead of being hidden within the other side effects and often the LAST side effect mentioned! 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Using electronic health records to help advance drug development and safety monitoring

Using electronic health records to help advance drug development and safety monitoring | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Not long ago, electronic health records (EHRs) were an idea solely for the future. Today, they’re a reality. Paper records are becoming part of the past. These days, when patients go to their physician’s offices, they are much more likely to have their care documented electronically. EHRs give health care professionals more data to provide patients higher levels of quality care and safety.


Now that EHRs are more widely used, they collectively represent huge amounts of important data about the medical products and prescription drugs patients are using. Significant amounts of information in patient EHRs may be used in clinical research, with appropriate protection of patient privacy, to aid the development of new and more effective medical therapies or to provide information on using existing treatments more effectively and safely. These data, combined with other sources of electronic healthcare data such as information from healthcare claims, are being used to better understand the performance of medical products.


A key challenge for the research community is to effectively harness the data contained in EHRs.

Pharma Guy's insight:


It seems to me that the FDA can reverse the dramatic rise in adverse event reports it receives by approving fewer new drugs with serious side effects. Case in point: The approval of Endo Pharmaceuticals' testosterone replacement therapy drug Aveed (read more here).

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA requires more warnings on testosterone products

FDA requires more warnings on testosterone products | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.


Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014.


Testosterone products are FDA-approved for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone for reasons such as genetic problems or chemotherapy.

Pharma Guy's insight:


In February, 2014, Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. 


Read:

Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling

A pharma compliance executive -- who shall remain anonymous -- emailed me saying: "Great to know that OPDP got their [Twitter] guidance out in time to make clear that no testosterone manufacturer should be able to tweet about the new warning."


That brings up an interesting point. 


If a pharma company-- e.g., AbbVie, which markets Androgel -- wishes to tweet about this emerging risk, would the tweet be considered promotional by the FDA? For example, the tweet can mention the product name WITHOUT the indication and warn about this issue and link to more information (e.g., the FDA notice). At most, that tweet would be considered a "reminder" ad and would not be subject to the new guidelines published by OPDP.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

The Goose That Laid the Golden Egg: Based on Roche & Accutane

A psychiatrist risks all to expose a corrupt drug company.

Described as Erin Brockovich meets The Constant Gardener, THE GOOSE THAT LAID THE GOLDEN EGG is based on a true story that involves greed, power, lies, tragedy, danger, and death. It is also an inspirational and spiritual story, with themes of overcoming personal loss and personal redemption. The entirety of Psalm 46 is in the screenplay, which is written by Doug Bremner and Cathy Reinking.

Renzon Pharmaceuticals aren’t about to let a psychiatrist get in the way of their billion dollar a year miracle cure for acne. So when Dr. Johnny Forteo dares to question the potentially lethal side effect of their drug, Synoderm, they pull out the stops, ultimately leaving him jobless, friendless, wifeless – but not, completely hopeless.

Drawn into the medication controversy as an unwilling participant, he learns that he must confront the lies and deception in his own life before he can confront the lies and deceptions of others. With nothing left to lose, he goes on a journey to revisit a tragedy from his own past. Along the way he is joined by Ginny Bellaconda, the bereaved mother at the center of ongoing litigation with Renzon. When he unearths more painful secrets and deceptions that parallel those he has discovered in the pharmaceutical company, his voyage of self-discovery gives him strength to resume his struggle, now joined by Ginny, leading to the ultimate tumultuous conclusion.

From Amazon reader reviews of the well-reviewed non-fiction version of The Goose That Laid the Golden Egg:

“An indictment of the pharmaceutical industry... illuminates the greed and unscrupulous nature of pharmaceutical companies and their market driven interests.”

“A compelling and spell-binding narrative which fuses the personal and social in a heroic quest.”

“I was so fascinated (and horrified) once I started reading, I finished the book in a single day.”

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Money Doesn't Make Big Pharma Accountable: Why Suing Isn't Working

Money Doesn't Make Big Pharma Accountable: Why Suing Isn't Working | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Since early September, we've seen five major pharmaceutical companies in the news for not disclosing known risks of certain drugs. Here's snapshot of the most recent legal action pertaining to Big Pharma: 


  • Makers of antidepressant Paxil paid out $3 billion in fines for -- among other misdeeds -- illegally persuading doctors to prescribe the drug to children and teenagers despite internal evidence that it's ineffective and can trigger suicidal thoughts in adolescents.
  • Two manufacturers of low testosterone therapy, marketed as a "fountain of youth", have been sued for not disclosing increased risk of heart attacks and strokes. 
  • Makers of Actos, a diabetes drug, failed to inform consumers and medical professionals about the risk of bladder cancer associated with use -- for which they paid out $2.34 billion in settlements.
  • The manufacturer of Zoloft, an antidepressant, has been accused of ignoring internal red flags -- and not warning consumers -- about potential heart defects in newborns. 
  • And Johnson and Johnson and Bayer Corp. are being sued based on allegations that they deliberately concealed the blood thinner Xarelto's potential fatal side effect of internal bleeding. They've also been in ongoing litigation for potentially hiding known information about male breast growth resulting from the antipsychotic Risperdal


These cases aren't anomalies. In 2012, Bayer paid $110 million to settle allegations that some consumers experienced fatal blood clots when using the oral contraceptive Yasmin. In 2010, makers of diabetes drug Avandia agreed to pay $460 million to settle 10,000 lawsuits whose plaintiffs claimed the company hid its heart attack risks. In 2008, the manufacturer of the painkiller Vioxx paid out $4.85 billion to settle 50,000 claims that users suffered heart attacks and strokes. 


Yet these drugs each racked up billions in sales. The persistence of Big Pharma's fraud despite ubiquitous legal action suggests that our present efforts to hold the industry accountable are ineffective. 


Why?

Pharma Guy's insight:

Here's one scary reason why:

Because the Supreme Court doesn't hold Big Pharma liable

 

In 2013, the U.S. Supreme Court ruled that "if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions." But since research is often either funded or conducted by Big Pharma, and companies are able and willing to conceal serious side effects, the FDA can't accurately determine whether a drug is safe. 

 

The ruling furthermore made all U.S. generic drugs -- which compose 80 percent of the market -- exempt from liability for side effects.

 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Is Cymbalta Withdrawal "Zapping" Patients' Brains?

Is Cymbalta Withdrawal "Zapping" Patients' Brains? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Eli Lilly & Co. was ordered to face claims it misled consumers about “brain zaps” and other withdrawal side effects tied to its antidepressant Cymbalta in the first cases slated to be heard by juries.


Lilly’s bid to have former Cymbalta users’ lawsuits thrown out was rebuffed by a federal judge in California, who found they raised legitimate questions about the drugmaker’s warnings about withdrawal risks.


Jurors must decide whether Lilly officials designed Cymbalta studies to “under-report the risk of discontinuation symptoms,” U.S. District Judge Steven Wilson in Los Angeles ruled June 19. He set the first two trials in his court for August.


‘Brain Zaps’

The drugmaker faces more than 5,000 cases claiming it downplayed Cymbalta’s withdrawal side effects, which allegedly include electrical-shock sensations described in court filings as “brain zaps.” Other withdrawal effects are said to include nausea, vomiting and insomnia.


“We believe in our defenses to these claims and we will continue to defend Lilly vigorously,” Scott MacGregor, a Lilly spokesman, said Wednesday.


The patients contend Lilly executives downplayed the withdrawal risks on the drug’s warning label, saying only about 2 percent of users experienced side effects when coming off the medication, according to court filings.


Studies have found more than 40 percent of Cymbalta patients suffered withdrawal after quitting the medicine, the consumers said in court filings.

Pharma Guy's insight:


Lilly disclosed on warning labels in Europe that 45 percent of users reported experiencing some withdrawal symptoms after they stopped taking the drug, the patients said in court filings. Why only in Europe? What's FDA say about this?


This may be a case where side effects are more frequent in real life than in clinical trials that only last for a few weeks -- see here: http://bit.ly/1FNx67g

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

If a #Pharma Company Treated You Like a Starbuck's Barista

Experiment 1: We live in the information age, which is nice. But can we ever have too much of a good thing?
Pharma Guy's insight:


This is another example of a marketing company (GSW) belittling the "fair balance" section of TV and print DTC ads and suggesting that patients would prefer ads without those "details." For another example of this genre, read "How to Gloss Over Warnings in TV DTC Ads": http://bit.ly/1IerxEt 



Yeah, I know,,, The title should read "If a barista treated you like a pharmaceutical company" but I switched it around to get you thinking in the other direction because Rx DRUGS are NOT in the same ballpark as Latte! If you want to make spoofs like this, then you should compare Latte and over-the-counter (OTC) drugs. Of course, that's not funny because there's hardly a mention of side effects in ads for those drugs, so the spoof would be meaningless.


more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Former Lilly in Sweden Insider Talks Side Effects and Death

Former Lilly in Sweden Insider Talks Side Effects and Death | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The former managing director of drug giant Eli Lilly and Company in Sweden continues to reveal the business practices of the pharmaceutical industry, scoring a major victory in announcing that his first book, Side Effects: Death. Confessions of a Pharma-Insider, will be turned into a full-length feature film.


John Virapen, who began his career with “Big Pharma” in 1968 as a salesman knocking on doctors’ doors, rose through the ranks to realize what he was pitching were not drugs, but death. Virapen was well aware early on that thousands had died or committed suicide by taking the drugs he was pushing. “I indirectly contributed to the death of . . . people, whose shadows now haunt me,” he explained in his book.


Dave Gahary had the opportunity to sit down with Mr. Virapen to discuss how he got into bed with Big Pharma, what motivated him to write this book, and what his long-term goals are, in this informative interview (15:36).


Pharma Guy's insight:


John Virapin was first interviewed by PharmaGuy back in 2007 on this Pharma Marketing Talk show: A Former Lilly Insider Blows the Whistle on Criminal Activity in Sweden

more...
lorraine cleaver's curator insight, October 27, 2014 8:13 PM

This guy knows what we are up against. The continual polypharmacy that feeds profit yet keeps us ill. Chronic patients - the gift that keeps on giving.

Scooped by Pharma Guy
Scoop.it!

Pfizer settles all 2,900 lawsuits against its anti-smoking drug Chantix

Pfizer settles all 2,900 lawsuits against its anti-smoking drug Chantix | Pharmaguy's Insights Into Drug Industry News | Scoop.it
All of the nearly 2,900 lawsuits claiming pharmaceutical giant Pfizer Inc.'s smoking cessation drug Chantix triggered suicidal thoughts and other psychological problems in patients have been settled - for about $300 million - so the nationwide litigation should now be dismissed, a federal judge in Alabama ruled Monday.


Despite the end to those lawsuits, Pfizer next week will continue its fight with the U.S. Food and Drug Administration for a less severe warning label for Chantix.


While the lawsuits are now in the rear view mirror for Pfizer, the company is fighting to get the U.S. Food and Drug Administration to ease up on the "black box" warning on Chantix - a label added in 2009 to warn of potential serious side effects.   


The Wall Street Journal recently reported that the FDA in September updated the warnings and precautions section on Chantix to include information about some new studies that show the drug's psychological effects, including suicide, isn't as bad as once thought.


Pharma Guy's insight:


Say Pfizer wins its case against the FDA and is no longer required to include black box warnings about "new" serious side effects. That would mean that Pfizer can more aggressively market Chantix, including "reminder" ads on Twitter. However, I am sure that Pfizer sales reps will NOT be distributing reprints focusing on the "new" safety information, the rules for such distribution were recently relaxed by the FDA (read "Presenting 'New Risk Information' About Drugs to HCPs").

more...
K.I.R.M. God is Business " From Day One"'s curator insight, July 2, 4:51 AM

As a young individual, there are certain drugs that you may have been provided by doctor that now because of Class Action Lawsuits filed and won that you just may be a person due compensation per your share. 


 

Scooped by Pharma Guy
Scoop.it!

DTC Makes My Job Harder, Says Doc

DTC Makes My Job Harder, Says Doc | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Direct-to-consumer advertising is the biggest barrier to practicing medicine today, cardiologist Harmony Reynolds, MD, said in response to one of 10 questions MedPage Today is asking thought


1. What's the biggest barrier to practicing medicine today?

Direct-to-consumer advertising. These ads often frighten people about medication side effects without providing the right information about why a medication may be needed and why taking a small risk of side effects may be worthwhile. I don't think companies realize all of the effects these ads have. They make my job harder.

Pharma Guy's insight:


OK. One physician does not a consensus make. Her specialty is coronary artery disease and she seems to like prescribing high doses of statins. Ads for statins actually mention why they are needed and they don't overplay the risks, which are minimal.  So I am not sure why these DTC ads would be a barrier to Dr. Reynolds' practice of medicine.


In any case, drugs ads tend to understate the risks. About 40% of violations in drug ads cited by the FDA between 2004 and 2013 relate to "risk minimization." That's twice the percentage of violations relating to "overstated efficacy" (see chart here: Do TV DTC Ads Overstate Rx Drug Risks?).

more...
No comment yet.