Drug Safety Developments

Generic Version of Popular ED Drug Viagra is Now Available

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

Generic Viagra

Teva Pharmaceutical Industries is launching a generic form of Viagra, a popular drug used for erectile dysfunction (ED).  The press release announced that the generic version would be made available on December 11, 2017. 

This new generic Viagra, simply referred to as "sildenafil tablets" on Teva's website, will be available in the same doses as Viagra at approximately half the cost.  Teva has also mentioned offering additional savings to eligible patients.

Until June 9, 2018, Teva has been granted exclusivity by the FDA over manufacturing of this new generic Viagra.  After that point in time, other companies will be allowed to manufacture and market their own generic versions of Viagra.

 

Manufacturer Competition

While Pfizer Inc., the original manufacturer of Viagra, once dominated the ED drug market, their sales have slowly declined as more ED drugs have become available such as Levitra and Cialis, manufactured by GlaxoSmithKline and Eli Lilly and Company, respectively.  Teva's generic Viagra further threatens Pfizer's revenue.

In hopes of clinging to as much of the market as possible, Pfizer has also decided to sell an "authorized generic" version of its drug.  A recent MedScape article provides more information:

New York–based Pfizer will start selling what's known as an "authorized generic," manufactured by its subsidiary Greenstone LLC, priced at $30 to $35 per pill, a company spokesman told Medscape Medical News. That's roughly half or less of the $65-a-pill cost for Viagra seen on pharmacy websites. 

The manufacturer of this authorized generic Viagra, Greenstone, recently released its Product Fact Sheet, which provides information on dose availability and other technical information for the new generic ED drug.

However, generic Viagra isn't the only cost-effective alternative to traditional Viagra treatment of ED.  Revatio is another drug manufactured by Pfizer that can be used to treat ED, and it has the same active ingredient as Viagra (sildenafil).  The only difference between Revatio and Viagra is the dosage amount: Viagra is available in 25, 50, or 100mg doses, while Revatio is typically available in 5mg or 20mg doses.  Revatio has also been available in generic form for several years.

 

Side Effects

While a cheaper, generic version of Viagra will be good news for those who couldn't afford the brand-name drug, it is important to keep in mind the adverse side effects of these drugs, often referred to as phosphodiesterase type 5 (PDE5) inhibitors.

The drug label for Teva's sildenafil tablets (revised 8/2017, accessed 12/11/17) warns against a type of sudden vision loss called Nonarteritic Anterior Ischemic Optic Neuropathy (NAION).  To read more about this side effect, see Attorney Tom Lamb's recent blog post.

Not included, however, is the serious side effect of melanoma skin cancer.  Many lawsuits have already been filed concerning patients who have been diagnosed with melanoma after using Viagra and Cialis. 

Here are several recent articles written by our firm on the association of ED drugs with melanoma:

• 11/1/17 - 2017 Medical Articles: Association Of Melanoma With Viagra And Cialis
• 5/30/17 - New Study Suggests Erectile Dysfunction Drugs May Not Cause Melanoma
• 10/19/16 - Viagra – Melanoma MDL Might Include Cialis Lawsuits And Levitra Cases

 

Effects on Lawsuits

While the Supreme Court's ruling in Pliva, Inc., et al. v. Mensing typically protects manufacturers of generic drugs from any "failure to warn" lawsuits, this new generic form of Viagra may not fall under the umbrella of that ruling.

Given that Pfizer is the original manufacturer of Viagra and its subsidiary, Greenstone, will be manufacturing their new authorized generic version of the drug, it may still be vulnerable to lawsuits brought forth by users of the generic Viagra.

However, the same exception may not apply to Teva's generic version of Viagra.

We will continue to monitor the medical literature concerning ED drugs -- also referred to as PDE5 inhibitors -- and an increased risk of melanoma skin cancer and other serious side effects.

In the meantime, we encourage you to visit our website to learn more, and complete a free case evaluation if you or someone you know has been diagnosed with melanoma or sudden vision loss after using Viagra, Cialis, or some other ED drug.

 

 

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New Study Suggests Erectile Dysfunction Drugs May Not Cause Melanoma

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

A recent study found in the Journal of the National Cancer Institute assessed the relationship between melanoma skin cancer and erectile dysfunction (ED) drugs like Viagra, Cialis, and Levitra.  Contrary to prior studies on this subject, they suggested that there may not be a link after all.

This new study conducted a review of previous studies that suggested ED drugs--also referred to as Phosphodiesterase inhibitors (PDE5i)--were associated with an increased risk for melanoma development.

They argued that the prior studies failed to identify certain confounding factors such as sun exposure, lifestyle factors, and socioeconomic status.  They expound on these notions, below:

Notably, both PDE5i use and skin cancer are strongly associated with socioeconomic status, suggesting potential for confounding by lifestyle factors. The increased risk of in situ melanoma among PDE5i users and reduction in advanced disease also raises the possibility of detection bias.

A Medscape article provides further explanation, saying, "the group of patients likely to take medicines for ED also happens to be more health conscious, more likely to see a physician, and so more likely to be diagnosed with melanoma than other men of similar age."

Here are the findings of this most recent study:

• Only low PDE5i exposure was associated with increased risk (RR = 1.15, 95% CI = 1.01 to 1.31), whereas high exposure was not (RR = 1.09, 95% CI = 0.97 to 1.23).
• High PDE5i exposure was associated with an increased risk of stage 0 melanoma (RR = 1.45, 95% CI = 1.09 to 1.92), but decreased risk of stage II to IV melanoma (RR = 0.67, 95% CI = 0.46 to 0.97).
• The risk for melanoma was increased by 11%, at a relative risk (RR) of 1.11, compared to those who did not use PDE5 inhibitors.

While the researchers state that "Our meta-analysis of four observational studies on PDE5i and melanoma found a statistically significant association," they are quick to point out that "it did not meet five of Hill’s nine causal criteria, suggesting against a causal relationship."

A summary of the implications of these findings is provided by the following Science Daily article:

The researchers found an overall increase in melanoma risk among men who used PDE5 inhibitors, but they hypothesized that if a cause and effect exists, higher use of erection medications would be associated with higher risk of developing the disease. Loeb and her colleagues found the opposite: there was an increase in risk among men who had a small amount of exposure to these medications, and men who took larger amounts of erectile dysfunction medications had no significant increase in melanoma risk.

Essentially, the researchers of this most recent study argue that "Overall, Viagra (sildenafil, Pfizer Inc) and other PDE inhibitors are safe medications as long as men are not taking nitrates, which carry a risk of reducing blood pressure."

However, we will continue to monitor the medical literature for updates concerning PDE5 inhibitors and an increased risk of melanoma skin cancer.

In the meantime, we encourage you to visit our website to learn more, and complete a free case evaluation if you or someone you know has been diagnosed with melanoma after using Viagra, Cialis, or Levitra.

 

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Not Just Viagra: Cialis & Levitra also Linked to Melanoma Skin Cancer

 

Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.

 

On June 30, 2016, the FDA announced that it would investigate the possible link between skin melanomas and erectile dysfunction (ED) drugs such as Viagra, Cialis, and Levitra. 

This recent announcement from the FDA Adverse Event Reporting System (FAERS) included all of the following PDE-5 inhibitors:

• Adcirca (tadalafil)
• Cialis (tadalafil)
• Levitra (vardenafil hydrochloride) 
• Revatio (sildenafil citrate)
• Staxyn (vardenafil hydrochloride) 
• Stendra (avanafil)
• Viagra (sildenafil citrate)

As regards the FAERS, this Medscape article brings up a valid point:

A drug's appearance on a quarterly FAERS watch list does not mean the FDA has determined there is a cause-and-effect relationship between the drug and the cited adverse event. Instead, the agency evaluates the need for regulatory action. If its investigation uncovers a causal link, the agency could gather more information to better describe the threat, revise the drug's label, require a Risk Evaluation and Mitigation Strategy, or in extreme cases, pull the drug from the market.

However, the article from the Journal of the American Medical Association, "Use of Phosphodiesterase Type 5 Inhibitors for Erectile Dysfunction and Risk of Malignant Melanoma," notes that for melanoma, "the risk estimates were similar for sildenafil and vardenafil or tadalafil."

Additionally, they performed a separate analysis of men who only ever used Viagra, and those who only used Cialis or Levitra.  The results are listed in the table, below:

The researchers note that "the association with melanoma was similar for the 3 PDE5 inhibitors...[and] there was a statistically significant association with melanoma in men who used sildenafil only (OR, 1.26 [95% CI, 1.08-1.48]) and vardenafil or tadalafil only (OR, 1.30 [95% CI, 1.08-1.57])."

While there seem to be more studies readily available concerning the relationship between melanoma and Viagra (sildenafil), the article "Sildenafil use and increased risk of incident melanoma in US men: a prospective cohort study" states that this may be due to the fact that researchers "did not have the information on other PDE5A inhibitors because neither vardenafil (Levitra) nor tadalafil (Cialis) had been approved by FDA in 2000."  They go on to state that "the observed association between sildenafil use and melanoma might be partly attributed to the later use of vardenafil and tadalafil among recent sildenafil users."

Lastly, the article "Sildenafil Potentiates a cGMP-Dependent Pathway to Promote Melanoma Growth" warns that "the use of sildenafil (Viagra) or other PDE5 inhibitors like vardenafil (Levitra) or tadalafil (Cialis) could promote melanoma in humans."  This article later states that "Dynamic cGMP measurements in living 1205Lu cells confirmed these results and showed that in addition to sildenafil, cGMP signals were also enhanced by two other clinically used PDE5 inhibitors, tadalafil and vardenafil."

While the main legal focus is currently on the relationship between Viagra and melanoma skin cancer, more lawsuits concerning those who have taken Cialis and Levitra and been diagnosed with melanoma should be filed in the near future, based on the aforementioned research.

As such, we will continue to monitor the medical literature concerning Viagra, Cialis, and Levitra, and their link to melanoma skin cancer.

 

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Viagra May Boost Risk of Deadly Skin Cancer, Study Finds

Quoted from http://www.nbcnews.com/health/health-news/viagra-may-boost-risk-deadly-skin-cancer-study-finds-n73976

Viagra May Boost Risk of Deadly Skin Cancer, Study Finds

By JoNel Aleccia

Men who use Viagra to get a boost in the bedroom could find that the little blue pill also increases the risk of developing melanoma, the deadliest form of skin cancer, a preliminary study finds.

Researchers found that men who took sildenafil, best known as Viagra, were about 84 percent more likely to develop melanoma than men who didn’t take the drug.

Because it’s just one early study, no one is suggesting that men stop taking Viagra to treat erectile dysfunction, said Dr. Abrar Qureshi, professor and chair of the dermatology department in the Warren Alpert Medical School at Brown University.

“But people who are on the medication and who have a high risk for developing melanoma may consider touching base with their primary care providers,” said Qureshi, co-author of the study of nearly 26,000 men published Monday in JAMA Internal Medicine.

[Article continues at original source]

FDA warns Pfizer for not reporting side effects

Quoted from http://www.reuters.com/article/idUSTRE6586PE20100610

FDA warns Pfizer for not reporting side effects

Susan Heavey

Thu Jun 10, 2010 6:59am EDT

WASHINGTON (Reuters) - The U.S. Food and Drug Administration has warned Pfizer Inc for failing to quickly report serious and unexpected potential side effects from its drugs already on the market.

In a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler, the FDA cited numerous examples involving some of the company's top-known brands, including impotence drug Viagra, cholesterol pill Lipitor and seizure medicine Lyrica.

The delays in reporting side effects date back as far as 2004 and have grown in recent years, according to the FDA's letter that was released by Pfizer on Wednesday.

Ronald Pace, director of the FDA's New York office, told Pfizer in the letter dated May 26 that it had not properly documented or investigated reported problems in patients after the drugs were approved for use.

"FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated," Pace wrote.

Pace asked Kindler to arrange a meeting between the company and the agency over the violations. Pfizer said it received the letter June 3.

The FDA conducted a 6-week inspection of Pfizer's New York headquarters in July and August of 2009, where agency inspectors found system-wide lapses at the world's largest drugmaker.

The patient reports "contained serious and unexpected adverse events... that were not submitted until they were identified during the FDA inspection," Pace wrote. Efforts to fix the problem "have been shown to be ineffective," he added.

In a statement, Pfizer said it would work with the FDA to satisfy the agency "and to assure optimal surveillance and reporting of post-marketing adverse events."

[Article continues at original source]