Drug Safety Developments

Lyrica May Be Linked to an Increased Risk of Major Birth Defects

 

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

 

Lyrica (pregabalin) is often prescribed for various conditions and health issues such as epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder.  

According to the study described in a recent journal article published in Neurology, women who took Lyrica during the first trimester of their pregnancy were three times more likely to have children with birth defects than women who did not take Lyrica while pregnant.  Additionally, the infants of women who took Lyrica were six times more likely to have central nervous system defects.

The other major birth defects observed in this study include heart defects and issues with various organs.

Of note, the total percentage of women who had children with birth defects after taking Lyrica was six percent, compared to two percent of women who did not take Lyrica.  

This HealthDay article provides some additional information on the matter:

"These results should be taken with caution," said study senior author Dr. Thierry Buclin, from the Swiss Teratogen Information Service and the division of clinical pharmacology at the Lausanne University Hospital, in Switzerland. "It's a warning, but it cannot be taken as a certainty...We should not unduly alarm mothers-to-be about a definite risk. This is just a signal, a warning that there might be a problem with Lyrica," he said.

Experiments in animals have also linked Lyrica to birth defects, Buclin said. "But there are many examples of drugs showing an adverse effect, which turn out to be rather safe in humans," he explained.

Buclin doesn't currently recommend Lyrica for women who are thinking about becoming pregnant.

Seemingly, the results of the aforementioned study are not enough to definitively say that Lyrica causes an increased number of major birth defects, and more research is needed.  However, there is still cause for concern, and women who are pregnant -- or plan to become pregnant -- should avoid taking Lyrica.

We will continue to monitor the medical literature for additional research concerning the link between taking Lyrica during the first trimester of pregnancy and an increased risk of major birth defects.

 

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Health Canada Warns About Link Between DKA & Popular Diabetes Drugs

 

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

 

The link between diabetic ketoacidosis (DKA) and SGLT2 inhibitor treatment for type 1 and type 2 diabetes has been previously established through studies conducted by the EMA and the American Diabetes Association.  

For more information on the EMA's warning, see my previous article, "EMA Advises How to Reduce DKA Risk While Taking SGLT2 Inhibitors."  Information from the American Diabetes Association on the link between DKA and Invokana / Invokamet, specifically, can be found in my article, "Canagliflozin Also Causes DKA in Those With Type 1 Diabetes."

On May 16, 2016, Health Canada released additional information regarding the SGLT2 inhibitors Invokana, Farxiga / Forxiga (Europe), Xigduo, and Jardiance.  In their article, they provide the following information:

• Serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis (DKA) have been reported in patients on sodium glucose co-transporter 2 (SGLT2) inhibitors for type 1 and type 2 diabetes.
• In a number of these cases, the presentation of the condition was atypical with only moderately increased blood glucose levels observed.
• SGLT2 inhibitors are NOT indicated for treatment of type 1 diabetes mellitus and should not be used in type 1 diabetes.
• It is recommended that:
  • if DKA is suspected or diagnosed, treatment with SGLT2 inhibitors should be discontinued immediately.
  • SGLT2 inhibitors should not be used in patients with a history of DKA.
  • in clinical situations known to predispose to ketoacidosis (e.g. major surgical procedures, serious infections and acute serious illness), consideration be given to temporarily discontinuing SGLT2 inhibitor therapy.
  • patients be informed of the signs and symptoms of DKA and be advised to immediately seek medical attention if they develop them.
  • caution be used before initiating SGLT2 inhibitor treatment in patients with risk factors for DKA.

In summary, Health Canada states that patients with type 1 and type 2 diabetes mellitus who have used SGLT2 inhibitors are at an increased risk for DKA, according to clinical trials and reported post-market cases.  Additionally, the majority of the patients involved in the aforementioned trials and reports required hospitalization, many after taking SGLT2 inhibitors for only two months.

They also found that among some patients diagnosed with DKA after using SGLT2 inhibitors, their blood glucose levels were only moderately increased.  As such, there is a higher chance of delayed diagnosis and treatment, putting the patient at greater risk for hospitalization, and even death.

Health Canada gives the following warning to those taking Invokana, Farxiga / Forxiga (Europe), Xigduo, or Jardiance: 

Patients taking any of these medicines should be aware of the symptoms of DKA, including loss of appetite, nausea or vomiting, stomach pain, feeling very thirsty, rapid breathing, confusion, feeling unusual tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.

Patients should immediately seek medical advice if they develop any of these symptoms. Patients should also inform their healthcare professional about medical issues or factors (see below) that may predispose them to ketoacidosis.

We will continue to monitor the medical literature concerning these SGLT2 inhibitors and an increased risk of DKA, and report on any additional findings.

 

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More articles on this topic:

• Canagliflozin Also Causes DKA in Those With Type 1 Diabetes
• EMA Advises How to Reduce DKA Risk While Taking SGLT2 Inhibitors
• U.S. FDA warns on newer class of type 2 diabetes drugs

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Additional Cases of PML Found Among Those Taking Tecfidera

 

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

 

According to the FDA drug label for Tecfidera approved on December 3, 2014, only one case of progressive multifocal leukoencephalopathy (PML) was found to be linked to the multiple sclerosis (MS) drug, Tecfidera (dimethyl fumarate), manufactured by Biogen, Inc.  

However, a fourth case was recently reported in December 2015, which led to an increased warning of this dangerous possible side effect of Tecfidera. Attorney Tom Lamb discusses the FDA's warning in his recent article, "A Tecfidera Label Change Modifying Warnings About Progressive Multifocal Leukoencephalopathy (PML) Was Done In February 2016 With Little Notice."

The first three cases of Tecfidera-induced PML occurred among patients with prolonged severe lymphopenia (low lymphocyte count), but Kristina Fiore reports in her MedPage Today article that the most recent case occurred among "a patient with only moderate lymphopenia...raising new questions about the drug's safety" (emphasis added).

Of note, these initial cases "occurred in patients treated with dimethyl fumarate who had not previously received other drugs, such as [Tysabri] natalizumab, known to be associated with a risk for PML" according to "New EMA Advice on PML Prevention With Dimethyl Fumarate (Tecfidera) in MS."  

Though the most recent case involved a patient who was previously treated with Tysabri, she stopped such treatment two months prior to starting Tecfidera, and was diagnosed with PML just shy of two years later, as discussed in this MedScape article.  Additionally, Fiore states in her aforementioned article that "the company said that prior exposure wasn't considered a confounder in this case."  

This goes to show that even though Tecfidera is typically regarded as one of the "safer" immunosuppressant agents, it still has the potential to cause dangerous adverse side effects.

As a precautionary measure, the European Medicines Agency encourages doctors to continuously monitor the lymphocyte counts of their patients, and check for the presence of JC virus infection before they consider prescribing Tecfidera.  

We will continue to monitor the medical literature concerning the link between Tecfidera and PML, and report on any new cases of PML that arise due to Tecfidera treatment.

 

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Possible Birth Defects Among Neonates of Pregnant Women Taking Zofran

 

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

 

There is an increased chance of cardiac abnormalities when a child is exposed to Zofran (ondansetron) while in utero.  This information is found in the May 2016 article recently released by Obstetrics & Gynecology, "Ondansetron Use in Pregnancy and Birth Defects: A Systematic Review" (subscription or payment may be required for full article text).

Here are the conclusions of the aforementioned article, as mentioned in the Abstract:

The overall risk of birth defects associated with ondansetron exposure appears to be low. There may be a small increase in the incidence of cardiac abnormalities in ondansetron-exposed neonates. Therefore, ondansetron use for nausea and vomiting of pregnancy should be reserved for those women whose symptoms have not been adequately controlled by other methods.

These findings were derived from various studies involving women who took Zofran in the early stages of their pregnancy to mitigate nausea and vomiting.

However, it is also important to note that some of the data collected in the studies analyzed by this article was conflicting.  For example, the Practice Update article, "Review: Low Risk of Birth Defects With Ondansetron Exposure," states that "the three largest studies showed no increased risk of birth defects" and "the risk of cardiac defects was slightly increased" in two of these studies, but "this finding was not replicated in other studies."

In any case, women who are pregnant should be wary of taking Zofran for morning sickness during the early stages of their pregnancy, due to the possible chance that it could cause cardiac abnormalities in their unborn child.

We will continue to monitor the medical literature concerning the relationship between the risk of birth defects among the offspring of women who took Zofran in the early stages of their pregnancy.

 

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