Selective Serotonin Reuptake Inhibitors (SSRIs) are types of antidepressants. Brand names of SSRIs include: Paxil, Zoloft, Celexa, Prozac, Lexapro, Symbyax, Wellbutrin and Effexor. These drugs inhibit neuronal serotonin and norepinephrine reuptake and slightly inhibit dopamine reuptake. SSRIs have been associated with serious, life-threatening birth defects. Research suggests that, if a mother took SSRI’s during pregnancy, [...]
SC AG Files Lawsuit Against GSK for Improper Marketing of Diabetes Drug
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March 23, 2010
Actos Whistleblower Lawsuit Alleges Takeda Pharmaceuticals Attempted to Influence Reports of Actos Side Effects.
(PRWEB) On 3/19/12, the Consumer Justice Foundation alerted the public of allegations made in an Actos whistleblower lawsuit that accused Takeda Pharmaceuticals of influencing reports of risks of potential Actos side effects. Actos Whistleblower PRWeb Release 3.19.12
The FDA approved Actos for use in the United States in 1999 to treat symptoms relating to Type II Diabetes. Actos has been banned from use in Germany and France because of the potential risk of long-term use and bladder cancer. On June 15, 2011, the FDA published a public warning alerting long-term American users of Actos of the same risk. Actos FDA-6.15.11-Safety-Announcement
If you or a family member took Actos, ACTOplus met, actoplus met xr or duetact to treat diabetes for more than one year and have been diagnosed with bladder cancer, please contact us. John Evans (jcevans@ssem.com), one of our experienced pharmaceutical attorneys, would be pleased to assist you in seeking legal remedies.
If you or a family member took Actos, ACTOplus met, actoplus met xr or duetact to treat diabetes and suffered a heart attack or stroke, we would be interested in speaking with you. Please email Mr. Evans at jcevans@ssem.com or give him a call at 1-800-642-5297.
You may also complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.
SSRI Use Associated with Birth Defects
Selective Serotonin Reuptake Inhibitors (SSRIs) are types of antidepressants. Brand names of SSRIs include: Paxil, Zoloft, Celexa, Prozac, Lexapro, Symbyax, Wellbutrin and Effexor. These drugs inhibit neuronal serotonin and norepinephrine reuptake and slightly inhibit dopamine reuptake. SSRIs have been associated with serious, life-threatening birth defects.
Research suggests that, if a mother took SSRI’s during pregnancy, the infant could be at increased risk of the following:
• Heart defects
• Persistent Pulmonary Hypertension of a Newborn (PPHN)
• Lung defects
• Brain and spinal cord defects
• Abdominal wall defects
• Limb defects, and
• Congenital abnormalities
On December 14, 2011, the U.S. Food and Drug Administration issued a safety announcement advising the public that there are conflicting findings from new studies evaluation this potential risk, making it unclear whether use of SSRIs during pregnancy can cause Persistent Pulmonary Hypertension of a Newborn (PPHN). 12.14.2011 FDA Safety Announcement
If you took an antidepressant during pregnancy and your child suffered any of the birth defects that are identified, we would like to speak with you to determine if those defects were caused by your medication. There is no obligation to you and the inquiry is free.
Please email Attorney John Evans at jcevans@ssem.com or give him a call at 1-800-642-5297.
You may also complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.
Diabetes Drug Actos Linked to Bladder Cancer
Actos (generically known as pioglitazone), ACTOplus met (pioglitazone HCI and metformin HCI), Actoplus met xr (pioglitazone HCI and metformin HCI extended-release) and Duetact (pioglitazone HCI and glimepiride) are used to treat type 2 diabetes. The manufacturers of Actos (pioglitazone) warned doctors that the drug may cause or worsen congestive heart failure and that Actoplus met and Actoplus met xr can cause lactic acidosis, but did not warn that the drug may cause bladder cancer.
On July 15, 2011, the FDA announced (FDA 6.15.11 Safety Announcement) that the use of the diabetes medication Actos for more than a year may be associated with an increased risk of bladder cancer. The agency’s information was based on its review of data from an ongoing ten-year study. That study showed that an increased risk of bladder cancer was noted among patients with the longest exposure to Actos and the highest cumulative dose of Actos.
“The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” (FDA 6/15/11 Announcement.) This finding prompted the FDA to add a warning to the medication label.
Diabetes Drug Actos May Increase Risk of Bladder Cancer
We represent people with diabetes who took Actos, ACTOplus met, actoplus met xr and duetact for more than one year and have been diagnosed with bladder cancer. We are also investigating potential claims of people who took Actos and had a heart attack or stroke.
Our firm will investigate and personally work your case, in contrast with many websites that advertise for leads and then sell your inquiry to some unknown attorney.
Actos (generically known as pioglitazone), ACTOplus met (pioglitazone HCI and metformin HCI), Actoplus met xr (pioglitazone HCI and metformin HCI extended-release) and Duetact (pioglitazone HCI and glimepiride) are used to treat type 2 diabetes. The manufacturers of Actos (pioglitazone) warned doctors that the drug may cause or worsen congestive heart failure and that Actoplus met and Actoplus met xr can cause lactic acidosis, but did not warn that the drug may cause bladder cancer.
On July 15, 2011, the FDA announced (FDA 6.15.11 Safety Announcement) that the use of the diabetes medication Actos for more than a year may be associated with an increased risk of bladder cancer. The agency’s information was based on its review of data from an ongoing ten-year study. That study showed that an increased risk of bladder cancer was noted among patients with the longest exposure to Actos and the highest cumulative dose of Actos.
“The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” (FDA 6/15/11 Announcement.) This finding prompted the FDA to add a warning to the medication label.
Researchers have only recognized a few things as causing bladder cancer (parasitic infection, radiation and chemical exposure). (Source: Mayo Clinic. See, http://www.mayoclinic.com/health/bladder-cancer/DS00177/DSECTION=causes).
Actos is produced by Takeda Pharmaceuticals, Asia’s largest drugmaker, and has been one of the company’s most successful drugs. Actos is also one of the best selling diabetes medications on the market. According to industry analysts, from January through October 2010 approximately 2.3 million people filled prescriptions for Actos, bringing the company revenues of more than $2.6 billion. See patent information at: http://drugpatentwatch.com/ultimate/preview/tradename/index.php?query=ACTOS
Actos, ACTOplus met, actoplus met xr and duetact were seen as alternatives to the drug Avandia, whose maker just recently settled cases alleging that it was linked to strokes and heart attacks. According to John Evans, a partner at Specter Specter Evans & Manogue, P.C., “The makers of Avandia spent billions to settle lawsuits tied to Avandia. In the wake of problems associated with Avandia, doctors began prescribing Actos as safer alternative, causing its sales to skyrocket by the billions.”
Evans went on to say, “If the drugmaker knew of problems associated with its drug but suppressed the information to capitalize on the Avandia disaster, the company will be held accountable for both the drug and for suppressing information from doctors and patients. As Actos was marketed in the United States by Indianapolis-based Eli Lilly and Co., that company may also be responsible.”
If you or a family member took Actos, ACTOplus met, actoplus met xr or duetact to treat diabetes for more than one year and have been diagnosed with bladder cancer, please contact us. John Evans (jcevans@ssem.com), one of our experienced pharmaceutical attorneys, would be pleased to assist you in seeking legal remedies.
If you or a family member took Actos, ACTOplus met, actoplus met xr or duetact to treat diabetes and suffered a heart attack or stroke, we would be interested in speaking with you. Please email Mr. Evans at jcevans@ssem.com or give him a call at 1-800-642-5297.
You may also complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.
FDA Issues Safety Announcement on Contraceptives Containing Drospirenone
NPR (6/2, Knox) reported that the FDA issued a safety announcement prompted by two recent studies, involving hundreds of thousands of British and American women. The studies cast new doubt on drospirenone-containing pills — sold as Yaz, Yasmin, Ocella and a half-dozen other brand names.” Both “studies, published last month in the British Medical Journal, found a two- to three-fold higher incidence of serious deep-vein blood clots among women taking drospirenone pills compared to those on the older levonorgestrel contraceptives.” 5.31.11 Safety Announcement
SC AG Files Lawsuit Against GSK for Improper Marketing of Diabetes Drug
The Associated Press (6/1/11) reported that South Carolina Attorney General Alan Wilson filed suit May 17, 2011 against GlaxoSmithKline (GSK), alleging that GSK had improperly marketed the diabetes drug Avandia (rosiglitazone) to South Carolina consumers and hid the medication’s harmful side effects. In his complaint, Wilson argues “that the drugmaker acted negligently when it claimed that Avandia did not put patients’ hearts at risks and could actually reduce the potential for heart problems.”
FDA Tells Companies to Review Metal on Metal Artificial Hips
On 5/23/11, NPR reported (Neighmond) that the FDA requested companies that manufacture metal on metal artificial hips to take a closer look at patients’ recoveries post-implant. The FDA request was in response to “an increasing number of consumer complaints about the implants.” In addition, the FDA asked companies to collect blood samples from patients who have all metal implants in order to understand how much metal may be released into the bloodstream.
Avandia (Rosiglitazone) May Increase Risk for Certain Heart Conditions
According to HealthDay (3/17, Dotinga), the BMJ study published online relating to Avandia (Rosiglitazone) reported that the study authors “examined the results of 16 studies that involved more than 800,000 patients” who used Actos or Avandia and found a “‘modest but statistically significant increase in the odds of certain heart conditions in those who took Avandia.” Specifically, the risk of heart attack rose by 16 percent and increased 23 percent for congestive heart failure. Overall, mortality rates rose 14 percent.”
GSK Finalizes New Label Language for Avandia (rosiglitazone)
MedPage Today (2/7, Gever) reported that GlaxoSmithKline has finalized new label language for Avandia (rosiglitazone) restricting the drug’s use to patients already taking it or to those who have failed other antiglycemic drugs.” In addition, Avandia (rosiglitazone) ”may be started only in patients who ‘are unable to achieve adequate glycemic control on other diabetes medications, and, in consultation with their healthcare provider, have decided not to take pioglitazone (Actos) for medical reasons.’”
HeartWire (2/7, O’Riordan) reported that Avandia’s new label has been changed to highlight the increased cardiovascular risks, noting in a boxed warning that the drug was associated with a significantly increased risk of MI.” The new label also highlights the “lack of comparative clinical trials between rosiglitazone and pioglitazone but notes that pioglitazone, in a study compared with placebo, was not associated with an increased risk of death or MI.” In addition, the boxed warning “includes previous caveats that rosiglitazone is not recommended in patients with symptomatic heart failure and that it can exacerbate congestive heart failure in some patients.”
GSK to Settle Rosiglitazone (Avandia) Lawsuits
Bloomberg News (2/8, Feeley) reported that GlaxoSmithKline PLC agreed to pay more than $250 million to resolve about 5,500 claims related to its Avandia (rosiglitazone maleate) diabetes drug.” GlaxoSmithKline officials said they have updated Avandia’s warning label to include safety restrictions ordered by federal regulators, who cited studies showing the drug poses an increased risk of heart attack and stroke for some users. The label now warns users that the drug is only intended for consumers who can’t control their blood-sugar levels with other diabetes drugs.