Archive for the ‘Dangerous Drugs’ Category

SSRI Medications Significantly Increase Fracture Risk

Although selective serotonin reuptake inhibitors (SSRIs) such as Zoloft are widely prescribed to treat depression, panic disorder, obsessive-compulsive disorder, and post-traumatic stress disorder, a number of serious side effects and risks have come to light involving these medications. Hundreds of lawsuits have already been filed as plaintiffs take action against the makers of SSRI drugs for these dangerous unexpected side effects, but even as litigation is pending, new problems are arising.  

One new study presented at the annual meeting of the American Society for Bone and Mineral Research demonstrates that the SSRI fracture risk among post-menopausal women exceeds the fracture risk associated with corticosteroids and PPIs. Older women who use SSRI drugs and who suffer a fracture should consider a dangerous drug lawsuit in San Antonio to hold drug makers responsible for injuries.

SSRI Study Shows Magnitude of Bone Fracture Risk

The link between SSRIs and bone fractures has been well established by medical studies. In 2012, researchers published the results on PubMed of their careful review of information from 12 prior studies on SSRI fracture risks. Adjusting for variables and other risk factors, the researchers from the Department of Family Medicine determined that “fracture risk associated with SSRI use may have a significant clinical impact.” Research has also demonstrated an increased risk of falls in dementia patients prescribed SSRI drugs. Seniors with dementia have a lengthy recovery period from bone fractures and may not recover fully from the bone break or associated complications.

This past data, however, had not fully identified the magnitude of the effect of SSRIs on bone fractures. The new study attempted to assess just how badly SSRIs affect bone density. The study involved comparing the risk of fractures in patients taking SSRIs versus the risks in patients taking PPIs and corticosteroids.  Both PPIs and glucocorticoids are well-known for their strong link to fractures, and researchers believe understanding the relative fracture risk of these medications versus SSRIs is helpful because there are clear guidelines for preventing glucocorticoid-induced osteoporosis but not for SSRI-induced osteoporosis.

The study compared incidents of reported fractures over a five year period among women using one of the three drugs: SSRIs, glucocorticoids (GCs) and PPIs. Women aged 55 and up in 10 countries from 615 primary care practices were included in the study.  A total of 9,347 of the women had not been treated with SSRIs, GCs or PPIs while 2,715 used PPIs, 5304 used GCs and 1,149 used SSRIs.

Researchers found anxiety was the highest in the SSRI patients, and that after five years, SSRIs were the only therapy that showed a significant increase in the risk of overall fractures, nonhip/nonvertebral fractures and clinical spine fractures.

This is bad news for patients as the results mean the risk of fractures caused by SSRIs may actually be greater than the risk caused by corticosteroids and PPIs. Patients need to be aware of the magnitude of the risk and should take legal action if they believe the SSRI manufacturer failed to adequately warn them about the dangers associated with SSRI use.

If you believe you should pursue a dangerous drugs lawsuit, contact the Herrera Law Firm at 800-455-1054 for a free case consultation.

Texas Compounding Pharmacy Recalls Dangerous Drugs After Patients Suffer Infections

According to USA Today, a nationwide voluntary recall was announced in August after 15 patients throughout Texas developed infections following an injection of calcium gluconate. The bacterial bloodstream infections the patients developed are believed to have been linked to contamination at a compounding pharmacy.

Patients who have developed infections due to their use of a medication may be able to file a dangerous drugs lawsuit in San Antonio and/or in the location where the drugs were produced or infection occurred.  A dangerous drugs lawsuit can allow injured victims to recover monetary compensation for their losses.  Unfortunately, such claims continue to be necessary to hold these compounding pharmacies responsible.

Compounding pharmacies have become a major public health concern due to repeated contamination issues. In fact, the federal government is now aiming to change the way in which compounding pharmacies are regulated in order to try to prevent more patients from being harmed by unsafe medications produced at these pharmacies.

Dangerous Drugs from Compounding Pharmacies Put Patients at Risk

According to USA Today, the voluntary recall that occurred in August was one of several this year.  Earlier in August, a compounding pharmacy, Nexus Pharmaceuticals, voluntarily recalled injectable benztropine mesylate, which is used to treat Parkinson’s disease.  In July, a pharmacy called Beacon Hill Medical Pharmacy instituted a recall when questions were raised regarding whether its products were sterile. Finally, in June, Fresenius Kabi USA recalled four lots of benztropine mesylate injections because of potential contamination with glass particles.

In Texas, an organism called Rhodococcus equi, which was found in the calcium gluconate, was believed to have been the cause of the 15 reported infections.

While the Texas recall was the worst of the most recent recalls because people actually got sick, the extent of the damage did not come close to the outbreak of fungal meningitis that was prompted by contaminated vials of medication from New England Compounding Center. That outbreak resulted in almost 50 deaths from meningitis and more than 700 people becoming ill.

Changing Rules on Compounding Pharmacy Regulation

Compounding pharmacies were originally intended to be small-scale operations that produced specific drugs for specific patients when the necessary medication was not available in pre-made form on the market. Many compounding pharmacies now serve as de-facto drug manufacturers and produced medications that are distributed nationwide. This is the case with the pharmacies recently forced to recall drugs.

Their role as de-facto drug manufacturers means that if something goes wrong, many hundreds or even thousands of people could get hurt. Yet, the compounding pharmacies are still largely regulated by individual state pharmacy boards, which don’t have the resources or means to ensure the pharmacies are safe.  New proposals suggest putting the compounding pharmacies under the purview of the FDA.  Hopefully, this could help to prevent more injuries and more harm to patients who depend upon drugs produced at compounding pharmacies.

If you believe you should pursue a dangerous drugs lawsuit, contact the Herrera Law Firm at 800-455-1054 for a free case evaluation.

Dangerous Drugs in Texas – Steroid Linked to Deadly Meningitis Outbreak

A contaminated drug — in this case an injectable steroid for back pain — has sickened more than 200 patients and claimed fifteen lives in the past week.

The medical crisis has quickly escalated —CNN reports seven new deaths were reported over the weekend. The Centers for Disease Control and Prevention is now reporting a total of 205 cases of fungal meningitis, believed caused by contaminated steroids from the New England Compounding Center. As many as 14,000 people may have received the injections.

Texas defective drug attorneys understand that this is far from an isolated incident.Compounding centers mix customized drugs for hospitals, pharmacies and medical centers. While the products they use are approved by the Food & Drug Administration, the final product is not subject to the same control measures. States are responsible for control measures at compounding pharmacies. In this case, the governor of Massachusetts is already indicating the facility may have misled state licensing agencies.

The truth of the matter is that the Food & Drug Administration wins no awards when it comes to ensuring the safety of the drugs it does approve. Loopholes, including ones that permit such mixing and compounding facilities, only add to the challenges when it comes to keeping consumers safe.

Patients in this case may be at particularly high risk because back injections are a direct means of contracting meningitis, which is an inflammation of the protective membrane around the brain and spinal column. Meningitis is a life-threatening health crisis. Symptoms may include confusion, discomfort, dizziness, headaches, dizziness and nausea. A number of victim’s have suffered strokes.

The Fort Worth Star-Telegram reports patients have been diagnosed in Texas, Florida, Idaho, Illinois, Maryland, Indiana, Michigan, Minnesota, New Jersey, North Carolina, Tennessee, Ohio, Texas and Virginia.The steroid is a methylprednisolone acetate suspension. Three lots have been recalled and clinicians in 23 states are calling patients. Authorities are concerned about an onslaught of diagnosed cases because most have been diagnosed nearly three weeks after injection.

“If patients are having new or worsening symptoms, even mild symptoms, they should be evaluated immediately,” said Benjamin Park, of the CDC.

The three lots, according to the Massachusetts Board of Registration in Pharmacy, are 05212012@68, 06292012@26, and 08102012@51.

The media is reporting it’s not the first time the New England facility has been in trouble with federal authorities over unsafe practices that either resulted or could have resulted in contaminated drugs. In this case, the FDA says at least one unopened vial at the facility has tested positive for fungal meningitis.

As NBC News reports, this case has clinics and medical facilities reviewing where they receive drugs and other pharmaceutical products. But the reality is that many health care facilities are turning to discount operators or oversees pharmaceutical companies to reduce costs. When combined with lax federal oversight, the consequences are too often deadly.

If you’ve been injured by a dangerous drug or medical product, contact the Herrera Law Firm at 800-455-1054 for a confidential consultation.