Risperdal Consta Recalled due to Mold

Drug recall lawyers at Pintas & Mullins Law Firm report that Johnson & Johnson recently initiated a recall of its antipsychotic drug Risperdal Consta after discovering mold during testing. Between 5,000 and 70,000 vials may be contaminated.

There has been increased oversight in to Johnson & Johnson manufacturing plants in recent years after dozens of recalls by the big pharma company, including several children’s products. Thousands of Risperdal Consta vials that could be contaminated with mold are currently sitting in doctor’s offices, mental health centers, and pharmacies nationwide. Fortunately, patients are not permitted to keep or take home vials of the strong antipsychotic, so the recall extends only to physicians and pharmacies.

In a letter to physicians on its website, J&J affirms that the mold Alternaria alternata was found during routine testing and could cause infections around the area where the injection is administered. Patients with compromised immune systems, or the elderly, are at significantly increased risk of systemic infection.

Alternaria alternate is typically found in homes and is the most common fungi associated with asthma symptoms, persistence and severity. Risperdal Consta is one of the company’s best-selling drugs, approved by the FDA to treat an array of mental disorders ranging from obsessive-compulsive disorder (OCD), schizophrenia, and bipolar disorder. Risperdal and other popular antipsychotics have also been known to be used in a variety of exceedingly dangerous off-label treatments, such as for residents of nursing homes with dementia.

The FDA blatantly forbids the use of Risperdal Consta in elderly patients with dementia-related psychosis due to the significantly increased risk of death. However, nursing homes throughout the country, particularly those that are chronically understaffed or underfunded, continue to administer antipsychotics to “unruly” dementia patients in effort to subdue and restrain them.

This is known as “chemical restraints,” and more information on this troubling practice can be found here. Our latest story on the topic highlights the Obama administration’s recent gains in this field, reducing the use of antipsychotics in nursing homes by more than 9% in the last two years.

In August 2010 the FDA changed Risperdal Consta’s labels to reflect several adverse reactions possible with the injections. Among these include abdominal pain, insomnia, respiratory tract infections, diabetes mellitus, and pruritus generalized.

Recent medical studies have also found little to no benefit of Risperdal Consta drug treatment in patients with OCD over cognitive behavioral therapy. The study, conducted by researchers at Columbia University and published in JAMA Psychiatry, assigned OCD patients to a behavioral therapy program for eight weeks (90 minutes, twice a week), and found that they scored much higher in disorder reductions than those given Risperdal Consta. Adverse event reports were also less common among patients assigned talk-therapy sessions.

The study authors concluded that OCD patients, particularly those already on antidepressants, should receive talk-therapy before being prescribed an antipsychotic. Risperdal Consta is commonly given to patients not responding to antidepressants alone, however, studies of this kind suggest that this practice may be causing more harm than good, and alternative methods should be considered.

Despite mounting evidence to the ineffectiveness of antipsychotics, Risperdal Consta continues to reap sales of about $1.4 billion per year. The recall extends to vials of 25 mgs, lot number 309316, shipped between January 14 and May 20, 2013. Doctors, physicians and nurses can call 1.800.526.7736 for more information.

Antipsychotic lawyers at Pintas & Mullins Law Firm have decades of experience advocating on behalf of those seriously injured or sickened by recalled or contaminated drugs. If you or a loved one was injected with a contaminated lot of Risperdal Consta, or received the medication for uses not approved by the FDA (such as in elderly patients with dementia), contact one of our skilled attorneys as soon as possible for a free legal evaluation.

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