Re: FDA Issues Complete Response Letter for RISPERDAL(R)

[Guest guest]

mimi says see note below

>

>> IMPORTANT SAFETY INFORMATION FOR RISPERDAL® CONSTA®

>

> Elderly Patients with dementia-related psychosis treated with

> atypical antipsychotic drugs are at an increased risk of death

> compared to placebo. RISPERDAL® CONSTA® (risperidone) is not

> approved for the treatment of patients with dementia-related

> psychosis.

>

> Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal

> side effect reported with RISPERDAL® CONSTA® and similar

> medicines. Call your doctor immediately if the person being treated

> develops symptoms such as high fever; stiff muscles; shaking;

> confusion; sweating; changes in pulse, heart rate, or blood pressure;

> or muscle pain and weakness. Treatment should be stopped if the

> person being treated has NMS.

>

> Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect

> reported with RISPERDAL® CONSTA® and similar medications. TD

> includes uncontrollable movements of the face, tongue, and other

> parts of the body. The risk of developing TD and the chance that it

> will become permanent is thought to increase with the length of

> therapy and the overall dose taken by the patient. This condition can

> develop after a brief period of therapy at low doses, although this

> is much less common. There is no known treatment for TD, but it may

> go away partially or completely if therapy is stopped.

>

> High blood sugar and diabetes have been reported with RISPERDAL®

> CONSTA® and similar medications. If the person being treated has

> diabetes or risk factors such as being overweight or a family history

> of diabetes, blood sugar testing should be performed at the beginning

> and throughout treatment with RISPERDAL® CONSTA®. Complications

> of diabetes can be serious and even life threatening. If signs of

> high blood sugar or diabetes develop, such as being thirsty all the

> time, going to the bathroom a lot, or feeling weak or hungry, contact

> your doctor.

>

> hyperprolactinemia. Blood levels of prolactin remain elevated with

> continued use. Some side effects seen with these medications include

> the absence of a menstrual period; breasts producing milk; the

> development of breasts by males; and the inability to achieve an

> erection. The connection between prolactin levels and side effects is

> unknown.

>

> Some people taking RISPERDAL® CONSTA® may feel faint or

> lightheaded when they stand up or sit up too quickly. By standing up

> or sitting up slowly and following your healthcare professional's

> dosing instructions, this side effect can be reduced or it may go

> away over time.

>

> RISPERDAL® CONSTA® may affect your alertness or driving ability;

> therefore, do not drive or operate machinery before talking to your

> healthcare professional.

>

> RISPERDAL® CONSTA® should be used cautiously in people with a

> seizure disorder, who have had seizures in the past, or who have

> conditions that increase their risk for seizures.

>

> Extrapyramidal Symptoms (EPS) are usually persistent movement

> disorders or muscle disturbances, such as restlessness, tremors, and

> muscle stiffness. If you observe any of these symptoms, talk to your

> healthcare professional.

>

> Inform your healthcare professional if you become pregnant or intend

> to become pregnant during therapy with RISPERDAL® CONSTA®.

> Caution should be exercised when RISPERDAL® CONSTA® is

> administered to a nursing woman.

>

> RISPERDAL® CONSTA® may make you more sensitive to heat. You may

> have trouble cooling off, or be more likely to become dehydrated, so

> take care when exercising or when doing things that make you warm.

>

> Some medications interact with RISPERDAL® CONSTA®. Please inform

> your healthcare professional of any medications or supplements that

> you are taking. Avoid alcohol while on RISPERDAL® CONSTA®.

>

> In a study of people taking RISPERDAL® CONSTA®, the most common

> side effects in the treatment of schizophrenia were headache,

> tremors, dizziness, restlessness, tiredness, constipation,

> indigestion, sleepiness, weight gain, pain in the limbs, and dry

> mouth.

>

> If you have any questions about RISPERDAL® CONSTA® or your

> therapy, talk with your doctor.

>

> (This press release contains " forward-looking statements " as defined

> in the Private Securities Litigation Reform Act of 1995. These

> statements are based on current expectations of future events. If

> underlying assumptions prove inaccurate or unknown risks or

> uncertainties materialize, actual results could vary materially from

> J & JPRD's expectations and projections. Risks and uncertainties

> include general industry conditions and competition; economic

> conditions, such as interest rate and currency exchange rate

> fluctuations; technological advances and patents attained by

> competitors; challenges inherent in new product development,

> including obtaining regulatory approvals; domestic and foreign health

> care reforms and governmental laws and regulations; and trends toward

> health care cost containment. A further list and description of these

> risks, uncertainties and other factors can be found in Exhibit 99 of

> & 's Annual Report on Form 10-K for the fiscal year

> ended December 30, 2007. Copies of this Form 10-K, as well as

> subsequent filings, are available online at www.sec.gov, www.jnj.com

> or on request from & . J & JPRD does not undertake to

> update any forward-looking statements as a result of new information

> or future events or developments.)

>

> (1) Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity,

> and comorbidity of twelve-month DSM-IV disorders in the National

> Comorbidity Survey Replication (NCS-R). Archives of General

> Psychiatry, 2005 Jun; 62(6):617-27.

>

> SOURCE & Pharmaceutical Research & Development,

> L.L.C. (J & JPRD)

>

> Source: PR Newswire

>

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>

hmm good drug (not)