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October 7, 2006

Paxil CR Recalled, Patients Not Informed

Last month, GlaxoSmithKline recalled Paxil CR pills that were lacking the active ingredient paroxetine hydrochloride. They recalled 7.5 million pills but did not inform patients.

Doctors said the lack of a warning could mean that patients may face a sudden withdrawal that can spur suicidal thoughts, shooting pain and flu-like symptoms. The Paxil CR pills Glaxo recalled can cause severe withdrawal symptoms, said Stephen Ellen of the University of Massachusetts Medical School.

Peter Lurie of advocacy group Public Citizen said: "To the extent patients learn of it, they're likely to return distributed inventory and that's going to cost the company money. This way the company gets to say they did a recall, they dump the responsibility on intermediaries, and the patient most likely hears nothing."

Glaxo didn't tell of Paxil recall

Posted by Staff at 8:45 PM | Comments (24)

September 29, 2006

Paxil Side Effects

Paxil (paroxetine hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) antidepressant marketed by GlaxoSmithKline.

Paxil is approved to treat depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), generalized anxiety disorder, social anxiety disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

It has been used off-label to treat bipolar disorder, chronic headache, hot flashes, compulsive gambling, and diabetic neuropathy.

Paxil CR is the controlled release verson of Paxil, meaning it is released slowly into the body for continuous effect.

According to the official Paxil website, common side effects may include nausea, infection, diarrhea, dry mouth, injury, constipation, sleepiness, increased appetite, sexual side effects, tremor, nervousness, yawning, sweating, weakness, abnormal vision, or insomnia.

More serious side effects may include suicidal thoughts, worsening depression, or severe changes in mood or behavior.

This space is provided for you to share your side effects (or lack thereof) and experiences with Paxil and Paxil CR by posting a comment below.

Posted by Staff at 7:56 PM | Comments (4)

September 29, 2006

Lamictal and Cleft Palate Birth Defects

The FDA has issued a warning that Lamictal, a GlaxoSmithKline drug prescribed for bipolar disorder and epilepsy, has been linked to birth defects when taken by women in the first three months of pregnancy.

In a registry of 564 pregnant women who took the drug during the first trimester, five gave birth to babies with a cleft lip or cleft palate, which is a gap in the upper lip or roof of the mouth. The agency advises women taking Lamictal who are pregnant or thinking of becoming pregnant to speak with their doctor.

Glaxo Bipolar Drug May Be Tied to Defect

Related: bipolar disorder, epilepsy

Posted by Staff at 1:56 PM | Comments (1)

September 25, 2006

Lamictal Approved for Tonic Clonic Seizures

GlaxoSmithKline's Lamictal was given the FDA greenlight to treat Primary Generalized Tonic-Clonic (PGTC) seizures in adults and children two and older.

This is the fifth FDA approval for Lamictal, which has also been approved to treat partial and generalized seizures and can be used as maintenance therapy for adults with bipolar I disorder.

GlaxoSmithKline says FDA OKs new indication for epilepsy drug

Posted by Staff at 6:47 PM | Comments (0)

September 19, 2006

Wellbutrin Side Effects

Wellbutrin (Bupropion) is an antidepressant of the aminoketone class marketed by GlaxoSmithKline. Zyban, also marketed by GlaxoSmithKline, has the same chemical properties but is marketed as a smoking cessation aid. These drugs are dopamine reuptake inhibitors and norepinephrine reuptake inhibitors. Bupropion has also been used or is being studied to treat other disorders, including bipolar disorder, ADHD, restless legs syndrome, and obesity.

Wellbutrin XL is the extended release formulation and is taken orally once per day. Wellbutrin SR is a sustained-release formula and is taken twice per day.

This space is provided for you to share your side effects (or lack thereof) and experiences with Wellbutrin by posting a comment below.

Posted by Staff at 2:14 PM | Comments (475)

August 25, 2006

FDA Orders Label Changes for Dexedrine

The FDA has asked pharmaceutical company GlaxoSmithKline to add a warning to ADHD drug Dexedrine alerting patients to possible risk of heart problems when taking the drug.

The warning describes some instances of sudden death in children and teens with structural cardiac abnormalities or other heart problems. It also mentions various potential psychological side effects, including hallucinations or delusional thinking.

ADHD Drug to Get Stronger Warning

Cardiovascular Safety Warning Added for Stimulants for ADHD

Posted by Staff at 1:25 AM | Comments (0)


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