Newly added FDA warnings so far in 2010…
Pristiq! That wind-up doll may experience gastrointestinal bleeding, hallucinations, and photosensitivity reactions. Yikes, she just managed to wind herself up a few months ago! I would like to see her with dialated pupils, walking into some walls. I wonder if you can buy a Pristiq doll… I’m guessing not.
Cialis can lead to Steven’s Johnson Syndrome (a disgusting, malignant, life-threatening rash). Not too sexy. Interesting that this is also the reason why many psychiatrists are reluctant to prescribe Lamictal over Epival or Lithium as a “mood stabilizer”… I wonder if they’re as worried about risk when treating patients with “erectile dysfunction syndrome”. I knew one shrink who would absolutely never prescribe Lamictal because he judged it “too risky”. I wonder if he takes Cialis.
Didrex - I didn’t realize there was a new amphetamine on the market! I love how it’s referred to as an anorectic agent. It’s a diet pill. It induces anorexia. Awesome.
- Didrex tablets should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations and herbal products.
- In a case-control epidemiological study, the use of anorectic agents was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. It should be noted that benzphetamine was not specifically studied in this case-control study.
- The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, Didrex tablets should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.
- Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when benzphetamine has been used alone.
- The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of benzphetamine treatment. Didrex tablets are not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with Didrex tablets should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined
by the physician and patient).
- Didrex tablets are not recommended for severely hypertensive patients or for patients with symptomatic cardiovascular disease including arrhythmias.
- Didrex tablets are not recommended for patients who used any anorectic agents within the prior year.
Effexor strikes again? It is now known to cause “angioedema” – a rapid swelling of the skin, subcutaneous tissue, and mucous membranes. That doesn’t look pleasant.
Symbyax!! The Prozac (fluoxetine)/Zyprexa (olanzepine) combo that I love to rant about. I don’t think they even have a TV commercial for this stuff yet… “Prolactin” = a peptide hormone that causes lactation and menstrual irregularities in women, and erectile dysfunction and infertility in men. Better get some Cialis…oh, but the rash thing…meh, worth the risk…
- In controlled clinical studies of Symbyax (up to 12 weeks), changes from normal to high in prolactin concentrations were observed in 28% of adults treated with Symbyax as compared to 5% of placebo-treated patients. Modest elevations persisted throughout administration of SYMBYAX. In a pooled analysis from clinical studies including 2929 adults treated with Symbyax, potentially associated clinical manifestations included menstrual-related events1 (1% [20/1946] of females), sexual function-related events (7% [192/2929] of females and males), and breast-related events (0.8% [16/1946] of females, 0.2% [2/983] of males).
- In placebo-controlled olanzapine clinical studies (up to 12 weeks), changes from normal to high in prolactin concentrations were observed in 30% of adults treated with olanzapine as compared to 10.5% of adults treated with placebo. In a pooled analysis from clinical studies including 8136 adults treated with olanzapine, potentially associated clinical manifestations included menstrual related events (2% [49/3240] of females), sexual function-related events (2% [150/8136] of females and males), and breast-related events (0.7% [23/3240] of females, 0.2% [9/4896] of males).
- In placebo-controlled olanzapine monotherapy studies in adolescent patients (up to 6 weeks) with schizophrenia or bipolar I disorder (manic or mixed episodes), changes from normal to high in prolactin concentrations were observed in 47% of olanzapine treated patients compared to 7% of placebo-treated patients. In a pooled analysis from clinical trials including 454 adolescents treated with olanzapine, potentially associated clinical manifestations included menstrual-related events1 (1% [2/168] of females), sexual function-related events (0.7% [3/454] of females and males), and breast-related events3 (2% [3/168] of females, 2% [7/286] of males
I guess it makes sense to follow that some warnings were added to Zyprexa (Olanzepine) without the Prozac as well (isn’t this Japanese ad for the drug amazing??).
- As with other drugs that antagonize dopamine D2 receptors, olanzapine elevates prolactin levels, and the elevation persists during chronic administration. Hyperprolactinemia may suppress hypothalamic GnRH…
- Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated…
- In placebo-controlled olanzapine clinical studies (up to 12 weeks), changes from normal to high in prolactin concentrations were observed in 30% of adults treated with olanzapine as compared to 10.5% of adults…
- In placebo-controlled olanzapine monotherapy studies in adolescent patients (up to 6 weeks) with schizophrenia or bipolar I disorder (manic or mixed episodes), changes from normal to high in prolactin concentrations…
Clozaril (Clozapine), you have a hard time don’t you? Now you’re also prone to causing an increased risk of “cerebrovascular events” in patients at risk for stroke?
This statement, right out of the camel’s mouth, I do not understand…”Pharmacokinetic-Related Interactions: Concomitant administration of drugs known to induce cytochrome P450 enzymes may decrease
the plasma levels of clozapine…tobacco smoke”
…tobacco smoke???? Does this mean I shouldn’t have been smoking while I was on Clozapine?
Three more for good measure:
- Central Nervous System: obsessive compulsive symptoms
- Metabolic and Nutritional Disorders: new onset diabetes
- Respiratory System: pneumonia and lower respiratory tract infection which may be fatal
Viagra - (and yes, that’s a real ad) don’t worry, Cialis, Viagra’s getting a new label too. Here’s the statement released, which speaks to the amount of drugs people are on these days…good god:
“Physicians should inform patients not to take Viagra with other PDE5 inhibitors including Revatio. Sildenafil is also marketed as Revatio for the treatment of pulmonary arterial hypertension. The safety and efficacy of Viagra with other PDE5 inhibitors, including Revatio, have not been studied.”
well, that’s all for the past 2 months…let’s see what March’s FDA review has to say in a few short days!