Zithromax warning

The FDA has issued a warning for the use of azithromycin, an antibiotic sold under the brand name Zithromax. The agency warns that the drug may cause an irregular heart rhythm, potentially fatal in nature, in people with pre-existing risk factors, including QT prolongation, low blood potassium or magnesium, a slow heart rate, and arrythmia treated with medication.

Statins get FDA warning label

Statins, popular drugs used to lower cholesterol, will be sporting a new FDA warning label. The drugs have been associated with increased blood sugar levels, which could lead to or exacerbate type 2 diabetes. They are also associated with confusion and memory loss in some patients.These drugs include Crestor, Lipitor and Zocor.

Statins have had some controversy since their approval due to questionable use in women and men with no history of heart disease. Though studies have shown repeatedly that the drugs lower cholesterol in men with previous heart disease and reduce the chance of a second heart attack, they have not been definitively linked to the same success in women or men with no established heart disease, despite news reports to the contrary. One meta-analysis in January 2012 combined women's data from various studies (they generally don't enroll enough women to test for an effect in a single study) found a benefit, but this still isn't proof, as pointed out by the authors of that study!

Menopause

Another uniquely female health concern is menopause. Women are capable of conceiving children because of both the reproductive organs in their lower abdomen and the hormones the ovaries and adrenals produce. Estrogen and progesterone cycle, causing the release of an egg, its maturation, and if sperm is present and infiltrates the egg - implantation of the zygote to mature as an embryo, fetus, and child. When the egg is not fertilized, the hormones cause the uterine lining to be refreshed in case there is a zygote to nourish during the next cycle. This menstrual cycle repeats itself monthly (approximately 28 days, but this varies by woman and her natural hormonal rhythm, which changes with age as well) from puberty to middle age.

Like the rest of the body, the ovaries age and the decreased estrogen in the body results in a cessation of the menstrual cycle around the age of 50 (earlier or later, varies by woman), known as menopause. This hormonal change also causes symptoms - hot flashes being the most stereotypical, though many women don't have symptoms. Hormonal replacement therapy (estrogen pills) were used as a way to treat these symptoms, but it was found to have unplanned cardiovascular risks. Similar to hormonal birth control, synthetic and combination therapies were tested to reduce the side effects while keeping options open for women. Prempro is one such treatment. However, anyone opting to take Prempro should discuss the potential adverse effects with their doctor

Prempro is a combination hormonal therapy used to treat symptoms of menopause, such as hot flashes. The pill contains conjugate estrogens and medroxyprogesterone acetate. Estrogen used alone was found to increase the risks of uterine cancer, dementia, strokes, and blood clots. Progestins (like progesterone) were added to reduce these risks, but the combination treatment has its own adverse effects, such as an increased risk of breast cancer.

The Women's Health Initiative was a 15-year program that investigated the most common causes of death and disease in postmenopausal women. The study included an evaluation of hormone therapy in 60,000 women. The estrogen plus progestin substudy was halted early, after a little more than 5 years, due to the risks outweighing the benefits. Women treated with the combination therapy in the study had increased risk of heart attack, stroke, venous thrombosis, and blood clots.

Breast and lung cancer risks are also increased by Prempro use. As reported in USA Today in October 2010, a study comparing Prempro use to placebo found an increased risk of breast cancer, and an increased risk of that cancer’s spread to the lymph nodes (metastasis). Women taking the drug were also more likely to die from breast cancer. A previous study that year had found an increased risk of death from lung cancer, though it did not increase the risk of lung cancer per se.

A positive side effect though is a decreased colorectal cancer risk in those who are treated. In addition, stopping treatment results in normal breast cancer risk within 2 years of stopping.

The FDA also warns of potential increased risk of dementia with Prempro use in women aged 65 years and older. The exact combination in the Prempro pill was not studied in the Women’s Health Initiative substudies (cardiovascular and dementia risks), but the FDA assumes, in the absence of that specific data, that the estrogen plus progestin study findings are applicable to estrogen plus medroxyprogesterone.

In addition, Pfizer's label includes the following side effects: high blood pressure, liver problems, depression, increased benign fibroid size in the uterus, high blood sugar, benign breast lumps and breast discomfort, unusual vaginal bleeding and spotting, fatigue and dizziness, severe headaches, chest pain, changes in vision and speech, leg pain, shortness of breath, fluid retention and bloating, vaginal dryness and yeast infection, hair loss, stomach pain, and headaches, sometimes severe.

The discomfort of menopause will subside on its own once the hormones become regulated, usually over the course of a year or two, though the symptoms may recur for up to 5 years. Women with severe symptoms may find relief in treatment, though they may have their own side effects to consider.

Changes for Children's Cold Meds

The drug companies are voluntarily adding warning labels to children's cold medications [broken link]. Bowing to pressure from pediatricians and doing what the FDA refuses to, the companies are advising parents to not give cold medications to children under the age of 4.

Parents should:

• Never give adult medications to the child.

• Never give antihistamines to help a child sleep.

• Never give more than one medication that contain the same ingredients (acetaminophen and antihistamines are the worse offenders).

• Speak to their doctor about potential treatments or medications.

• Follow directions and warning labels exactly.

• Keep all medication, over-the-counter and prescription, out of reach and out of sight of children.