FEMARA: DOSAGE, SIDE EFFECTS, HISTORY

clomid-letrozoleFemara (letrozole) is an oral, non-steroidal aromatase inhibitor, usually indicated for the treatment of hormonally responsive breast cancer after surgery and radiation. This medication lowers estrogen levels in postmenopausal women, which can slow the growth of certain types of breast tumors. It may be prescribed for women with ovulation problems, or for the ones with unexplained infertility, being used for ovarian stimulation. It also increases pregnancy chances in ovulating women.

FEMARA SIDE EFFECTS

As any other kind of medication, Femara doesn’t devoid of side effects. There is a wide range of unwanted consequences that a woman taking this medication might experience. It can cause general, cardiovascular, musculoskeletal, respiratory, hepatic and gastrointestinal complications, such as higher incidence of birth defects, hot flashes, hair loss, tiredness, yellowing eyes/skin, unusual sweating, nausea, bone fractures, mental/mood changes (depression/ anxiety), persistent vomiting, dark urine, bone and joint pain, fatigue, dizziness, drowsiness, higher cholesterol, hot flashes, weight gain. Less common side effects are: bone fracture, breast pain, shortness of breath, mental depression, swelling of the feet or lower legs, breast pain, flu-like symptoms, swelling of the feet or lower legs. Also, the following adverse reactions might occur: hypercholesterolemia, flushes, arthralgia, arthritis, night sweats, myalgia, edenam weight decrease, vaginal bleeding or irritation, back pain, headache, pain in extremity, anorexiam endometrial hyperplasia, other endometrial disorders, myocardial infraction, insomnia.

This drug might impair your thinking or reactions, so be careful while driving or doing other activity that requires attention. As it applies to your health, consider making a research about what are you allergic to. It is very important because this product may contain inactive ingredients, which can cause allergic reactions or other problems. If you have noticed that any of these effects occur or worsen, notify your doctor or pharmacist promptly.

Note: You should not use Femara if you are allergic to letrozole, or if you have not gone completely through menopause. Keep in mind that your doctor prescribed this drug, according to the assumption that it will cause you more benefit than harm.

INDICATION AND ADMINISTRATION OF FEMARA

Femara belongs to the aromatase inhibitor drug class, indicated for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. The tablets are taken orally without regard to meals, with recommended dose – 2.5 mg once daily.

Femara pillNote: Patients with cirrhosis or severe hepatic impairment must take 2.5 mg every other day (reduced by 50%). Femara 2.5 mg tablets are dark yellow, film-coated, round, slightly biconvex, with beveled edges (imprinted with the letters FV on one side and CG on the other side). Generally, the optimal duration of treatment with letrozole is unidentified, but studies show that the best option is to take this drug for 5 years and discontinue the treatment at relapse. A missed dose should be taken as soon as the patient remembers,and make sure that doses aren’t doubled.

HISTORY of FEMARA on the MARKET

Back in the chronicle of events surrounding Letrozole on the market, we should highlight following steps:

July 25, 1997 FDA (US Food and Drug Administration) approved this drug to treat breast cancer in postmenopausal women. In 1998, the international BIG 1-98 trial discovered Femara advantage compared to Tamoxifen (prescribed after surgery in postmenopausal women diagnosed with hormone-receptor positive, early-stage breast cancer). The results proved that Letrozole was better for increasing the time before the cancer comes back in those who encounter recurrence and for reducing the risk of the cancer advancing to other parts of the body.

In February 2001, Novartis Pharmaceutical received a cautionary letter regarding off-label and false advertising of Femara.

November, 2005 marked the first connection between Femara and birth defects.

On November 29, 2005, a research performed by Canadians proved that 7/150 births occurred after the mother was treated with Femara, were related to birth defects: two examples of cardiac stenosis, two gastrointestinal malformations, three cases of bone malformations.

In April, 2009, Novartis Pharmaceuticals received a warning letter from FDA, mentioning the facts that sponsored links on internet search engines for Femara and other drugs were misleading and that they failed to inform about the risks related to the drug use.

On March 2, 2010, FDA notifies about the fact that Femara decreases bone mineral density. 

December 23, 2011 is the date when safety labeling were modified. Since then, they included carpal tunnel syndrome and trigger finger.

KEEP IN MIND THAT…

Femara letrozoleThe existing contraindications involve: hypersensitivity to the active substance, premenopausal endocrine status, unclear menopausal status, renal or hepatic impairment, pregnancy, breast-feeding. It has to be mentioned that sometimes doctors make a huge mistake, prescribing a medication “off-use”, generating serious health damages. The same situation happened to Femara, the most lawsuits being associated with the following charges:

  • Higher Incidents of Birth Defects;
  • Significant risk of developing osteoporosis (particularly, for the patients with a longer treatment period. It has to be mentioned that patients must be warned about the possibility of cholesterol level growth as a result of treatment);
  • Lowered bone mineral density (BMD). Consequently, consideration should be given to monitoring BMD.

Health injury is a serious offense and you need a qualified attorney in order to win the case. If you, or your loved experienced damaging Femara side effects, don’t hesitate to ask for legal help. All you have to do is access Legal Bistro, create an account and describe your case. 

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