FYI - Prolia - FDA Warnings(Osteoporosis, Bisphosphonate Drug)
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Prolia - FDA Warningshttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformati
"Important Information about the Risks of Prolia
The FDA has approved Prolia with a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of the drug outweigh the risks of:
 serious infections,
 dermatologic adverse events and
 suppression of bone turnover.
In a clinical trial of over 7800 women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the Prolia group than in the placebo group. Serious infections including skin infections and endocarditis, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia.
Dermatologic adverse events
Epidermal and dermal adverse events such as dermatitis, eczema and rashes occurred at a significantly higher rate in the Prolia group (10.8%) compared to the placebo group (8.2%).Suppression of bone turnover
(including osteonecrosis of the jaw (ONJ) and fracture healing complications)Prolia results in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry
. The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as ONJ, atypical fractures and delayed fracture healing
. ONJ has been reported in the osteoporosis clinical trial in patients receiving denosumab.Introduction of Prolia Post-marketing Active Safety Surveillance Program
To monitor the long-term safety of Prolia, Amgen will be soliciting adverse event reporting of 9 pre-specified adverse events of special interest (AESI) including serious infections, dermatologic adverse events and suppression of bone turnover
. Data collection will include an AESI soliciting questionnaire and AESI-specific questionnaire. Prolia prescribers are invited to
Reference ID: 3128819MEDICATION GUIDE ProliaŽ (PRÓ-lee-a) (denosumab)
Injection, for subcutaneous use
Read the Medication Guide that comes with Prolia before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about Prolia.
What is the most important information I should know about Prolia?If you receive Prolia, you should not receive XGEVAŽ . Prolia contains the same medicine as Xgeva (denosumab).
Prolia can cause serious side effects including
1. Low calcium levels in your blood (hypocalcemia).
Prolia may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Prolia, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
 Spasms, twitches, or cramps in your muscles
 Numbness or tingling in your fingers, toes, or around your mouth
Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Prolia. Take calcium and vitamin D as your doctor tells you to.
2. Serious infections.
Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take Prolia. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Prolia. You may need to go to the hospital for treatment if you develop an infection.Prolia is a medicine that may affect your immune system. People who have weakened immune system or take medicines that affect the immune system may have an increased risk for developing serious infections
Call your doctor right away if you have any of the following symptoms of
 Fever or chills
 Skin that looks red or swollen and is hot or tender to touch
 Severe abdominal pain
 Frequent or urgent need to urinate or burning feeling when you urinate
Reference ID: 3128819
3. Skin problems.
Skin problems such as inflammation of your skin (dermatitis), rash, and eczema may happen if you take Prolia. Call your doctor if you have any of the following symptoms of skin problems that do not go away or get worse:
 Small bumps or patches (rash)
 Your skin is dry or feels like leather
 Blisters that ooze or become crusty
 Skin peeling
4. Severe jaw bone problems (osteonecrosis).
Severe jaw bone problems may happen when you take Prolia. Your doctor should examine your mouth before you start Prolia. Your doctor may tell you to see your dentist before you start Prolia. It is important for you to practice good mouth care during treatment with Prolia.
Call your doctor right away if you have any of these side effects."