16 Drugs on the FDA Watch List
http://www.medscape.com/viewarticle/762205
Acne Medication
Use of isotretinoin (Roaccutane, formerly known as Accutane) to treat severe acne was linked to a two-fold risk of developing eye problems, such as pink eye, styes and dryness. Isotretinoin is known to have serious side effects, such as bone growth delays in teenagers and miscarriages and birth defects when taken by pregnant women.
The new Archives of Dermatology study found that of nearly 15,000 Israeli adolescents and young adults, 14% of those taking isotretinoin were treated for eye conditions within a year of starting the drug, compared to 7% of an acne-free comparison group.
Blood Pressure Medication
Aliskiren-containing medications are renin inhibitors used to treat high blood pressure (hypertension). They go by the names:
Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
Tekturna (aliskiren hemifumarate)
Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
Tekamlo (aliskiren hemifumarate and amlodipine besylate)
Valturna (aliskiren hemifumarate and valsartan).
FDA notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment.
Bone Loss Medication
Patients taking oral bisphosphonates for the first time may be at higher risk of developing scleritis and uveitis (eye diseases), according to an April 2 study in Canadian Medical Association Journal.
The incidence rate among 10,827 first-time bisphosphonate users was 29/10,000 person-years for uveitis and 63/10,000 person-years for scleritis. In contrast, the incidence rate among 923,320 nonusers was 20/10,000 person-years for uveitis and 36/10,000 for scleritis.
"This is the first study that quantifies the risk of uveitis and scleritis with these drugs. In the past, much attention has been given to other adverse events related to these drugs, mainly linking them to increasing the risk of atypical fractures, atrial fibrillation, and gastrointestinal cancer," the lead author said.
It is possible that the release of inflammatory mediators triggered by the use of bisphosphonates may be the mechanism behind the development of scleritis and uveitis among first-time users. Left untreated, uveitis can lead to cataracts, glaucoma, macular edema, and scleral perforation.
Hair Loss Medication
Two Merck & Co. drugs, one to treat hair loss in men (Propecia), the other to treat an enlarged prostate gland (Proscar), will get revised labels warning of potential sexual side effects that can last even after patients stop taking the drugs. Both drugs share the same chemical compound, called finasteride.
The new Propecia label will include a warning of "libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug," the FDA said in a recent news release.The Proscar label will include a warning about "decreased libido that continued after discontinuation of the drug," the agency said. The labels of both drugs will also carry about a description of reports of male infertility and/or poor semen quality that clears up or improves after the drugs are stopped.
Statins
Statins were responsible for rhabdomyolysis (muscle breakdown) in 7.5% of patients diagnosed with the skeletal muscle condition, according to a review of International Classification of Disease, Ninth Edition (ICD-9) codes. Publishing their findings as a letter to the editor in the Journal of the American Medical Association, reseacrhers also confirmed a significantly higher risk of rhabdomyolysis in patients treated with high doses of simvastatin.
In a separate warning from the FDA, taking Statins With HIV or Hepatitis C Drugs raises muscle injury risk
Weight-Loss Medication
Orlistat is an inhibitor of gastric and pancreatic lipase with proven efficacy in the augmentation and maintenance of weight loss. Although its use has been limited by troublesome but benign gastrointestinal side effects, it has more recently been associated with acute kidney injury (AKI). In a Therapeutic Advances in Drug Research review, although the author's cannot yet draw an unequivocal causal link between orlistat and AKI, there is enough evidence to include orlistat exposure in the clinical assessment of patients with AKI.
MedWatch's Most Recent Safety Page
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300978.htm?source=govdelivery
http://www.medscape.com/viewarticle/762205
Acne Medication
Use of isotretinoin (Roaccutane, formerly known as Accutane) to treat severe acne was linked to a two-fold risk of developing eye problems, such as pink eye, styes and dryness. Isotretinoin is known to have serious side effects, such as bone growth delays in teenagers and miscarriages and birth defects when taken by pregnant women.
The new Archives of Dermatology study found that of nearly 15,000 Israeli adolescents and young adults, 14% of those taking isotretinoin were treated for eye conditions within a year of starting the drug, compared to 7% of an acne-free comparison group.
Blood Pressure Medication
Aliskiren-containing medications are renin inhibitors used to treat high blood pressure (hypertension). They go by the names:
Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
Tekturna (aliskiren hemifumarate)
Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
Tekamlo (aliskiren hemifumarate and amlodipine besylate)
Valturna (aliskiren hemifumarate and valsartan).
FDA notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment.
Bone Loss Medication
Patients taking oral bisphosphonates for the first time may be at higher risk of developing scleritis and uveitis (eye diseases), according to an April 2 study in Canadian Medical Association Journal.
The incidence rate among 10,827 first-time bisphosphonate users was 29/10,000 person-years for uveitis and 63/10,000 person-years for scleritis. In contrast, the incidence rate among 923,320 nonusers was 20/10,000 person-years for uveitis and 36/10,000 for scleritis.
"This is the first study that quantifies the risk of uveitis and scleritis with these drugs. In the past, much attention has been given to other adverse events related to these drugs, mainly linking them to increasing the risk of atypical fractures, atrial fibrillation, and gastrointestinal cancer," the lead author said.
It is possible that the release of inflammatory mediators triggered by the use of bisphosphonates may be the mechanism behind the development of scleritis and uveitis among first-time users. Left untreated, uveitis can lead to cataracts, glaucoma, macular edema, and scleral perforation.
Hair Loss Medication
Two Merck & Co. drugs, one to treat hair loss in men (Propecia), the other to treat an enlarged prostate gland (Proscar), will get revised labels warning of potential sexual side effects that can last even after patients stop taking the drugs. Both drugs share the same chemical compound, called finasteride.
The new Propecia label will include a warning of "libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug," the FDA said in a recent news release.The Proscar label will include a warning about "decreased libido that continued after discontinuation of the drug," the agency said. The labels of both drugs will also carry about a description of reports of male infertility and/or poor semen quality that clears up or improves after the drugs are stopped.
Statins
Statins were responsible for rhabdomyolysis (muscle breakdown) in 7.5% of patients diagnosed with the skeletal muscle condition, according to a review of International Classification of Disease, Ninth Edition (ICD-9) codes. Publishing their findings as a letter to the editor in the Journal of the American Medical Association, reseacrhers also confirmed a significantly higher risk of rhabdomyolysis in patients treated with high doses of simvastatin.
In a separate warning from the FDA, taking Statins With HIV or Hepatitis C Drugs raises muscle injury risk
Weight-Loss Medication
Orlistat is an inhibitor of gastric and pancreatic lipase with proven efficacy in the augmentation and maintenance of weight loss. Although its use has been limited by troublesome but benign gastrointestinal side effects, it has more recently been associated with acute kidney injury (AKI). In a Therapeutic Advances in Drug Research review, although the author's cannot yet draw an unequivocal causal link between orlistat and AKI, there is enough evidence to include orlistat exposure in the clinical assessment of patients with AKI.
MedWatch's Most Recent Safety Page
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300978.htm?source=govdelivery
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