Osteo Vegan Program - 30 day - OsteoV SC [Discontinued] by NuMedica

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). Although there has been interest in using oral black pepper for allergic rhinitis, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Asthma. Although there has been interest in using oral black pepper for asthma, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Athletic performance. Oral black pepper has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical trial in untrained males shows that taking a supplement containing black pepper extract 10 mg, caffeine 400 mg, capsicum extract 66.7 mg, and niacin 40 mg as a single dose prior to exercise does not improve strength, time to exhaustion, or maximal oxygen consumption when compared with placebo (37873).
• Depression. Although there has been interest in using oral black pepper for depression, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Diarrhea. Although there has been interest in using oral black pepper for diarrhea, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Dysmenorrhea. Although there has been interest in using oral black pepper for dysmenorrhea, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Dyspepsia. Although there has been interest in using oral black pepper for dyspepsia, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Fall prevention. It is unclear if inhaling black pepper oil as aromatherapy is beneficial for fall prevention in older adults. Details: One small clinical study in older adults shows that applying black pepper oil near the right side of the nose as an olfactory stimulant improves stability while the eyes are closed during a one-minute trial when compared with the application of water. The improvement with black pepper oil is comparable to the improvement seen with the application of lavender oil (29160). It is unclear if any benefit persists after inhalation of black pepper oil.
• Fatigue. It is unclear if oral black pepper is beneficial in patients with fatigue. Details: One small clinical trial in adults with below-average energy levels shows that taking black pepper 2 grams as a single dose does not improve sustained attention, motivation to perform cognitive tasks, or feelings of mental energy and mental fatigue when compared with placebo (91731).
• Flatulence. Although there has been interest in using oral black pepper for flatulence, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Headache. Although there has been interest in using oral black pepper for headache, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Insect bite. Topical black pepper has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical trial shows that applying a specific product (Trikatu) containing black pepper, long pepper, and ginger, as well as camphor, eucalyptus oil, and menthol, directly to mosquito bites does not reduce papule size, erythema, edema, or pruritis when compared with a control compound containing the same base ingredients but without the pepper and ginger components (89893).
• Obesity. Although there has been interest in using oral black pepper for obesity, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Pain (chronic). Although there has been interest in using topical black pepper for chronic pain related to various etiologies, including osteoarthritis, postherpetic neuralgia, and peripheral neuropathy, there is insufficient reliable information about the clinical effects of black pepper for these conditions.
• Rhinosinusitis. Although there has been interest in using oral black pepper for rhinosinusitis, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Sexual desire. Although there has been interest in using oral black pepper for increasing sexual desire, there is insufficient reliable information about the clinical effects of black pepper for this purpose.
• Smoking cessation. It is unclear if inhaling black pepper essential oil as aromatherapy is effective for smoking cessation. Details: One small clinical trial in adult male smokers who were deprived from smoking overnight shows that inhaling a vapor from the essential oil of black pepper, as needed over a 3-hour period, reduces cigarette cravings, negative feelings, and anxiety when compared with a placebo vapor (29159). Another small clinical study in patients addicted to dipping, chewing, or smoking tobacco shows that placing a drop of black pepper essential oil on tissue paper and inhaling for 2 minutes at least three times a day for 3 days reduces nicotine cravings when compared to baseline (90502).
• Swallowing dysfunction. It is unclear if inhaling black pepper oil as aromatherapy is beneficial in patients with swallowing dysfunction. Details: One small clinical study in post-stroke residents of nursing homes shows that one minute of olfactory stimulation with black pepper oil before each meal for 30 days decreases swallowing reflex latency by 11 seconds and increases the number of swallowing movements by 3.3 when compared to baseline (29161). A small clinical trial in children with neurological disorders who were on long-term enteral nutrition shows that applying black pepper oil to the nostrils or nasal cavity for one minute improves the amount of oral intake and swallowing movement in 63% of patients. Although oral intake increased, the need for enteral nutrition was not eliminated (29162).
• Vitiligo. It is unclear if topical piperine oil, a constituent of black pepper, is beneficial in patients with vitiligo. Details: A small clinical study in patients with vitiligo shows that applying piperine oil 1% daily in addition to receiving narrowband ultraviolet B (NB-UVB) light therapy every other day for 3 months improves repigmentation more rapidly when compared with using NB-UVB alone (103820). More evidence is needed to rate black pepper for these uses.

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EFFECTIVE

• Dental hypersensitivity. Brushing with strontium-containing toothpaste improves dental hypersensitivity. Details: Several clinical studies show that topical use of strontium acetate 8% and strontium chloride 10% in toothpaste relieves the pain of sensitive teeth (11745,11746,32177,76519,76570,76590). Best results are obtained with twice daily brushing (11756,32177,76590).
• Painful bony metastases. Intravenous strontium-89 improves pain associated with bony metastases. Details: Several clinical studies show that intravenous administration of strontium-89 chloride reduces metastatic bone pain (11749,11750,11751,11752,76608).

LIKELY EFFECTIVE

• Osteoporosis. Oral strontium ranelate seems to increase bone mineral density (BMD) and reduce fracture risk to a clinically significant degree in females and males with osteoporosis; however, safety concerns limit its use. Details: Several clinical studies and a meta-analysis in postmenopausal individuals with osteoporosis show that taking strontium ranelate reduces the risk of vertebral fractures by around 40% in patients with a history of vertebral fracture. There is some evidence that it might increase BMD in these patients by 14% at the lumbar spine and 8% at the femoral neck. Taking strontium ranelate also appears to reduce the risk of nonvertebral fractures by 31% (11392,11393,11395,76597,94010). In patients with or without a history of vertebral fracture, taking strontium ranelate for up to 10 years also reduces the risk of nonvertebral fractures by 15% to 38% and vertebral fractures by 24% to 35%. BMD at the lumbar spine, femoral neck, and total hip also continues to increase over the first 5 years of treatment (76527,76562,94012). In postmenopausal individuals over the age of 80 years, taking strontium ranelate 2 grams daily for 4 years reduces the relative risk of vertebral fractures by 31%, nonvertebral fractures by 33%, major nonvertebral fractures by 27%, and hip fractures by 24% when compared with placebo (94011). A large clinical trial in males with osteoporosis also shows that taking strontium ranelate 2 grams daily for 2 years significantly increases lumbar spine, femoral neck, and total hip BMD when compared with placebo (94002). There is conflicting evidence about the efficacy of strontium ranelate in patients previously treated with bisphosphonates. A moderate sized clinical study in postmenopausal individuals with osteoporosis suggests that prior treatment with bisphosphonate therapy might blunt the BMD response in patients taking strontium ranelate 2 grams daily for 2 years. In bisphosphonate naïve patients, treatment with strontium lead to increases in BMD at the spine, hip, and heel. In patients with prior bisphosphonate therapy, treatment with strontium lead to increases in BMD at the spine and hip, but not the heel. (94009). Based on the benefits of strontium ranelate on BMD and fracture risk, it was approved in Europe in 2004 for the treatment of severe osteoporosis in postmenopausal patients, and later granted market authorization for males with osteoporosis. However, its use is associated with cardiac events and thromboembolism; it is therefore contraindicated in patients with a history or risk of venous thromboembolism, uncontrolled hypertension, ischemic heart disease, peripheral heart disease, and/or cerebrovascular disease. Because of its limited use in patients with osteoporosis, the manufacturers of prescription strontium ranelate (Protelos) discontinued its manufacturing in August 2017 (95698). Strontium ranelate is not approved for use in the US.

POSSIBLY EFFECTIVE

• Osteoarthritis. Large clinical trials suggest that oral strontium ranelate is beneficial for the prevention of spinal osteoarthritis progression and the treatment of knee osteoarthritis. Details: Analysis of data from two large clinical trials in postmenopausal individuals with a history of vertebral fracture shows that taking strontium ranelate daily for 3 years appears to improve back pain and reduce the risk of spinal osteoarthritis progression by 42% when compared with placebo (76558). Additionally, two large clinical trials in patients with knee osteoarthritis show that taking strontium ranelate 1-2 grams daily for 3 years reduces joint space narrowing by 0.1-0.14 mm, improves overall symptoms and pain symptoms, and may improve stiffness and physical function when compared with placebo (94006,94007). The dose of 2 grams daily seems to be more effective than a lower dose of 1 gram daily (94007,94008).
• Prostate cancer. Some clinical research suggests that intravenous strontium-89 chloride slows the progression of prostate cancer. Details: Two clinical trials show that intravenous administration of strontium-89 chloride seems to slow the progression of treatment-resistant prostate cancer and to relieve pain associated with prostate cancer (11747,11748). However, it appears to be less effective when compared with local radiation therapy (111748).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. Although there has been interest in using oral strontium for metastatic cancer, there is insufficient reliable information about the clinical effects of strontium for this purpose.
• Dental caries. Although there has been interest in using oral strontium for the prevention of dental caries, there is insufficient reliable information about the clinical effects of strontium for this purpose.
• Fractures. It is unclear if oral strontium is beneficial in patients with wrist fractures. Details: A small clinical study in patients over 60 years of age with a wrist fracture shows that taking strontium ranelate 2 grams daily for 3 months, in addition to calcium and vitamin D, does not improve or accelerate wrist fracture healing when compared with calcium and vitamin D alone (94005).
• Pruritus. It is unclear if topical strontium is beneficial for the prevention of pruritus. Details: A small clinical study in healthy individuals shows that topical application of strontium chloride 4% gel (TriCalm, Cosmederm Bioscience) 15 minutes prior to itch induction with cowhage reduces itch intensity and duration when compared with placebo. It also seems to decrease itch intensity more than topical hydrocortisone 1% or diphenhydramine 2% (94004). More evidence is needed to rate strontium for these uses.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Black pepper has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when black pepper oil is applied topically. Black pepper oil is nonirritating to the skin and is generally well tolerated (11). ...when black pepper oil is inhaled through the nose or as a vapor through the mouth, short-term. Black pepper oil as a vapor or as an olfactory stimulant has been used with apparent safety in clinical studies for up to 3 days and 30 days, respectively (29159,29160,29161,90502). There is insufficient reliable information available about the safety of black pepper when used orally in medicinal amounts.

CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods (11).

CHILDREN: POSSIBLY UNSAFE
when used orally in large amounts. Fatal cases of pepper aspiration have been reported in some patients (5619,5620). There is insufficient reliable information available about the safety of topical pepper oil when used in children.

PREGNANCY: LIKELY SAFE
when used orally in amounts commonly found in foods (11).

PREGNANCY: LIKELY UNSAFE
when used orally in large amounts. Black pepper might have abortifacient effects (11,19); contraindicated. There is insufficient reliable information available about the safety of topical pepper when used during pregnancy.

LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (11). There is insufficient reliable information available about the safety of black pepper when used in medicinal amounts during breast-feeding.

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LIKELY SAFE ...when consumed orally in food amounts. Strontium has not been linked to toxicity when consumed in dietary amounts, which are typically about 0.5-1.5 mg daily (14554,14560). ...when strontium-89 chloride is used intravenously and appropriately. Strontium-89 chloride is an FDA-approved product (4948). ...when strontium chloride is used topically and appropriately as a toothpaste. Strontium chloride hexahydrate (Sensodyne-SC) is an FDA-approved product (9).

POSSIBLY SAFE ...when strontium ranelate is used orally and appropriately. Strontium ranelate 2 grams daily, providing elemental strontium 680 mg daily, seems to be safe when used for up to 10 years (11392,11393,11395,14549,94012).

POSSIBLY UNSAFE ...when used orally in high doses. Very high doses may adversely affect bone structure, although data in humans is limited (11394,11399,14554,14556). Until more is known, advise patients to avoid doses of elemental strontium above 680 mg/day. There is insufficient reliable information available about the safety of strontium chloride, the form most commonly used in dietary supplements, when used orally.

PREGNANCY AND LACTATION: LIKELY SAFE
when consumed orally in food amounts. Strontium has not been linked to toxicity when consumed in dietary amounts, which are typically about 0.5 mg to 1.5 mg/day (14554,14560). ...when strontium chloride is used topically and appropriately as a toothpaste (9). Strontium chloride hexahydrate (Sensodyne-SC) is an FDA approved product.

PREGNANCY AND LACTATION: LIKELY UNSAFE
when strontium-89 chloride is used during pregnancy or lactation. Strontium-89 chloride is a radioactive isotope which may cause fetal harm. It is FDA pregnancy risk category D; avoid using (11755). Since strontium behaves similarly to calcium in the body, strontium-89 is likely to be excreted into breast milk; avoid using during lactation (11755). There is insufficient reliable information about the safety of oral strontium when used in amounts exceeding typical dietary intake during pregnancy or lactation; avoid using.

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AMOXICILLIN (Amoxil, Trimox) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase the effects and side effects of amoxicillin.  Details Animal research shows that taking piperine, a constituent of black pepper, with amoxicillin increases plasma levels of amoxicillin (29269). This has not been reported in humans.

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase the risk of bleeding when taken with antiplatelet or anticoagulant drugs.  Details In vitro research shows that piperine, a constituent of black pepper, seems to inhibit platelet aggregation (29206). This has not been reported in humans.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal research shows that piperine, a constituent of black pepper, can reduce blood glucose levels (29225). Monitor blood glucose levels closely. Dose adjustments might be necessary.

ATORVASTATIN (Lipitor) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase blood levels of atorvastatin.  Details Animal research shows that taking piperine, a constituent of black pepper, 35 mg/kg can increase the maximum serum concentration of atorvastatin three-fold (104188). This has not been reported in humans.

CARBAMAZEPINE (Tegretol) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = B Theoretically, black pepper might increase blood levels of carbamazepine, potentially increasing the effects and side effects of carbamazepine.  Details One clinical study in patients taking carbamazepine 300 mg or 500 mg twice daily shows that taking a single 20 mg dose of purified piperine, a constituent of black pepper, increases carbamazepine levels. Piperine may increase carbamazepine absorption by increasing blood flow to the GI tract, increasing the surface area of the small intestine, or inhibiting cytochrome P450 3A4 (CYP3A4) in the gut wall. Absorption was significantly increased by 7-10 mcg/mL/hour. The time to eliminate carbamazepine was also increased by 4-8 hours. Although carbamazepine levels were increased, this did not appear to increase side effects (16833). In vitro research also shows that piperine can increase carbamazepine levels by 11% in a time-dependent manner (103819).

CYCLOSPORINE (Neoral, Sandimmune) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase the effects and side effects of cyclosporine.  Details In vitro research shows that piperine, a constituent of black pepper, increases the bioavailability of cyclosporine (29282). This has not been reported in humans.

CYTOCHROME P450 1A1 (CYP1A1) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase levels of drugs metabolized by CYP1A1.  Details In vitro research suggests that piperine, a constituent of black pepper, inhibits CYP1A1 (29213). This has not been reported in humans.

CYTOCHROME P450 2B1 (CYP2B1) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase levels of drugs metabolized by CYP2B1.  Details In vitro research suggests that piperine, a constituent of black pepper, inhibits CYP2B1 (29332). This has not been reported in humans.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase levels of drugs metabolized by CYP2D6.  Details In vitro research suggests that some constituents of black pepper inhibit CYP2D6 (29207,29212,38375). This has not been reported in humans.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase levels of drugs metabolized by CYP3A4.  Details In vitro research shows that piperine, a constituent of black pepper, as well as the pepper fruit seem to inhibit CYP3A4 (14375,29212). This has not been reported in humans.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, black pepper might increase blood levels of lithium due to its diuretic effects. The dose of lithium might need to be reduced.  Details Black pepper is thought to have diuretic properties (11).

NEVIRAPINE (Viramune) Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Probable •  Level of Evidence = D Black pepper might increase blood levels of nevirapine.  Details Clinical research shows that piperine, a constituent of black pepper, increases the plasma concentration of nevirapine. However, no adverse effects were observed in this study (29209).

P-GLYCOPROTEIN SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase levels of P-glycoprotein substrates.  Details In vitro research shows that piperine, a constituent of black pepper, seems to inhibit P-glycoprotein (14375,29281,29283).

PENTOBARBITAL (Nembutal) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, black pepper might increase the sedative effects of pentobarbital.  Details Animal research shows that piperine, a constituent of black pepper, increases pentobarbital-induced sleeping time (29214).

PHENYTOIN (Dilantin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Black pepper might increase blood levels of phenytoin.  Details Clinical research shows that piperine, a constituent of black pepper, seems to increase absorption, slow elimination, and increase levels of phenytoin (537,14442). Taking a single dose of black pepper 1 gram along with phenytoin seems to double the serum concentration of phenytoin (14375). Consuming a soup with black pepper providing piperine 44 mg/200 mL of soup along with phenytoin also seems to increase phenytoin levels when compared with consuming the same soup without black pepper (14442).

PROPRANOLOL (Inderal) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Black pepper might increase blood levels of propranolol.  Details Clinical research shows that piperine, a constituent of black pepper, seems to increase absorption and slow elimination of propranolol (538).

RIFAMPIN (Rifadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Black pepper might increase blood levels of rifampin.  Details Clinical research shows that piperine, a constituent of black pepper, seems to increase absorption and serum levels of rifampin (14375,29284).

THEOPHYLLINE Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Black pepper might increase blood levels of theophylline.  Details Clinical research shows that piperine, a constituent of black pepper, seems to increase absorption and slow elimination of theophylline (538).

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ANDROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, androgens might reduce the excretion of strontium, potentially increasing its effects and adverse effects.  Details A small clinical study suggests that treatment with androgens such as testosterone, nandrolone, oxandrolone, and oxymetholone for 5-6 weeks might decrease urinary strontium excretion (11405). The clinical significance of this interaction is unknown.

ANTACIDS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = C Antacids can reduce the absorption of strontium, potentially decreasing its effectiveness.  Details Aluminum hydroxide and magnesium hydroxide can reduce absorption of strontium ranelate by 20% to 25%. Calcium can reduce its absorption to 60% to 70%. Avoid taking antacids within 2 hours of a dose of strontium ranelate (14549,25056). This interaction has also been reported with orally-administered radioactive strontium-85 (14554). It will likely also occur with other forms of strontium.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, estrogens might reduce the excretion of strontium, potentially increasing its effects and adverse effects.  Details A small clinical study suggests that treatment with estrogens for 5-6 weeks might decrease urinary strontium excretion (11405). The clinical significance of this interaction is unknown.

QUINOLONE ANTIBIOTICS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, strontium might decrease the absorption of quinolone antibiotics.  Details Strontium is a divalent cation with similar properties to calcium. It is likely to form complexes with quinolones in the gastrointestinal (GI) tract, preventing absorption of the antibiotic (14549). Recommend taking strontium supplements at least 2 hours before or after quinolones to avoid an interaction.

TETRACYCLINE ANTIBIOTICS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, strontium might decrease the absorption of tetracycline antibiotics.  Details Strontium is a divalent cation with similar properties to calcium. It is likely to form complexes with tetracyclines in the gastrointestinal (GI) tract, preventing absorption of the antibiotic (14549). Recommend taking strontium supplements at least 2 hours before or after tetracyclines to avoid an interaction.

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General ...Orally, black pepper seems to be well tolerated when used in the amounts found in food or when taken as a medicine as a single dose. Topically and as aromatherapy, black pepper oil seems to be well tolerated.
Most Common Adverse Effects:
Orally: Burning aftertaste, dyspepsia, and reduced taste perception.
Inhalation: Cough.
Serious Adverse Effects (Rare):
Orally: Allergic reaction in sensitive individuals.

Gastrointestinal ...Orally, black pepper can cause a burning aftertaste (5619) and dyspepsia (38061). Single and repeated application of piperine, the active constituent in black pepper, to the tongue and oral cavity can decrease taste perception (29267). By intragastric route, black pepper 1.5 grams has been reported to cause gastrointestinal microbleeds (29164). It is not clear if such an effect would occur with oral administration.

Immunologic ...In one case report, a 17-month-old male developed hives, red eyes, facial swelling, and a severe cough following consumption of a sauce containing multiple ingredients. Allergen skin tests were positive to both black pepper and cayenne, which were found in the sauce (93947).

Ocular/Otic ...Topically, ground black pepper can cause redness of the eyes and swelling of the eyelids (5619).

Pulmonary/Respiratory ...When inhaled through the nose as an olfactory stimulant, black pepper oil has been reported to cause cough in one clinical trial (29162).

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General ...Orally, strontium ranelate seems to be well tolerated when used in doses up to 2 grams (680 mg elemental strontium) daily, long-term.
Most Common Adverse Effects:
Orally: Atopic dermatitis, diarrhea, headache, nausea.
Serious Adverse Effects (Rare):
Orally: Myocardial infarction, osteomalacia, venous thromboembolism.

Cardiovascular ...Orally, clinical research shows that strontium ranelate increases the relative risk of venous thromboembolism and pulmonary embolism by about 50% compared with placebo (14561,14562). The reason for this is unknown. Strontium ranelate also seems to increase the risk of myocardial infarction by about 1.6-fold in patients with osteoporosis (95699).

Dermatologic ...Orally, common side effects of strontium ranelate can include dermatitis and eczema (11392,11393,11395,14549).

Gastrointestinal ...Orally, strontium ranelate can cause stomach pain, diarrhea, and nausea, particularly at higher doses (14561,76541,94010,94012).

Hematologic ...Intravenously, strontium-89 causes bone marrow toxicity, particularly affecting platelet and white blood cell counts. Platelet levels fall by about 30% and the nadir is generally 12 to 16 weeks after injection. The effect on white blood cells is variable. Blood cell counts generally recover slowly over a period of about 6 months (11752,11755).

Musculoskeletal ...There is some concern that doses of strontium higher than those used in clinical trials may adversely affect bone by impairing mineralization and reducing calcium absorption, leading to abnormal skeletal development and reduced bone quality (11394,11399,14554,14557). This would manifest as rickets if it occurs during bone growth, and as osteomalacia after growth is complete (14556). The concern is mainly based on animal data, although strontium-related rickets has been observed in children eating plant-derived foods grown in locations with high soil strontium levels (>350 ppm), especially if they also have inadequate protein, calcium, and vitamin D intake (11399,14554,14556,14557). Accumulation of strontium has also been reported in people with end-stage renal disease, especially those on dialysis, and has been linked to osteomalacia in such patients. Elevated serum and bone strontium levels seem to occur more commonly in patients with osteomalacia than in those with other types of renal osteodystrophy or no bone changes. Strontium is thought to accumulate due to reduced renal excretion and also the presence of strontium in dialysis fluids (14554,14555,14557,14559).

Neurologic/CNS ...Orally, strontium ranelate has reportedly caused altered consciousness, memory loss, and seizures on occasion (14549).

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